Detalhes do emprego
Position Safety Officer- Deputy Country Safety Head Job Location: İstanbul Job Type: Permanent, Full time At Sanofi CHC, we have one shared purpose – we work passionately, every day, to ‘serve healthier, fuller lives. Our marketing philosophy is driven by this purpose and everything we do is centered around people, our customers, healthcare professionals, and our employees, across the world. We are building brands that serve 1bn consumers worldwide, so that they can live healthier, fuller lives. In order to do this better than anybody else, we aspire to become the most consumer-centric Fast Moving Consumer Healthcare Business. We want to be market shapers and achieve category leadership in the categories that we play in – delivered through strong global-local partnership. We are a people first business, placing consumers at the heart of everything we do through uncovering and activating deep consumer and shopper insights, for example. As a top 3 global CHC player, we want to raise the bar in terms of our strategic and operational capabilities to enable sustainable, above-market growth. In order to achieve this, we need strong talents that will help us shape the future of CHC while sharing our core values of courage, teamwork, respect, and integrity. Main Responsibilities:
- Supports the Country Safety Head in country related PV activities.
- Deputizes for the CSH in times of planned or unplanned absence of the CSH.
- Is nominated as deputy local Responsible Person for Pharmacovigilance (RPP) for the CHC products where applicable per national regulations.
- Supports the CSH in ensuring that local PV activities in Turkey are performed in compliance with the Global PV policies, as well as global, regional and local PV regulations to warrant safe and appropriate use of CHC products on the market in the assigned country.
- Builds close and robust relations/collaboration with the in-country partner functions, including but not limited to Medical, Regulatory, Quality, Commercial, Legal, and Country Manager.
- Ensure all necessary information is promptly collected, entered into the safety database and forwarded to the data processing unit within specified timeframes for both initial and follow-up adverse event reports.
- Responsible for the accuracy and completeness of information reported from various sources for CHC products
- Conduct follow-up activities on ICSRs as per national requirements and company standard operating procedures (SOPs).
- Responsible for timely submission of ICSRs to the Ministry of Health (MoH) in accordance with national regulations for expedited reporting.
- Responsible for ensuring reconciliation activities of case reports with business partners, and internal functions in the company are performed.
- Support the maintenance of local quality documents owned by PV to include documented reviews, gap assessments and revisions as per global requirements.
- Support the maintenance of the local PV System Master File for Turkey as required and in accordance with local regulations and the global standards.
- Contribute to education and training on PV and relevant safety topics within the local organization.
- Maintain local compliance metrics and ensure data capture in the appropriate tools.
- Support PV process non-compliance investigation, Root Cause Analysis (RCA), Corrective Actions/Preventive Actions (CAPAs) implementation including appropriate documentation.
- Support the completion of audit and inspection observations in close interaction with Global /Local Functions
- Handle appropriately local periodic reports, including periodic safety reports (PSRs) and periodic reviews, and contribute together with Global PV, Clinical Operations and RA departments to the planning for PSRs ,
- Screen local scientific / medical literature and management of relevant abstract/articles
- Support the implementation and monitor the PV requirements for global, regional and local programs (e.g. Patient Support Program, Market Research, Managed Access Program…), and company sponsored digital media
- Contribute to screening and analysis of national regulations, and forward any future/new/updated PV regulation as per defined processes
- In case of local outsourcing of PV activities to third parties (i.e. vendors/service providers/CROs), support the monitoring of the appropriate execution of outsourced activities.
- Support the Global PV and particularly the QPPV with local safety surveillance activities
- Contribute to the development of local RMP, when applicable, with the support and validation of the Risk Management Expert. Track the actual implementation of additional Risk Minimization Measures (aRMMs) in Turkey.
- Support Regional/Zone PV Lead to monitor the appropriate execution of a local or regional SDEA
- Support the Country Safety Head in ensuring high standards of pharmacovigilance and maintaining readiness for regulatory inspections.
