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.
We seek candidates with the following qualifications:
- Provides input to pharmacovigilance agreements and interactions.
- Participates in alliance safety teams with external partners.
- 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.
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