Safety‑Focused Medical Director, Pharmacovigilance

Vivid Resourcing; Boston (MA); On-site; USD 150,000 - 250,000; Full time

Job summary

A leading biotechnology firm in Boston is seeking a Medical Director, Pharmacovigilance to provide medical safety leadership across clinical development and marketed products. The ideal candidate will have significant experience in drug safety, risk assessment, and regulatory compliance. Key responsibilities include overseeing safety evaluations, preparing regulatory submissions, and leading cross-functional teams. Strong communication and analytical skills are essential for success in this strategic role within a fast-paced environment.

Qualifications

• 5–10+ years of industry experience in Pharmacovigilance, Drug Safety, or Clinical Development.
• Demonstrated expertise in AE case assessment, signal detection, and clinical interpretation.
• Strong communication skills with the ability to present complex safety issues.

Responsibilities

• Serve as the medical safety lead for assigned products.
• Conduct ongoing safety surveillance, signal detection, and risk evaluation.
• Lead preparation and review of safety sections for regulatory submissions.

Skills

Medical judgment & clinical decision-making

Safety surveillance & signal detection

Regulatory knowledge (FDA, EMA, ICH, GVP)

Cross-functional leadership

Strong analytical and problem-solving ability

Excellent scientific communication

Strategic and operational PV expertise

High attention to detail & compliance orientation

Education

Medical degree (M.D. or D.O.)

Board certification in relevant specialty

Tools

Safety databases (e.g., Argus, ArisGlobal, Veeva Safety)

Job description

A leading biotechnology firm in Boston is seeking a Medical Director, Pharmacovigilance to provide medical safety leadership across clinical development and marketed products. The ideal candidate will have significant experience in drug safety, risk assessment, and regulatory compliance. Key responsibilities include overseeing safety evaluations, preparing regulatory submissions, and leading cross-functional teams. Strong communication and analytical skills are essential for success in this strategic role within a fast-paced environment.