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Senior Vice President, Pharmacovigilance
2 months ago
Overview
A prominent Biotech organization is seeking a Vice President of Drug Safety to spearhead and develop a comprehensive Drug Safety/Risk Management/Pharmacovigilance division, in anticipation of several global product launches in the near future. This role also encompasses overseeing Drug Safety initiatives for an existing marketed product. The position offers a unique opportunity to report directly to the Chief Medical Officer and to lead a dedicated team.
LocationWashington DC/Maryland metro area
Key Responsibilities- Assume overall accountability for the Drug Safety/Risk Management/PV department on both a national and international scale.
- In a proactive manner, direct strategic and operational activities across Drug Safety domains while recruiting and establishing specific functions as necessary.
- Engage extensively with various departments and collaborate with other senior executives.
- Partner closely with Clinical Development teams to formulate and design strategies for BLA submissions and subsequent product launches.
- Oversee the Risk Management and Safety Signaling strategies and their execution across the product pipeline.
- Lead a team of direct reports within the Safety division, including Pharmacovigilance Operations.
- A Medical Degree along with US Board Certification is mandatory.
- 15+ years of specialized experience in Drug Safety/Risk Management/Pharmacovigilance, with a preference for global exposure.
- Experience in a smaller organizational setting and/or in establishing a Drug Safety team is advantageous.
- Experience in therapeutic areas such as Oncology and/or Immunology is essential.
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