- Support the Country Safety Head in developing and maintaining standardized operating procedures (SOPs) for pharmacovigilance activities in Turkey in accordance with local regulatory requirements and international best practices.
- Bachelor’s degree (or higher) in a health profession (i.e. Pharmacy, Medicine)
- At least 2 years of experience in pharmacovigilance and safety department of pharmaceutical companies
- Knowledge and understanding of local and global procedures as applicable.
- Knowledge of legislation with regards to relevant national regulatory guidelines, directives, and regulations in Pharmacovigilance
- Fluency in English language (both verbally and written)
- Interpersonal communication skills
- Attention to detail
- Basic computer skills (MS Outlook, Word, Excel, Power Point)
- Strong knowledge of safety database systems
Pursue progress , discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!Apply safely
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Our marketing philosophy is driven by this purpose and everything we do is centered around people, our customers, healthcare professionals, and our employees, across the world. </em></p><p><em> We are building brands that serve 1bn consumers worldwide, so that they can live healthier, fuller lives. In order to do this better than anybody else, we aspire to become the most consumer-centric Fast Moving Consumer Healthcare Business. We want to be market shapers and achieve category leadership in the categories that we play in – delivered through strong global-local partnership. We are a people first business, placing consumers at the heart of everything we do through uncovering and activating deep consumer and shopper insights, for example. </em></p><p><em> As a top 3 global CHC player, we want to raise the bar in terms of our strategic and operational capabilities to enable sustainable, above-market growth. In order to achieve this, we need strong talents that will help us shape the future of CHC while sharing our core values of courage, teamwork, respect, and integrity. </em></p><p> Main Responsibilities: </p><ul><li> Supports the Country Safety Head in country related PV activities. </li><li> Deputizes for the CSH in times of planned or unplanned absence of the CSH. </li><li> Is nominated as deputy local Responsible Person for Pharmacovigilance (RPP) for the CHC products where applicable per national regulations. </li><li> Supports the CSH in ensuring that local PV activities in Turkey are performed in compliance with the Global PV policies, as well as global, regional and local PV regulations to warrant safe and appropriate use of CHC products on the market in the assigned country. </li><li> Builds close and robust relations/collaboration with the in-country partner functions, including but not limited to Medical, Regulatory, Quality, Commercial, Legal, and Country Manager. </li></ul><p> Adverse Event (AE) Management Responsibilities: </p><ul><li> Ensure all necessary information is promptly collected, entered into the safety database and forwarded to the data processing unit within specified timeframes for both initial and follow-up adverse event reports. </li><li> Responsible for the accuracy and completeness of information reported from various sources for CHC products </li><li> Conduct follow-up activities on ICSRs as per national requirements and company standard operating procedures (SOPs). </li><li> Responsible for timely submission of ICSRs to the Ministry of Health (MoH) in accordance with national regulations for expedited reporting. </li><li> Responsible for ensuring reconciliation activities of case reports with business partners, and internal functions in the company are performed. </li></ul><p> Organization and maintenance of local PV Quality system </p><ul><li> Support the maintenance of local quality documents owned by PV to include documented reviews, gap assessments and revisions as per global requirements. </li><li> Support the maintenance of the local PV System Master File for Turkey as required and in accordance with local regulations and the global standards. </li><li> Contribute to education and training on PV and relevant safety topics within the local organization. </li><li> Maintain local compliance metrics and ensure data capture in the appropriate tools. </li><li> Support PV process non-compliance investigation, Root Cause Analysis (RCA), Corrective Actions/Preventive Actions (CAPAs) implementation including appropriate documentation. </li><li> Support the completion of audit and inspection observations in close interaction with Global /Local Functions </li></ul><p> Organization and Maintenance of PV Operating System </p><p> In compliance with PV regulatory requirements and company procedures/guidelines, </p><ul><li> Handle appropriately local periodic reports, including periodic safety reports (PSRs) and periodic reviews, and contribute together with Global PV, Clinical