Associate Director / Director of Drug Safety / PV (Boston)

Location : Boston

Reports to : Senior Director Pharmacovigilance

Department : Pharmacovigilance / Drug Safety

Role Summary

The Director of Pharmacovigilance will lead and oversee all aspects of post-marketing and clinical safety surveillance activities, ensuring compliance with global regulatory requirements, best practices, and company policies. This role entails strategic planning, maintenance and continuous improvement of the pharmacovigilance system (PVS), oversight of risk management, signal detection, safety reporting, and communication with health authorities.

The incumbent will work closely with clinical development, regulatory affairs, quality, medical affairs, and manufacturing to ensure safety is integrated through the lifecycle of the companys pipeline.

Qualifications / Skills

• Qualified MD
• Minimum of 10 years of experience in pharmacovigilance / drug safety in the biotech / pharma industry, with at least 3-5 years in a leadership role.
• Strong extensive experience in Oncology.
• Strong knowledge of global regulatory requirements in pharmacovigilance : FDA, EMA, ICH, MHRA, etc.; good understanding of local country requirements in key markets (Japan, China, etc.) is a plus.
• Experience developing and overseeing Risk Management Plans, RMP / PSUR / DSUR preparation, signal detection & management.
• Proven track record of handling inspections / audits by regulatory authorities related to PV.
• Excellent analytical skills, ability to interpret safety data, derive insights, summarize for multiple audiences (scientific, regulatory, executive).
• Leadership & communication skills : able to lead a team, collaborate cross-functionally, influence senior management.
• Proficiency in use of safety databases, electronic reporting systems, signal detection tools, safety-oriented metrics dashboards.

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