Senior Executive Director, Pharmacovigilance

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

📋 Description

• Act as the Head of Pharmacovigilance, responsible for safety strategy, safety science, and pharmacovigilance operations throughout the portfolio.

• Report directly to the Chief Medical Officer.

• Develop a purpose-built, inspection-ready pharmacovigilance function that scales with the global Phase 3 development of JADE101 and the early development of JADE201/JADE301.

• Create frameworks for safety governance and signal management.

• Supervise outsourced pharmacovigilance vendors and either author or review critical safety deliverables.

• Collaborate with Clinical Development, Regulatory Affairs, Clinical Operations, Biometrics, Quality, and Program Management.

• Ensure timely and compliant expedited and periodic reporting, including SUSARs, IND safety reports, and DSURs, to the FDA, EMA, and other health authorities.

• Author or provide senior review of safety documentation for protocols, Investigator’s Brochures, informed consent forms, clinical study reports, and responses to health authorities.

• Support global expansion efforts, including regulatory interactions in Japan and China and multi-region Phase 3 execution.

• Oversee the management of safety databases, case processing, reconciliation, literature screening, and submissions.

• Manage vendor KPIs, quality metrics, pharmacovigilance budget, and resourcing model.

• Negotiate and implement safety data exchange agreements with partners, licensors, and CROs.

• Develop and maintain pharmacovigilance quality systems, SOPs, work instructions, training curricula, and the pharmacovigilance system master file.

• Ensure compliance with GVP/GCP and lead pharmacovigilance inspection and audit-readiness activities in collaboration with Quality Assurance.

• Identify and address process gaps during the transition from early-stage to late-stage development.

• Recruit, mentor, and develop pharmacovigilance staff and consultants; establish scalable processes and foster a culture of scientific rigor and accountability.

⛳️ Requirements

• Bachelor’s degree with 10–15 years of experience in the industry.

• At least 10 years of experience in pharmacovigilance/drug safety within the biopharmaceutical industry.

• Progressive leadership responsibilities; Executive Director level requires a broader scope and prior head-of-function experience.

• Proven experience as head of pharmacovigilance or as a deputy in a development-stage company.

• Experience in building tailored pharmacovigilance processes and quality systems.

• Extensive knowledge of global pharmacovigilance regulations and guidance, including 21 CFR, ICH E2A/E2B/E2C/E2D/E2F, and EU GVP modules.

• Familiarity with expedited and aggregate reporting requirements.

• Experience in selecting and supervising pharmacovigilance vendors, safety databases such as Argus, and outsourced case processing operations.

• Experience in supporting FDA and/or EMA health authority inspections and client/sponsor audits with successful outcomes.

• Exceptional scientific judgment, written and verbal communication, and cross-functional collaboration skills.

• Preferred: 10 years of experience with biologics/monoclonal antibodies and in fields such as immunology, rheumatology, nephrology, or rare disease programs.

• Preferred: Experience in supporting late-stage global development and BLA/MAA safety deliverables, including risk management plans.

• Preferred: Familiarity with safety data visualization and analytics tools for signal detection.

• Preferred: Experience in integrating pharmacovigilance requirements across licensing and partnering relationships.

• Preferred: Prior experience in scaling a pharmacovigilance function from first-in-human through Phase 3 and towards marketing authorization.

• Authorization to work in the United States as verified through I-9 and E-Verify.

🏝️ Benefits

• Remote work arrangement.

• Periodic travel to team and company events.