Pharmacovigilance & Quality Assurance Manager KSA
تفاصيل الوظيفة
Company Overview With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn. We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries. At Recordati, our mantra is simple. We've always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest we want to give people the opportunity to be the best version of themselves. This drive will never stop. Together, we will always be reimagining tomorrow with new ideas, new technologies and new innovations to fight diseases. Recordati. Unlocking the full potential of life. Job Purpose The MENA region (Middle East and North Africa) represents a strategic market for Recordati Rare Diseases. Today, we are expanding our presence in Saudi Arabia with the opening of new offices, marking an important milestone in our journey of long-term growth. By combining our global expertise with the richness of opportunities in the region, we aim to create meaningful value for local communities while reinforcing our position as a key international player. Position Overview The Pharmacovigilance and Quality Assurance Manager is responsible for the overall management of the TSO Quality Management System and quality assurance programs, to foster a strong quality and continuous improvement culture, ensuring that the local license to operate activities meet internal and external requirements (including regulations and good Practices), policies and procedures. In addition, manage the local (KSA) Pharmacovigilance activities, act as the national PV contact, ensure local PV processes are updated and inspection ready, and be the point of contact for Global Patient Safety. Key Responsibilities
- Quality Assurance:
- Act as the local quality assurance/quality system representative for the TSO.
- Establish and maintain TSO Quality Management System and Quality Assurance activities to ensure compliance with all regulatory and GxP requirements.
- Drive remediation plans when a product quality or GxP process issue is identified.
- Maintain and ensure local Product Complaints and recalls management.
- Integrate global/corporate and TSO quality needs and priorities, including representing the TSO at RRD Global Quality Forum.
- Ensure the TSO self-inspection, GxP audit readiness; business continuity, change control, Deviations and CAPA management systems and activities are in place and implemented to cover GxP processes.
- Conduct and/or host risk assessments, self-inspections, regulatory inspections, audits.
- PV Roles & Responsibilities:
- Create the local standard operating procedures (SOPs) to handle all the pharmacovigilance activities to be compatible in accordance with the regulation on the SFDA variations guidelines.
- Act as the local PV contact for RRD Global Patient Safety (GPS).
- Provide Pharmacovigilance oversight to the delivery of Risk Management Plans in conjunction with the cross-functional team.
- Support the business through the provision of drug safety expertise in the review and approval of activities such as Patient Support Programs and Patient Data Collection Systems.
- Act as the pharmacovigilance contact for the SFDA 24/7, and be the contact point for any PV inspections.
- PV Cross-functional And Oversight Role:
- Liaise with all functions including Commercial partners, Service Providers, third parties, and other RRD functions like medical affairs, regulatory affairs, medical information etc. to have an overview of processes impacting PV affiliate workflows.
- Demonstrate scientific and business expertise relevant to therapeutic areas, including products, disease state management, emerging therapies, and the competitive landscape.
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