Pharmacovigilance Physician

About the role

The Pharmacovigilance Physician provides medical expertise for the evaluation of drug safety data, conducts benefit‑risk assessments, and supports regulatory submissions. This role works closely with clients to ensure compliance with pharmacovigilance regulations and to communicate safety information effectively.

Key responsibilities

• Perform medical review of individual case safety reports (ICSR) and determine benefit‑risk conclusions.
• Analyze aggregate safety data for periodic safety reports (PADER, PSUR, DSUR, PBRER, IND Annual Report) and ad‑hoc regulatory requests.
• Draft, review, and refine medical content for Investigator’s Brochures, Clinical Safety Summaries, product labeling, and risk management documents.
• Lead and participate in safety meetings with clients, safety monitoring boards, and regulatory authorities.
• Support the Qualified Person for Pharmacovigilance and ensure compliance with applicable regulations.
• Contribute to risk management plans and risk evaluation and mitigation strategies.

Required profile

• Licensed medical physician (MD, DO, or equivalent) in good standing with at least 1 year of pharmacovigilance experience, or an unlicensed physician with 10 years of combined pharmacovigilance/clinical experience.
• No record of past or present medical board disciplinary action.
• Strong self‑motivation and organizational abilities.

Required skills

• Pharmacovigilance and safety signal detection.
• Benefit‑risk analysis and medical assessment of safety data.
• Preparation of safety reports (PADER, PSUR, DSUR, PBRER, IND Annual Report).
• Risk management plan development and risk evaluation‑mitigation strategies.
• Regulatory compliance and interaction with health authorities.

What we offer

• Opportunity to work on diverse client portfolios in the pharmaceutical and biotech sectors.
• Collaborative environment with experienced safety professionals.