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Senior Medical Director, Pharmacovigilance

Reference Number: 4241
Location: MA

Our client is a leading specialty biopharmaceutical company.  They have asked us to assist them in their search for a Senior Medical Director, Pharmacovigilance.

Major tasks and responsibilities will include:

  • Serves as global lead for the pharmacovigilance and risk management of assigned investigational and/or marketed products.
  • Develops the product safety surveillance strategy for assigned products during all phases of the product life-cycle.
  • Represents Drug Safety and Pharmacovigilance on the product program teams.
  • Maintains current knowledge of therapeutic area diseases, as well as assigned products safety and efficacy profile.
  • Ensures that routine signaling activities assessment and investigations are completed and documented per standard operating procedures (SOPs).
  • Responds to safety-related queries from regulatory authorities, IRBs/ECs.
  • Leads product benefit-risk assessment discussions at Safety Governance Committee, and includes needed actions to update Reference Safety Information or risk minimization actions.
  • Leads Drug Safety and Pharmacovigilance representation for clinical development of the assigned products, including: clinical development plans, protocol development (inclusion/exclusion criteria, collection and monitoring of safety data), statistical analysis and reporting of study data, safety content of IB, Reference Safety Information, ICF, and regulatory filings (ISS, Benefit-Risk, RMP/REMS).
  • The incumbent will be responsible for medical-safety sections of aggregate safety reports (DSUR, PSUR).
  • Conducts medical review of individual case safety reports (ICSRs), including appropriate follow-up requests, as well as the accuracy and timeliness of expedited reports.
  • Assists in the successful implementation, execution and maintenance of safety processes and systems that conform to the company’s business strategy, industry standards and compliance with global regulations. 

We seek candidates with the following qualifications:

  • Medical degree required. MD with PhD and/or MPH highly preferred.
  • Must have a minimum of 10 years of pharmaceutical industry experience in drug safety and/or clinical research/clinical safety.
  • Requires sound clinical acumen and decision-making skills.
  • Extensive early to late stage safety experience highly preferred.
  • Requires the ability to review, synthesize, analyze, and communicate complex safety data and clinical/pharmaceutical information.
  • NDA/MAA filing experience is highly preferred.
  • Requires expertise in international regulations governing drug safety (US and EU) for pre and post-marketing.
  • Must have people management experience, including physicians, and demonstrated leadership and collaborative skills necessary to influence across functions.
  • Prior experience contributing to the development of drug safety highly preferred.

If interested, please email your resume as a Word attachment to us, reference 4241.  No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.