Operations and RA departments to the planning for PSRs , </li><li> Screen local scientific / medical literature and management of relevant abstract/articles </li><li> Support the implementation and monitor the PV requirements for global, regional and local programs (e.g. Patient Support Program, Market Research, Managed Access Program…), and company sponsored digital media </li><li> Contribute to screening and analysis of national regulations, and forward any future/new/updated PV regulation as per defined processes </li><li> In case of local outsourcing of PV activities to third parties (i.e. vendors/service providers/CROs), support the monitoring of the appropriate execution of outsourced activities. </li><li> Support the Global PV and particularly the QPPV with local safety surveillance activities </li><li> Contribute to the development of local RMP, when applicable, with the support and validation of the Risk Management Expert. Track the actual implementation of additional Risk Minimization Measures (aRMMs) in Turkey. </li><li> Support Regional/Zone PV Lead to monitor the appropriate execution of a local or regional SDEA </li></ul><p> Standards and Inspection Readiness </p><ul><li> Support the Country Safety Head in ensuring high standards of pharmacovigilance and maintaining readiness for regulatory inspections. </li><li> Support the Country Safety Head in developing and maintaining standardized operating procedures (SOPs) for pharmacovigilance activities in Turkey in accordance with local regulatory requirements and international best practices. </li></ul><p> JOB HOLDER REQUİREMENTS </p><p> Qualifications: </p><ul><li> Bachelor’s degree (or higher) in a health profession (i.e. Pharmacy, Medicine) </li><li> At least 2 years of experience in pharmacovigilance and safety department of pharmaceutical companies </li><li> Knowledge and understanding of local and global procedures as applicable. </li><li> Knowledge of legislation with regards to relevant national regulatory guidelines, directives, and regulations in Pharmacovigilance </li><li> Fluency in English language (both verbally and written)</li><li> Interpersonal communication skills </li><li> Attention to detail </li><li> Basic computer skills (MS Outlook, Word, Excel, Power Point)</li><li> Strong knowledge of safety database systems </li></ul><p></p><p> Pursue progress, discover extraordinary. </p><p> Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. </p><p> At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. </p><p> Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!</p><p> At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. </p><h2> Pursue <em> progress </em> , discover <em> extraordinary </em></h2><p> Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. 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array( 'name' => 'Sri Lanka', 'country_id' => '123', 'country_code' => 'lk', 'slug' => 'sri-lanka', 'global_location_id' => '200', 'rel_gloc_ids' => '200,1047,1048,1049,1084,1085,1086', 'currency' => 'LKR', 'currency_name' => 'Sri Lankan rupee', 'languages' => 'en', 'default_language' => 'en', 'country_time_zone' => 'Asia/Colombo', 'job_location' => '1', 'published' => '1', 'show' => '1' ), 'united-kingdom' => array( 'name' => 'United Kingdom', 'country_id' => '74', 'country_code' => 'gb', 'slug' => 'united-kingdom', 'global_location_id' => '226', 'rel_gloc_ids' => '226,1035,1036,1037,1038,1039,1040,1041,1042,1043,1044,1045,1046,1050,1259,1260,1261,1267', 'currency' => 'GBP', 'currency_name' => 'British Pound', 'languages' => 'en', 'default_language' => 'en', 'country_time_zone' => 'Europe/London', 'job_location' => '1', 'published' => '1', 'show' => '1' ), 'malaysia' => array( 'name' => 'Malaysia', 'country_id' => '149', 'country_code' => 'my', 'slug' => 'malaysia', 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'115', 'nondiscounted_base_price' => '133', 'currency' => 'GBP', 'discount' => '55% off through Laimoon!', 'free_trial_text' => '', 'laimoon_offer' => '1', 'summary' => '<p><strong>What's included in this course? </strong></p><p>The pricing indicated on this page includes the course, examination, and certificate fees. Upon successful completion, the certificate will be issued by IOSH (Institution of Occupational Safety and Health), will then be posted to us, and will be delivered to your location,from the UK. This also includes 3 months of tutor and admin support. VAT charges (excluded in the price) will apply for UK based students. </p><p><strong>Why should you consider taking IOSH online? </strong></p><p>An IOSH e-learning certification is worth the same as a classroom-based qualification. In fact, the certificate you receive at the end of your course won't even mention the method of study. You can start at your own schedule, without having to leave the comfort of your own home. In addition, taking the course online is more affordable than taking it on a typical classroom-based setup. </p><p><strong>Course Overview</strong></p><br><p>The IOSH Working Safely Online course is suitable for any worker in any industry. Nationally recognised and respected, it is aimed at people at all levels and it meets the government's guidelines for introductory health and safety training. This e-learning course aims to ensure that delegates appreciate the importance of risk management and know how to make a difference to the health, safety and wellbeing of themselves and others by changing their behaviour.