Job Description

Our client is developing best-in-class therapeutics to treat and potentially cure cancer patients.

This role is pivotal in ensuring that our client remains a leader in patient safety and pharmacovigilance, fostering a culture where safety is integrated into every aspect of our drug development process. Reporting directly to the Chief Medical Officer (CMO), you will be leading and building out the clients PV and risk management function. This includes being responsible for the strategic oversight and execution of all safety and pharmacovigilance activities, ensuring compliance with global regulatory standards.

As the VP, Head of Safety and Pharmacovigilance, you will lead the clients efforts in ensuring the safety of our investigational products. This involves providing strategic medical oversight, managing safety data, and guiding cross-functional collaboration to integrate safety into all phases of our product lifecycle. As our client is building out its PV department anew, you will be responsible for creating and building the Safety and Risk Management function. Your role will include interacting with regulatory authorities, leading the pharmacovigilance team, and overseeing the activities of external safety service providers.

Key Responsibilities

• Lead and build our client'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 our client's 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 our client externally, building relationships with industry leaders and vendors to enhance our safety and pharmacovigilance capabilities.

Key Requirements

• 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.

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