Medical Director - Pharmacovigilance (Waltham, MA)

Unclassified - Waltham, MA

Full-time - Senior

Waltham, MA

About the position

The Medical Director of Pharmacovigilance is responsible for overseeing global pharmacovigilance activities for both marketed and investigational products. This role involves managing safety data from clinical trials and post-marketing sources, identifying safety signals, and conducting benefit-risk assessments. The position requires collaboration across various management levels to enhance safety insights throughout the product lifecycle.

Responsibilities

• Lead safety surveillance, benefit-risk assessment, and risk management for assigned products.
• Oversee adverse event report review, ensuring consistency and medical interpretation in assessments.
• Provide medical support to cross-functional teams on protocol-related safety topics, including eligibility and patient safety.
• Review and assess trial-related adverse events, serious adverse events, and patient narratives.
• Participate in protocol and clinical document development, including Investigative Drug Brochures and Case Report Forms.
• Support regulatory compliance through safety inspections, audits, and periodic safety reports (e.g., PSUR, DSUR, PADER).
• Drive signal detection, literature reviews, and preparation of regulatory responses, acting as a subject matter expert.
• Attend and contribute to Safety and Product Safety Committee meetings, presenting safety issues and risk mitigation strategies.
• Collaborate with Regulatory Affairs and cross-functional teams on safety concerns, benefit-risk assessments, and risk management plans.
• Provide training and guidance on safety surveillance and medical review processes to team members and vendors.

Requirements

• MD from an accredited medical institution (board certification preferred).
• Minimum of 5 years in pharmacovigilance/drug safety within biopharmaceuticals, with experience in development and marketed products.
• Strong scientific, clinical, and analytical skills, with an ability to assess and interpret safety data.
• Proficiency in MedDRA coding, Microsoft Excel, Word, PowerPoint; experience with safety databases preferred.
• Working knowledge of global drug development and pharmacovigilance regulations.
• Exceptional communication, multitasking, and teamwork skills, with experience presenting to large groups.
• Highly detail-oriented, organized, and able to prioritize tasks effectively in a high-pressure environment.