Senior Medical Director, Safety & Risk Management

Our client is a biotechnology company. They have asked us to assist them in a search for a Senior Medical Director, Safety & Risk Management.    

Major tasks and responsibilities include:
  • Oversees members of the Safety Evaluation and Risk Management group.
  • Represents global safety risk management in clinical sub teams for investigational products and provides medical guidance regarding safety matters and challenges.
  • Oversees the safety management team for assigned pre-marketing and post-marketing products and all related risk management activities.
  • Plays an active role in the signal management system and regularly reviews safety data for assigned products to identify and evaluate new safety signals.
  • Oversees medical reviews of individual safety reports from clinical trials and post-marketing sources.
  • Prepares and reviews periodic reports (PADER; PSUR; Annual IND report; 6-monthly line-listings; EU Annual Safety Report; DSUR).
  • Participates in protocol development to ensure alignment with risk management plans.
  • Reviews and provides medical content for key related documents.
  • Contributes to the analysis of safety data from ongoing and completed clinical trials and presentations in clinical study reports.
  • Facilitates production and maintenance of risk management plans and safety communication regulatory agencies or third parties.
  • Participates in continuous improvement activities including systems design, performance measurement and quality management.
  • Guides staff on pharmacovigilance and risk management practices as well as safety science.
  • Provides input to pharmacovigilance agreements and interactions.
  • Participates in alliance safety teams with external partners.

We seek candidates with the following qualifications:
  • A Medical Degree is required (board certified or ex-US equivalent).
  • Must have a minimum of 3 years of experience as a director in drug safety, clinical safety, pharmacovigilance or risk management.
  • Oncology safety science experience is preferred.
  • Knowledge of ICH, US & EU regulations and requirements for pharmacovigilance is required.
  • Must have experience with global safety reporting regulations and guidelines.
  • Requires excellent interpersonal skills, including the ability to work effectively cross culturally and cross functionally.
  • Excellent written and spoken English is required.
  • Prior experience with business partners is a plus.

If interested, please apply directly to this job posting. No calls 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 and Forbes' list of Top 200 Best Executive Recruiting Firms.
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