Pharmacovigilance Physician II

About the role

Premier Research seeks a Pharmacovigilance Physician II to join its Pharmacovigilance and Records Management team. You will support biotech, medtech, and specialty pharma clients by ensuring the safety of investigational and marketed products, contributing to risk management, and preparing regulatory safety reports.

Key responsibilities

• Conduct medical assessment of all safety‑related data (AEs, SAEs, SUSARs, AESIs) and ensure accurate case narratives and coding.
• Provide analysis of similar events and write safety sections, including benefit‑risk assessments for PSURs, PADERs, DSUR/IND annual reports, and SUSAR line listings.
• Review Safety Management Plans and ensure compliance with ICH GCP, ICH E2A, ISO14155, FDA CFRs, EU regulations, and GVP modules.
• Monitor safety signals, assess risk‑benefit balance, and contribute to Risk Management Plans (RMP) and REMS.
• Attend investigator meetings, interact with site staff and client representatives, and review study documentation (protocol, CRF, IB, budget).
• Support the Head of PV in aligning medical safety processes with the company’s PV strategy.

Required profile

• Medical degree with clinical practice experience (oncology, dermatology, pediatrics, or neuro‑psychiatry preferred).
• 2+ years of experience in a medical or safety department evaluating patient safety data.
• Strong understanding of the global PV regulatory environment, including FDA, EU, and ICH guidance.
• Demonstrated knowledge of medical terminology and safety data handling.

Required skills

• Medical assessment of safety data and case narrative review.
• Safety report writing (PSUR, PADER, DSUR, SUSAR line listings).
• Regulatory knowledge: ICH GCP, ICH E2A, ISO14155, FDA CFRs, EU GVP modules.
• Risk management expertise (RMP, REMS) and signal detection.

What we offer

• Opportunities to work with innovative biotech and pharma companies.
• Professional development and flexible work arrangements.
• Collaborative environment where your ideas influence medical innovation.