Operations Specialist Manager (m/w/d)

As an Operations Specialist Manager (m/w/d) , you will apply knowledge and expertise including complex decision-making activities to review, assess and process Safety data and information across service lines. You will provide oversight on small to medium service operational projects and act as mentor to junior members of staff. You may also act as functional lead on medium to large operational projects. May perform listed job duties in the following groups: Regulatory Reporting, Safety Operations, AE Intake, Medical Information, and PV Standards. MAIN RESPONSIBILITIES

1. Contribute knowledge and expertise to or lead assigned deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.
2. Ensure adherence to compliance, quality, productivity and delivery standards per project requirements.
3. Establish and maintain effective team and project service operations communications.
4. Provide oversight role and have a good understanding of operational team on status, metrics, productivity and initiatives.
5. Maintain a thorough understanding of project protocol, therapeutic indication, budget and scope of work for assigned projects.
6. Set up and maintain project files, standard templates, electronic forms, databases and workflow as per project requirement.
7. Process Safety data according to applicable regulations, guidelines, Standard Operating procedures and project requirements.
8. Perform Pharmacovigilance activities per project requirement.
9. Perform activities related to adjudication as applicable.
10. Assess Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to meet requirement as per project.
11. Liaise with relevant stakeholders to facilitate expedited reporting.
12. Liaise with manager for regulatory tracking requirements and electronic reporting.
13. When acting as functional lead define and document safety reporting procedures in line with IQVIA or customer SOPs, including working with Lifecycle Safety Systems or customer IT teams to ensure regulatory reporting rules and gateways are in place and appropriate delegation for reporting are documented.
14. Provide effective feedback on project performance to junior members of team.
15. Participate or lead trainings across Safety process service offerings.

1. Bachelor's degree in life sciences or related field.
2. Excellent knowledge of medical terminology.
3. Up to 5 years of relevant experience, inclusive of up to 3 years of Pharmacovigilance experience.
4. In depth knowledge and understanding of applicable Safety Database.
5. Very good understanding of applicable global, regional, local clinical research regulatory requirements.
6. Excellent working knowledge of Microsoft Office and web-based applications.

1. Excellent organizational skills, attention to detail and accuracy.
2. Sound judgment and decision-making skills.
3. Demonstrate high quality standards.
4. Establish and maintain effective communication and working relationships with co-workers, managers and clients.
5. Ability to work effectively on multiple projects simultaneously, organize own workload and effectively manage teams’ priorities.
6. Skill to plan workload based on available capacity and ability to change prioritization based on workload fluctuations.
7. Proven ability to work independently and autonomously with policies and practices.
8. Skill to negotiate and work on finding a central ground that is satisfactory to all concerned stakeholders.