Vice President, Pharmacovigilance

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and manage a comprehensive pharmacovigilance strategy and operations focused on ensuring patient safety.

• Create and execute pharmacovigilance processes, policies, standard operating procedures (SOPs), and safety database/pharmacovigilance systems.

• Direct cross-functional governance, benefit-risk assessments, signal detection, and risk management activities.

• Chair the executive safety review committee.

• Supervise the exchange of safety data with partners and contribute to safety initiatives across the industry.

• Collaborate with clinical development teams to embed safety considerations into protocols, risk management plans, and safety charters.

• Provide pharmacovigilance oversight for IND/BLA/MAA regulatory submissions, including Clinical Overviews, Integrated Safety Summaries (ISS), and Risk Management Plans (RMPs).

• Review Investigator Brochures (IBs), Development Safety Update Reports (DSURs), and critical sections of Clinical Study Reports (CSRs), participating in regulatory meetings as required.

• Lead the medical review of Individual Case Safety Reports (ICSRs) and oversee the operations, quality, and compliance of the pharmacovigilance team.

• Monitor and evaluate the performance of Contract Research Organizations (CROs) involved in pharmacovigilance activities.

• Recruit, hire, train, mentor, and develop pharmacovigilance staff.

• Manage project deliverables and conduct performance evaluations.

⛳️ Requirements

• Medical Doctor (MD) with clinical and industry experience.

• Demonstrated success in leading pharmacovigilance teams.

• At least 15 years of experience in drug safety and pharmacovigilance within the biotech or pharmaceutical sectors.

• Proven leadership capabilities, including the ability to build and manage high-performing teams.

• Extensive knowledge of global pharmacovigilance regulations and compliance standards (EMA/FDA/ICH).

• Strong leadership skills and strategic decision-making capabilities.

• Authorization to work in the US is required in the application form.

🏝️ Benefits

• Equity

• Bonus

• Commitment to an equal opportunity employer that promotes a diverse, inclusive, and equitable workplace.