Senior Medical Director, Pharmacovigilance – Early Stage

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 Sumitomo Dannipon Pharma Oncology investigational products. This individual will manage the PV Medical Safety early stage group, function as a Safety Lead for products as needed, and work in a company matrix team environment interacting with several key stakeholders, including Clinical Development, Regulatory Affairs, Translational Medicine, Biostatistics, and Clinical Pharmacology.

Responsibilities

  • Provide managerial and strategic leadership within the Drug Safety & Pharmacovigilance Department for the early stage Medical Safety group.
  • Represent PV cross-functionally and provide subject matter expertise at the team and larger company levels as required.
  • Perform all PV and Risk Management activities as Safety Lead for assigned products.
  • 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, and informed consent forms.
  • 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 and data and safety monitoring boards.
  • Write and review clinical study reports and other documents developed for submission to regulatory authorities, including safety sections of NDAs.
  • Guide and mentor Sumitomo Dannipon Pharma Oncology staff on PV best practices and help create SOPs and Work Instructions to underlie them.
  • Other duties as assigned.

Qualifications

  • MD (or ex-US equivalent) or PharmD
  • Minimum of 6-10 years of experience in Pharmacovigilance
  • Oncology PV experience strongly preferred
  • Experience working with vendors strongly preferred
  • Leadership experience including the supervision and mentoring of PV staff
  • 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

Equal Opportunity Employer

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