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Vice President, Drug Safety/Risk Management/PV
Description
Vice President, Drug Safety/Risk Management/PV | DC-area Biotech, strong pipeline/marketed product
A growing Biotech company is looking for a Vice President of Drug Safety to lead and build a Drug Safety/Risk Management/Pharmacovigilance function, given multiple expected global launches over the next several years. You will furthermore lead Drug Safety activities for an already approved marketed product. This position will give you the opportunity to report directly to the CMO and manage a team.
Location
Washington DC/Maryland metro area
Responsibilities
- Overall responsibility for the entire Drug Safety/Risk Management/PV department, both US and Global.
- In a hands-on capacity, lead strategy and tactical operations across Drug Safety disciplines while hiring/building out specific functions as needed.
- Extensive interaction and collaboration across the organization and with other executives.
- Work closely with Clinical Development colleagues/peers in developing/designing BLA submission strategy and subsequent product launch(s).
- Manage the Risk Management and Safety Signaling strategy and implementation across the pipeline.
- Manage a team of direct reports across the Safety function to include PV Ops.
Qualifications / Requirements
- Medical Degree and US Board Certification is required.
- 15+ years of experience focused in Drug Safety/Risk Management/Pharmacovigilance, ideally to include global experience.
- Experience working in a smaller environment and/or building a Drug Safety team is desired.
- Therapeutic Area experience in Oncology and/or Immunology is required.
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