Associate Medical Safety Director – Sponsor Dedicated

About the role

The Associate Medical Safety Director will support the Lifecycle Safety Medical team by providing pharmacovigilance and risk‑management expertise across product portfolios. The role involves medical evaluation of adverse events, signal detection, and contribution to regulatory submissions.

Key responsibilities

• Provide aggregate safety reviews and maintain oversight of product safety profiles.
• Lead signal detection strategy, review reports, raise potential signals and contribute to safety analysis presentations.
• Conduct medical review for IND Annual Reports, EU Periodic Benefit‑Risk Evaluation Reports, US Periodic Reports and related safety documentation.
• Review and contribute to Development Risk Management Plans, EU Risk Management Plans and US REMS.
• Support benefit‑risk evaluation for clinical trials and post‑marketing settings.
• Oversee safety aspects of label development, review and updates.
• Perform medical review of trial‑related adverse events and post‑marketing ADRs, including narrative, coding and causality assessment.
• Represent safety findings in internal and external stakeholder meetings and safety governance forums.

Required profile

• Medical degree from an accredited, internationally recognized medical school.
• Approximately three years of clinical practice experience.
• At least two years of experience in the pharmaceutical industry or related field, or an equivalent combination of education and experience.
• Knowledge of applicable federal and local regulations and guidelines governing pharmacovigilance and risk management.

Required skills

• Pharmacovigilance expertise.
• Risk management and signal detection.
• Benefit‑risk evaluation.
• Regulatory reporting (e.g., IND, EU PBRER, US PSUR).