Medical Director - Pharmacovigilance (Waltham, MA)

The Medical Director of Pharmacovigilance oversees global pharmacovigilance for marketed and investigational products, managing safety data from clinical trials and post-marketing sources, identifying safety signals, and ensuring benefit-risk assessment. This role reports to the Senior Medical Director and collaborates across multiple levels of management to advance safety insights throughout product lifecycles.
 

• 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.

• 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.

Department: Direct Clients
This is a full time position