Senior Medical Director, Pharmacovigilance

Reporting to the Head of Drug Safety & Pharmacovigilance (PV), the Senior Medical Director will provide hands-on and strategic leadership for Oncology PV activities associated with assigned Boston Biomedical investigational and commercial stage products.  This individual will help build the PV Medical Safety group, and function in a company matrix team environment interacting with several key stakeholders, including Clinical Development, Regulatory Affairs, Biostatistics, Translational Medicine, Medical Affairs, Quality Assurance, and Legal.  

Responsibilities

Leadership Activities

  • Act as a deputy to the Head of Drug Safety & Pharmacovigilance, when necessary
  • Supervise other PV team members; will have one direct report to start, with plans to expand team in the next year
  • Guide and mentor Boston Biomedical staff on PV best practices and help create SOPs and Work Instructions to underlie them
  • Engage with parent company and development partners as needed to ensure shared communication and understanding of PV issues

Program Based Activities

  • All PV and Risk Management activities as Program Safety Lead for assigned products, including a compound in phase 3
  • Complete routine PV activities of assigned programs including formation of the Reference Safety Information, aggregate safety reporting, signal detection, and literature review
  • Lead the cross-functional product Safety Management Team, including escalation of safety issues to senior leadership, as needed
  • Create/update the safety/risk section in protocols, Investigator’s Brochures, informed consent forms, and any other program documents
  • Review and oversight of clinical and non-clinical safety data, and participation in dose escalation discussions for early studies
  • Provide medical safety expertise for monitoring of clinical trials, clinical data, and data safety monitoring boards
  • Write and review clinical study reports and other documents developed for submission to regulatory authorities, including safety sections of NDAs
  • As applicable, work with vendor partners to ensure completion of safety activities in which they are engaged

Qualifications

  • MD (or ex-US equivalent) or PharmD
  • Minimum of 6-10 years of experience in Pharmacovigilance
  • Oncology PV experience strongly preferred
  • Regulatory filing experience preferred
  • Leadership experience including the supervision and mentoring of PV staff
  • Experience working with vendors preferred
  • Knowledge of ICH, US & EU regulations and requirements for pharmacovigilance 
  • Excellent interpersonal skills, with demonstrated ability to work in a multi-disciplinary setting, foster and nurture teamwork, and act as a facilitator to drive fulfillment of corporate strategic goals
  • Strong communication skills with excellent written and spoken English

Job Location: Cambridge, MA

Please send resumes to talentacquisition@bostonbiomedical.com