</p><p><strong>Programme</strong></p><ul><li>Module 1: Introducing working safely </li><li>Module 2: Defining hazard and risk </li><li>Module 3: Identifying common hazards </li><li>Module 4: Improving safety performance </li><li>Module 5: Protecting our environment</li></ul><p><strong>Study Method</strong></p><p>The IOSH Working Safely online course allows you to study when and where you wish, and at your own pace. Our online system is available 24 hours a day, 7 days a week. The system is easy to use, with clear navigation menus and structure. </p><p>The course can be taken on your PC, Mac, Tablet or Smartphone. You can resume your learning from any device at any time. </p><p>The training programme is highly interactive and it includes a range of activities and quizzes to help review and reinforce learning. We also provide mock assessments that are marked automatically, meaning you benefit from instant feedback. These tests help you to practice for your final assessments. </p><p>Each module of the Working Safely course includes the following elements: </p><ul><li>Required learning outcomes - an overview of the module and what should be learnt </li><li>Videos and animations to bring the learning to life </li><li>Additional support materials </li><li>Interactive learning and review exercises </li><li>Links to additional supplementary reference materials and legislation</li></ul><p><strong>Support</strong></p><p>Our expert tutors are on hand to provide full support for the duration of your course. They can be contacted by phone, email, Skype or via our technical tutor support messaging system. </p><p><strong>Certification </strong></p><p>There are two assessment elements to this course and delegates must complete both in order to receive the relevant certificate. These elements are a final multiple choice assessment and a hazard spotting exercise. Both assessments are automatically marked and immediate feedback given on results. </p><p>Learners should aim to complete their study hours, exercises and assessments within one month of starting the course. Note that registration with IOSH is restricted to three months from purchase. This allows time for one resit, the cost of which is included within the price of the online course. After this three-month period has elapsed, students may be subject to re-registration fees.</p><p><strong>Cancellation Policy</strong></p><p>For this course, exam, and certification package, no refunds or cancellations can be offered once login and access details have been provided, as a third party awarding body (IOSH) is involved in the certification process.</p><p><strong>Phoenix Health & Safety Pass Pledge </strong></p><p>Phoenix Health & Safety offer a pass pledge on all IOSH courses. This means that candidates are entitled to continue studying (free of charge) if they fail to meet the required standard in the examinations. </p><p>We're confident that you'll pass the course first time and we have a range of revision materials to help with your studies, as well as audio books and supportive Facebook groups.</p>', 'outline' => '', 'who_should_take_this_course' => '', 'eligibility' => 'The IOSH Working Safely Online course is suitable for any worker in any industry. 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Upon successful completion, the certificate will be issued by IOSH (Institution of Occupational Safety and Health), will then be posted to us, and will be delivered to your location,from the UK. This also includes 3 months of tutor and admin support. VAT charges (excluded in the price) will apply for UK based students. </p><p><strong>Why should you consider taking IOSH online? </strong></p><p>An IOSH e-learning certification is worth the same as a classroom-based qualification. In fact, the certificate you receive at the end of your course won't even mention the method of study. You can start at your own schedule, without having to leave the comfort of your own home. In addition, taking the course online is more affordable than taking it on a typical classroom-based setup. </p><p><strong>Course Overview</strong></p><br><p>The IOSH Working Safely Online course is suitable for any worker in any industry. Nationally recognised and respected, it is aimed at people at all levels and it meets the government's guidelines for introductory health and safety training. This e-learning course aims to ensure that delegates appreciate the importance of risk management and know how to make a difference to the health, safety and wellbeing of themselves and others by changing their behaviour.