Senior Director, Safety Evaluation and Risk Management

West Coast
Our client is a biotechnology company. They have asked us to assist them in a search for a Senior Director, Safety Evaluation and Risk Management.  

Major tasks and responsibilities include:
  • Directs the Safety Evaluation and Risk Management team in Safety Risk Management on a global scale.
  • Acts as the face of Global Safety Risk Management in Clinical Sub Teams for assigned investigational products and provides expert medical guidance regarding safety matters.
  • Oversees Safety Management Team for assigned pre-marketing and post-marketing products and all associated risk management activities.
  • Participates in the Signal Management System and regularly reviews safety data for assigned products for identification and evaluation of new safety signals.
  • Holds responsibility for the medical review of individual safety reports from clinical trials or post-marketing sources.
  • Prepares and reviews periodic reports.
  • Participates in protocol development to ensure alignment with risk management plans.
  • Reviews and provides medical content, as needed, for key study-related documents.
  • Contributes to analysis of safety data from on-going and completed clinical trials and presentation in Clinical Study Reports.
  • Facilitates production and maintenance of risk management plans and safety communication.
  • Participates in continuous improvement activities including systems design, performance measurement and quality management.
  • Mentors team on safety science and risk management standards and protocols.
  • Participates in alliance safety teams with external parties.
We seek candidates with the following qualifications:
  • An MD from an accredited institution (board certified or ex-US equivalent) is required.
  • Requires a minimum of 3 years of management experience in Drug Safety, Clinical Safety, and Pharmacovigilance.
  • Experience with oncology safety science is preferred.
  • Knowledge of ICH, US & EU regulations and requirements for pharmacovigilance is required.
  • Requires experience with world-wide safety reporting regulations and guidelines. ‘
  • Must have excellent interpersonal skills, as well as the ability to work effectively cross culturally and cross functionally.
  • Excellent written and spoken English skills are 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.
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