Senior Pharmacovigilance Safety Scientist – Benefit Risk

About the role

ProPharma is seeking a Senior Pharmacovigilance Safety Scientist to join its Benefit Risk team. The role focuses on delivering high‑quality safety deliverables, coordinating with senior management, and ensuring compliance with regulatory expectations.

Key responsibilities

• Author and quality‑review aggregate safety reports (PSURs, PBRERs, PADERs, DSURs, annual reports) for submission to health authorities.
• Develop, author, and review Risk Management Plans (RMPs) as part of routine pharmacovigilance activities.
• Prepare and review signal management reports and conduct literature searches with validity checks.
• Extract, validate, and reconcile data from safety databases, sales, RSI, and previous reports.
• Generate line listings, perform quality checks, and support high‑priority ad‑hoc tasks.
• Serve as subject‑matter expert during internal and external audits/inspections.
• Mentor and train junior PV scientists and ensure deliverables meet regulatory timelines.

Required profile

• Bachelor’s or Master’s degree in Pharmacy, Nursing, Life Sciences, or a related health field, or equivalent experience.
• Minimum 4 years of pharmacovigilance experience with a focus on Risk Management Plans.
• Proven ability to present metrics, lead quality discussions, and interact with clients.
• Experience in literature screening and authoring safety reports.

Required skills

• Pharmacovigilance processes and regulations
• Risk Management Plan development
• Signal detection and management
• Literature review and validity assessment
• Safety database querying and line‑listing generation