</p><p><strong>Programme</strong></p><ul><li>Module 1: Introducing working safely </li><li>Module 2: Defining hazard and risk </li><li>Module 3: Identifying common hazards </li><li>Module 4: Improving safety performance </li><li>Module 5: Protecting our environment</li></ul><p><strong>Study Method</strong></p><p>The IOSH Working Safely online course allows you to study when and where you wish, and at your own pace. Our online system is available 24 hours a day, 7 days a week. The system is easy to use, with clear navigation menus and structure. </p><p>The course can be taken on your PC, Mac, Tablet or Smartphone. You can resume your learning from any device at any time. </p><p>The training programme is highly interactive and it includes a range of activities and quizzes to help review and reinforce learning. We also provide mock assessments that are marked automatically, meaning you benefit from instant feedback. These tests help you to practice for your final assessments. </p><p>Each module of the Working Safely course includes the following elements: </p><ul><li>Required learning outcomes - an overview of the module and what should be learnt </li><li>Videos and animations to bring the learning to life </li><li>Additional support materials </li><li>Interactive learning and review exercises </li><li>Links to additional supplementary reference materials and legislation</li></ul><p><strong>Support</strong></p><p>Our expert tutors are on hand to provide full support for the duration of your course. They can be contacted by phone, email, Skype or via our technical tutor support messaging system. </p><p><strong>Certification </strong></p><p>There are two assessment elements to this course and delegates must complete both in order to receive the relevant certificate. These elements are a final multiple choice assessment and a hazard spotting exercise. Both assessments are automatically marked and immediate feedback given on results. </p><p>Learners should aim to complete their study hours, exercises and assessments within one month of starting the course. Note that registration with IOSH is restricted to three months from purchase. This allows time for one resit, the cost of which is included within the price of the online course. After this three-month period has elapsed, students may be subject to re-registration fees.</p><p><strong>Cancellation Policy</strong></p><p>For this course, exam, and certification package, no refunds or cancellations can be offered once login and access details have been provided, as a third party awarding body (IOSH) is involved in the certification process.</p><p><strong>Phoenix Health & Safety Pass Pledge </strong></p><p>Phoenix Health & Safety offer a pass pledge on all IOSH courses. This means that candidates are entitled to continue studying (free of charge) if they fail to meet the required standard in the examinations. </p><p>We're confident that you'll pass the course first time and we have a range of revision materials to help with your studies, as well as audio books and supportive Facebook groups.</p>', 'outline' => '', 'who_should_take_this_course' => '', 'career_path' => 'HSE Manager,HSE Officer,Safety Officer', 'eligibility' => 'The IOSH Working Safely Online course is suitable for any worker in any industry. 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You don't have to sit in a stuffy classroom for four days and drink horrible coffee while eating stale sandwiches. Your online course will enable to you get on with your schedule AND take the course. It's less expensive too which is nice for those who need to manage their budgets.<br></p><ul><li>100% Pass Rate! </li><li>Full tutor support included </li><li>Study at your own pace </li><li>100% Money Back Guaranteed!</li></ul><p><strong>IOSH Managing Safely Course Overview</strong></p><ul><li><strong>Assessing Risks</strong> - Risk assessments and a simple scoring system are introduced in this module, and delegates are given the chance to execute both.</li><li><strong>Investigating Accidents And Incidents</strong> - This sheds light on the importance of determining the "path" of workplace accidents, and how to properly go about it.</li><li><strong>Identifying Hazards</strong> - This is where all main issues of any operation are tackled - everything from entrances and exits, to work traffic, to fire, to chemicals, electricity, and so much more are discussed.</li><li><strong>Measuring Performance</strong> - This explains how checking performance contributes to the improvement of health and safety in a work environment through basic performance indicators, auditing, and proactive and reactive measuring.</li><li><strong>Understanding Your Responsibilities </strong> - This module rounds up the demands of the law and how the legal system works in reinforcing a health and safety management system.