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Senior Medical Director, Pharmacovigilance

Reference Number: 3763
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:

  • Establishes and implements pharmacovigilance strategy to file the first of several NDAs and prepare the company for their first product launch.
  • This is a highly visible role that will interface across all levels of management and functional areas.
  • Acts as the global lead for the risk management and pharmacovigilance of assigned marketed and/or investigational products.
  • Identifies safety signals and signal investigation.
  • Proactively manages the benefit-risk profile for assigned products.
  • Leads product safety surveillance activities for assigned late stage portfolio.
  • Maintains knowledge of therapeutic area diseases and assigned product(s) safety and efficacy profile.
  • Ensures that routine signaling activities assessment and investigation are completed and documented per SOPs.
  • Respond to safety-related queries from regulatory authorities, IRBs/ECs.
  • Leads product benefit-risk assessment discussions at Safety Governance Committee.
  • Leads DS&PV representation for clinical development of the assigned product(s).
  • Conducts medical review of individual case safety reports.

We seek candidates with the following qualifications:

  • MD required.
  • Must have significant pharmaceutical industry experience drug safety and/or clinical research/clinical safety.
  • Requires sound clinical acumen and decision making.
  • Must be able to review, synthesize, analyze, and communicate (verbally and in writing) complex safety data and clinical/pharmaceutical information.
  • Requires expertise in international regulations governing drug safety (US and EU) for pre and post-marketing.
  • Must have demonstrated leadership and collaborative skills necessary to influence across functions.
  • Prior experience contributing to the development of drug safety high preferred.

If interested, please email your resume as a Word attachment to us, reference 3763.  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.