VP – Head of Safety and Pharmacovigilance
VP – Head of Safety and Pharmacovigilance
Merus is seeking an innovative and collaborative leader to join our team as the Vice President, Head of Safety and Pharmacovigilance.
The Role
Key Responsibilities:
- Lead and build Merus’s PV and Risk Management function
- Establish and maintain a safety and pharmacovigilance infrastructure that prioritizes “safety by design” in all development activities.
- Lead all pharmacovigilance and risk management activities for Merus products, including safety surveillance, signal detection, and risk-benefit assessments.
- Serve as the primary contact for safety-related issues, including regulatory authority interactions and safety service provider management.
- Provide strategic safety insights to the CMO and Executive Leadership Team, particularly regarding the risk-benefit profile of company products.
- Oversee the preparation and review of safety documents, including DSURs, safety reports, and clinical development documentation.
- Ensure compliance with global safety regulations and guidelines, and lead responses to safety-related inquiries from regulatory authorities.
- Manage the pharmacovigilance budget and resources, including both internal teams and external contractors.
- Drive continuous improvement in pharmacovigilance practices, ensuring readiness for regulatory inspections and audits.
- Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, and Quality, to integrate safety considerations into company strategy.
- Represent Merus externally, building relationships with industry leaders and vendors to enhance our safety and pharmacovigilance capabilities.
Your Profile
Qualifications:
- M.D., D.O., or M.B.B.S. required.
- Minimum of 10 years of global experience in drug safety within the biotechnology or pharmaceutical industry.
- In-depth knowledge of FDA safety regulations, ICH Guidelines, EU GVP, and other global safety regulations.
- Deep understanding of risks and risk mitigation steps related to safety signals and pharmacovigilance
- Expert knowledge of safety database applications (e.g., ARGUS, ARISg) and safety signal detection.
- Strong leadership skills with the ability to mentor teams and lead cross-functional initiatives.
- Excellent written, verbal, and presentation skills, with the ability to influence senior leadership and external stakeholders.
Why Merus?
Apply now
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