</li><li><strong>Controlling Risks</strong> - This examines how risks can be fully controlled or reduced through specific techniques and methods.</li><li><strong>Protecting Our Environment</strong> - This module provides a comprehensive introduction to the value of environmental responsibility of operations and how managers have the power to minimise environmental impacts.</li><li><strong>Introducing Managing Safely</strong> - This module reinforces the role of managers in making sure all members of their team understand the significance and uphold the principles of managing safely.</li></ul><p><strong>What's included in this course? </strong></p><p>The pricing indicated on this page includes the course, examination, and certificate fees. Upon successful completion, the certificate will be issued by IOSH (Institution of Occupational Safety and Health), will then be posted to us, and will be delivered to your location, from the UK. VAT charges (excluded in the price) will only apply for UK/EU based students. </p><br><p><strong>Frequently Asked Questions</strong></p><p><strong>1. What is the IOSH Managing Safely eLearning Course?</strong></p><p>The IOSH Managing Safely eLearning course is the perfect way for you to gain this highly respected certificate in the comfort of you own home or office. Your course is entirely online which mean you don't have to travel to a training venue. This helps save time and money! </p><p><strong>This online course is the EXACT same course as the classroom taught course. As a matter of fact, the certificate you will receive after you pass the course is the same as well.</strong></p><p><strong>2. What are the benefits of taking the training course?</strong></p><p>The course is not designed to turn people into safety experts. However, all who choose to take it have much to gain in learning why health and safety are integral to what they do as industry professionals, and the benefits of being "informed" can extend to their own personal lives. </p><p>By passing this course and having your certificate, you are showing your current or future employer that you are serious about health and safety and have the ability to manage common hazards and risks in the workplace. It will certainly set you out from the crowd if you are looking for new employment or trying for a new position at work.</p> <p>Basically, it's a training course designed to teach managers and supervisors to effectively implement the practical actions in handling health and safety in their teams.</p><p><strong>3. 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You don't have to sit in a stuffy classroom for four days and drink horrible coffee while eating stale sandwiches. Your online course will enable to you get on with your schedule AND take the course. It's less expensive too which is nice for those who need to manage their budgets.<br></p><ul><li>100% Pass Rate! </li><li>Full tutor support included </li><li>Study at your own pace </li><li>100% Money Back Guaranteed!</li></ul><p><strong>IOSH Managing Safely Course Overview</strong></p><ul><li><strong>Assessing Risks</strong> - Risk assessments and a simple scoring system are introduced in this module, and delegates are given the chance to execute both.</li><li><strong>Investigating Accidents And Incidents</strong> - This sheds light on the importance of determining the "path" of workplace accidents, and how to properly go about it.</li><li><strong>Identifying Hazards</strong> - This is where all main issues of any operation are tackled - everything from entrances and exits, to work traffic, to fire, to chemicals, electricity, and so much more are discussed.</li><li><strong>Measuring Performance</strong> - This explains how checking performance contributes to the improvement of health and safety in a work environment through basic performance indicators, auditing, and proactive and reactive measuring.</li><li><strong>Understanding Your Responsibilities </strong> - This module rounds up the demands of the law and how the legal system works in reinforcing a health and safety management system.</li><li><strong>Controlling Risks</strong> - This examines how risks can be fully controlled or reduced through specific techniques and methods.</li><li><strong>Protecting Our Environment</strong> - This module provides a comprehensive introduction to the value of environmental responsibility of operations and how managers have the power to minimise environmental impacts.</li><li><strong>Introducing Managing Safely</strong> - This module reinforces the role of managers in making sure all members of their team understand the significance and uphold the principles of managing safely.