Quality Recruiting. Established Experts.

Head of Drug Safety

Reference Number: 3673
Location: WA

Our client is a biopharmaceutical company.  They have asked us to assist them in their search for a Head of Drug Safety

Major tasks and responsibilities will include:

  • Oversees and leads the company’s global drug safety function and all related processes and activities.
  • Provides oversight of safety and pharmacovigilance activities for products in clinical development and future marketed products.
  • Possess knowledge and understanding of investigational drug pharmacology and chemistry from a safety perspective, relevant nonclinical toxicology, and clinical adverse event profiles in the company’s therapeutic areas of interest.
  • Hires, develops, and mentors an accomplished pharmacovigilance team, and establishes external contractual relationships to ensure implementation of company and quality objectives.
  • Manages all processes and operating procedures to ensure compliance with appropriate safety regulations and quality standards.
  • Ensures drug safety surveillance and other pharmacovigilance activities are in compliance with regulatory requirements and company SOPs.
  • Identifies, assess, and communicates potential safety signals; oversees the generation and analysis of safety data.
  • Collaborates with Regulatory Affairs and Clinical Development to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community.
  • Builds, manages, maintains, and enhances compliance with pharmacovigilance and drug safety SOPs.
  • Oversees and contributes to the preparation of required regulatory dossiers, regulatory safety reports, safety-related investigator communications, product labeling/package inserts, and other reports as required.
  • Provides oversight and key input for review of new or ongoing safety documents that ensure compliance with domestic and international regulatory requirements, such as clinical protocols, safety summaries, regulatory reports, and submissions packages (CTDs, BLAs, etc.).
  • Spearheads efforts to further characterize and describe safety issues or potential safety concerns prior to BLA filings, and foresee and help initiate post marketing opportunities for risk mitigation.
  • Collaborates with medical monitoring professionals and teams that support active clinical trials.
  • Demonstrates leadership by communicating and collaborating effectively across departments to ensure a company culture that is always committed to putting the safety and well-being of patients first.
  • Serves as the company’s pharmacovigilance and drug safety subject matter expert in internal and external meetings, including interactions with regulatory agencies.

We seek candidates with the following qualifications:

  • An advanced medical degree (MD, DO, or equivalent) is preferred.
  • Must have a proven track record of industry pharmacovigilance experience.
  • Prior experience with therapeutic biologics is required.
  • Must have prior experience leading teams.
  • Must have prior experience with NDA/BLA submissions and new product launch.
  • Requires expertise in regulatory requirements and guidelines pertaining to drug safety and risk management.
  • Must have experience with developing, implementing, and measuring the impact of pharmacovigilance processes and systems across multiple projects.
  • Requires proven excellence in operational strategy.
  • Must have the ability to work within a matrixed team environment.
  • Must have the ability to interpret, communicate, and present clinical, scientific, and medical information in a clear and concise manner.
  • Must have demonstrated the ability to proactively and effectively influence peers and external colleagues across all levels of management.
  • Requires proven negotiation skills.
  • Must possess a work style that is goal-driven, results-oriented, and committed to high quality.


If interested, please email your resume as a Word attachment to us, reference 3673.  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.