Executive Director, Pharmacovigilance

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

📋 Description

• Lead and implement all pharmacovigilance initiatives for Phase 3 and registration biologics programs.

• Ensure adherence to ICH, FDA, EMA, and other relevant regional regulations.

• Supervise global signal detection, evaluation, management, MedDRA coding reviews, and updates to benefit-risk assessments.

• Manage the workflows for safety data receipt, processing, and reporting in collaboration with CROs, data management, and clinical operations.

• Act as the subject-matter expert and primary pharmacovigilance contact for clinical, regulatory affairs, and medical affairs teams.

• Maintain and enforce the global safety database and infrastructure for adverse event reporting.

• Oversee vendor partnerships and pharmacovigilance service collaborations.

• Author or supervise the creation of Integrated Safety Summaries (ISS) and Integrated Summaries of Efficacy (ISE) for BLA and MAA submissions.

• Oversee the complete safety labeling strategy for biologics.

• Lead the safety sections of Clinical Study Reports, including narratives, adverse event tabulations, and laboratory data analyses.

• Prepare and manage Periodic Safety Update Reports (PSURs), Pharmacovigilance Benefit-Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs).

• Develop Risk Management Plans and Risk Evaluation and Mitigation Strategies.

• Address safety inquiries from health authorities during regulatory evaluations.

• Design and implement structured pharmacovigilance surveillance programs and safety monitoring plans.

• Prepare signal assessment reports and escalate findings to the Safety Monitoring Committee or Data Safety Monitoring Board (DSMB).

• Analyze safety trends in collaboration with clinical pharmacology and biostatistics teams.

• Support post-marketing obligations and Phase 4 safety studies.

• Collaborate with Clinical and Regulatory Affairs on global filing strategies and pharmacovigilance regulatory timelines.

• Represent pharmacovigilance in Health Authority meetings and advisory committee preparations.

• Work with Medical Affairs and Commercial teams on labeling modifications and post-approval safety initiatives.

• Build and mentor a small pharmacovigilance team or manage contract resources as the company grows.

• Establish and uphold standard operating procedures (SOPs), work instructions, and quality standards.

• Conduct oversight audits and ensure compliance with Good Pharmacovigilance Practices (GVP).

• Represent pharmacovigilance in the Clinical Development Team and partake in Program Team leadership meetings.

• Travel for team meetings, interactions with health authorities, investigator meetings, and conferences.

⛳️ Requirements

• A Doctor of Medicine (MD) degree from an accredited institution is mandatory.

• Minimum of 12 years of progressive experience in pharmacovigilance within the pharmaceutical or biotech industry.

• At least 5 years in a senior position with direct responsibility for late-phase global biologics pharmacovigilance programs.

• Proven hands-on experience in authoring Integrated Safety Summaries (ISS) submitted in at least one BLA or MAA.

• Extensive experience in writing safety sections of Clinical Study Reports, Development Safety Update Reports (DSURs), and PSURs/PBRERs for biologics in global development.

• In-depth knowledge of ICH guidelines (E2A–E2E, E6, E8, M4E), FDA/CDER, and EMA GVP Module requirements, along with regional pharmacovigilance regulations (EU, US, Japan, and other ICH regions).

• Comprehensive experience with signal detection methodologies, benefit-risk assessment frameworks, and safety narrative writing.

• Proven history of managing CRO/vendor pharmacovigilance relationships and overseeing safety databases (such as Argus, ARISg, or equivalent).

• Experience with BLA or MAA approval processes for biologics.

• Familiarity with rare diseases, orphan drugs, or first-in-class biologic programs.

• Experience in presenting to Health Authorities (FDA, EMA) and participating in Advisory Committee meetings.

• Knowledge of Risk Evaluation and Mitigation Strategies (REMS) design and implementation or EU Risk Management Plan (RMP) preparation.

• Understanding of pharmacoepidemiology methodologies and real-world evidence applications in safety assessment.

• Exceptional scientific and medical writing skills.

• Strong analytical and critical thinking abilities.

• Capability to independently assess complex safety signals and provide evidence-based recommendations.

• Ability to engage with clinical, statistical, and regulatory colleagues at a peer level.

• Excellent project management capabilities.

• Proven leadership and cross-functional collaboration skills.

• Comfortable working within limited infrastructure and accepting high personal accountability.

• Regularly required to walk, stand, and sit.

• Must be able to regularly lift and/or move items weighing up to 10 pounds.

🏝️ Benefits

• Home office working environment.

• Domestic and international business travel (estimated 10–20%).

• Reasonable accommodations in accordance with the Americans with Disabilities Act of 1990.

• Equal employment opportunity protections.

• SMS/text message notifications regarding the job application.