</li></ul><p><strong>What's included in this course? </strong></p><p>The pricing indicated on this page includes the course, examination, and certificate fees. Upon successful completion, the certificate will be issued by IOSH (Institution of Occupational Safety and Health), will then be posted to us, and will be delivered to your location, from the UK. VAT charges (excluded in the price) will only apply for UK/EU based students. </p><br><p><strong>Frequently Asked Questions</strong></p><p><strong>1. What is the IOSH Managing Safely eLearning Course?</strong></p><p>The IOSH Managing Safely eLearning course is the perfect way for you to gain this highly respected certificate in the comfort of you own home or office. Your course is entirely online which mean you don't have to travel to a training venue. This helps save time and money! </p><p><strong>This online course is the EXACT same course as the classroom taught course. As a matter of fact, the certificate you will receive after you pass the course is the same as well.</strong></p><p><strong>2. What are the benefits of taking the training course?</strong></p><p>The course is not designed to turn people into safety experts. However, all who choose to take it have much to gain in learning why health and safety are integral to what they do as industry professionals, and the benefits of being "informed" can extend to their own personal lives. </p><p>By passing this course and having your certificate, you are showing your current or future employer that you are serious about health and safety and have the ability to manage common hazards and risks in the workplace. It will certainly set you out from the crowd if you are looking for new employment or trying for a new position at work.</p> <p>Basically, it's a training course designed to teach managers and supervisors to effectively implement the practical actions in handling health and safety in their teams.</p><p><strong>3. What is the exam like?</strong></p><p>The exam for this course is entirely online and consists of a 30 question multiple choice exam as well as a risk assessment project that you email back to us using the forms that are provided. </p><p>The exam process is super easy and you can complete it in the comfort of your own home or office. There isn't any need to drive to an exam centre. Stay at home and complete it wearing just your shorts if you wish. We don't mind!</p><br>', 'outline' => '', 'who_should_take_this_course' => 'The IOSH Managing Safely Training course is intended for managers, supervisors, directors and other key personnel. 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Our marketing philosophy is driven by this purpose and everything we do is centered around people, our customers, healthcare professionals, and our employees, across the world. </em></p><p><em> We are building brands that serve 1bn consumers worldwide, so that they can live healthier, fuller lives. In order to do this better than anybody else, we aspire to become the most consumer-centric Fast Moving Consumer Healthcare Business. We want to be market shapers and achieve category leadership in the categories that we play in – delivered through strong global-local partnership. We are a people first business, placing consumers at the heart of everything we do through uncovering and activating deep consumer and shopper insights, for example. </em></p><p><em> As a top 3 global CHC player, we want to raise the bar in terms of our strategic and operational capabilities to enable sustainable, above-market growth. In order to achieve this, we need strong talents that will help us shape the future of CHC while sharing our core values of courage, teamwork, respect, and integrity. </em></p><p> Main Responsibilities: </p><ul><li> Supports the Country Safety Head in country related PV activities. </li><li> Deputizes for the CSH in times of planned or unplanned absence of the CSH. </li><li> Is nominated as deputy local Responsible Person for Pharmacovigilance (RPP) for the CHC products where applicable per national regulations. </li><li> Supports the CSH in ensuring that local PV activities in Turkey are performed in compliance with the Global PV policies, as well as global, regional and local PV regulations to warrant safe and appropriate use of CHC products on the market in the assigned country. </li><li> Builds close and robust relations/collaboration with the in-country partner functions, including but not limited to Medical, Regulatory, Quality, Commercial, Legal, and Country Manager. </li></ul><p> Adverse Event (AE) Management Responsibilities: </p><ul><li> Ensure all necessary information is promptly collected, entered into the safety database and forwarded to the data processing unit within specified timeframes for both initial and follow-up adverse event reports. </li><li> Responsible for the accuracy and completeness of information reported from various sources for CHC products </li><li> Conduct follow-up activities on ICSRs as per national requirements and company standard operating procedures (SOPs). </li><li> Responsible for timely submission of ICSRs to the Ministry of