Manager PV Operations (m/f/d)

Job title: Manager PV Operations (m/f/d)

About the Role

This role functions as an expert in Pharmacovigilance (PV) Operations, overseeing end-to-end adverse event (AE) case processing from collection to submission. It establishes standards for Individual Case Safety Report (ICSR) processing and safety data collection across interventional and non-interventional studies, expanded access programs, market research, and other research activities. The role operates both globally and regionally, supporting senior PV Operations in process management and ensuring compliant data collection.

What You'll Do

• Support appropriate collection of AE data from local and global clinical start-up activities.
• Review clinical study protocols to ensure consistent safety requirements across related studies.
• Develop and maintain study-specific SAE Flow Plans and collaborate on associated documentation.
• Review proposals for clinical solicited activities with Medical Safety and affiliates.
• Participate in contract reviews with third parties and Investigator Initiated Studies to define roles and responsibilities.
• Monitor clinical case workflows to ensure expected volumes and data capture.
• Serve as backup or Global Study Lead representing PV Operations in multidisciplinary study meetings.
• Handle complex clinical ICSR queries and develop training materials for clinical safety data management.
• Support process redesign, SOP ownership, CAPA management, and compliance initiatives within PV Operations.
• Act as SME during audits and inspections; escalate issues and collaborate cross-functionally with affiliates and partners.

What We're Looking For

• Bachelor’s degree in Life Sciences, Pharmacology, or Medicine with 5 to 7 years’ PV experience; advanced degree is a plus.
• Strong understanding of European and international PV regulations.
• Experience in various PV operational areas, especially interventional and non-interventional trials; familiarity with electronic data capture and safety reporting preferred.
• Excellent computer skills and proficient English language abilities.
• Highly reliable with strong attention to detail and ability to meet deadlines with quality work.
• Positive attitude and excellent cross-cultural communication skills.
• Ability to work independently, identify issues, assess impact, and implement effective solutions.

Nice to Have

• Advanced degree is a plus.
• Familiarity with electronic data capture and safety reporting preferred.