Health (MoH) in accordance with national regulations for expedited reporting. </li><li> Responsible for ensuring reconciliation activities of case reports with business partners, and internal functions in the company are performed. </li></ul><p> Organization and maintenance of local PV Quality system </p><ul><li> Support the maintenance of local quality documents owned by PV to include documented reviews, gap assessments and revisions as per global requirements. </li><li> Support the maintenance of the local PV System Master File for Turkey as required and in accordance with local regulations and the global standards. </li><li> Contribute to education and training on PV and relevant safety topics within the local organization. </li><li> Maintain local compliance metrics and ensure data capture in the appropriate tools. </li><li> Support PV process non-compliance investigation, Root Cause Analysis (RCA), Corrective Actions/Preventive Actions (CAPAs) implementation including appropriate documentation. </li><li> Support the completion of audit and inspection observations in close interaction with Global /Local Functions </li></ul><p> Organization and Maintenance of PV Operating System </p><p> In compliance with PV regulatory requirements and company procedures/guidelines, </p><ul><li> Handle appropriately local periodic reports, including periodic safety reports (PSRs) and periodic reviews, and contribute together with Global PV, Clinical Operations and RA departments to the planning for PSRs , </li><li> Screen local scientific / medical literature and management of relevant abstract/articles </li><li> Support the implementation and monitor the PV requirements for global, regional and local programs (e.g. Patient Support Program, Market Research, Managed Access Program…), and company sponsored digital media </li><li> Contribute to screening and analysis of national regulations, and forward any future/new/updated PV regulation as per defined processes </li><li> In case of local outsourcing of PV activities to third parties (i.e. vendors/service providers/CROs), support the monitoring of the appropriate execution of outsourced activities. </li><li> Support the Global PV and particularly the QPPV with local safety surveillance activities </li><li> Contribute to the development of local RMP, when applicable, with the support and validation of the Risk Management Expert. Track the actual implementation of additional Risk Minimization Measures (aRMMs) in Turkey. </li><li> Support Regional/Zone PV Lead to monitor the appropriate execution of a local or regional SDEA </li></ul><p> Standards and Inspection Readiness </p><ul><li> Support the Country Safety Head in ensuring high standards of pharmacovigilance and maintaining readiness for regulatory inspections. </li><li> Support the Country Safety Head in developing and maintaining standardized operating procedures (SOPs) for pharmacovigilance activities in Turkey in accordance with local regulatory requirements and international best practices. </li></ul><p> JOB HOLDER REQUİREMENTS </p><p> Qualifications: </p><ul><li> Bachelor’s degree (or higher) in a health profession (i.e. Pharmacy, Medicine) </li><li> At least 2 years of experience in pharmacovigilance and safety department of pharmaceutical companies </li><li> Knowledge and understanding of local and global procedures as applicable. </li><li> Knowledge of legislation with regards to relevant national regulatory guidelines, directives, and regulations in Pharmacovigilance </li><li> Fluency in English language (both verbally and written)</li><li> Interpersonal communication skills </li><li> Attention to detail </li><li> Basic computer skills (MS Outlook, Word, Excel, Power Point)</li><li> Strong knowledge of safety database systems </li></ul><p></p><p> Pursue progress, discover extraordinary. </p><p> Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. </p><p> At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. </p><p> Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!</p><p> At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. </p><h2> Pursue <em> progress </em> , discover <em> extraordinary </em></h2><p> Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. 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Safety Officer (Pharmacogivilance) - Deputy Country Safety Head Turkey at sanofi. Please apply or share https://jobs.laimoon.com/jobs/externalview/43024041' $emailText = 'Hiring now! Safety Officer (Pharmacogivilance) - Deputy Country Safety Head Turkey at sanofi. 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Hiring company
Sanofi
Sanofi multinational pharmaciieutical company in Egypt
Ibd3a Academy in Egypt
Brooklen Academy-
IOSH Working Safely with Exam & Certificate Phoenix Health & SafetyAED 391
AED 489Duração: 8 Hours -
IOSH Managing Safely Wise Global Training LtdAED 1,145
AED 1,553Duração: 24 Hours
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