Senior Director, Medical Safety & Pharmacovigilance

Responsibilities

• Provide strategic and medical leadership for global safety surveillance and risk management activities across all investigational and, as applicable, marketed products, ensuring proactive benefit-risk assessment throughout the product lifecycle.
• Lead the development, implementation, and continuous improvement of pharmacovigilance policies, procedures, and safety governance processes that support regulatory compliance and operational excellence.
• Ensure compliance with global pharmacovigilance regulations and reporting requirements, including FDA, EMA, ICH, and other applicable health authority standards.
• Serve as the medical lead for signal detection and signal management activities, including identification, evaluation, interpretation, and communication of emerging safety signals through review of individual case reports, aggregate safety data, clinical trial data, literature, and external sources.
• Conduct and oversee medical review of serious adverse events, adverse events of special interest, and individual case safety reports to ensure accurate medical assessment and regulatory reporting.
• Chair and lead Safety Management Team (SMT) meetings and other safety governance forums, driving timely safety decision-making and escalation of significant safety issues.
• Author, review, and approve safety assessments, benefit-risk evaluations, signal evaluation reports, and safety recommendations for internal stakeholders, regulatory authorities, and external partners.
• Provide strategic leadership and oversight for the preparation and review of aggregate safety reports and regulatory safety submissions, including DSURs, PBRERs/PSURs, IND annual reports, expedited safety reports, integrated summaries of safety, and marketing application documents.
• Direct the development and maintenance of core safety documents, including Investigator Brochures, Reference Safety Information (RSI), Company Core Data Sheets (CCDS), Safety Management Plans, and Risk Management Plans, as applicable.
• Partner closely with Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, Quality, and Clinical Operations to integrate safety perspectives into development strategy and regulatory interactions.
• Collaborate with alliance partners, licensors, CROs, and external vendors on pharmacovigilance operations, safety monitoring, signal management activities, and safety data exchange agreements.
• Represent Drug Safety and Pharmacovigilance in cross-functional governance committees, development teams, due diligence evaluations, and interactions with regulatory authorities.
• Build, develop, and mentor a high-performing team of pharmacovigilance physicians and safety professionals, fostering scientific excellence, accountability, and career growth.
• Ensure inspection readiness and maintain a state of compliance for all pharmacovigilance activities; actively support health authority inspections, partner audits, and internal quality assessments.
• Monitor and interpret emerging regulatory requirements, industry trends, and evolving best practices in pharmacovigilance, risk management, and signal detection, translating them into organizational strategies and processes.
• Review and evaluate relevant scientific and medical literature to support ongoing safety assessments and benefit-risk evaluations.
• Contribute to corporate development activities, including due diligence assessments, asset evaluations, and integration planning for business development opportunities, as needed.

Qualifications

• MD, MD PHD, or MD MPH required
• 12+ years pharmaceutical industry experience in pharmaceutical drug development, including significant experience in pharmacovigilance and drug safety leadership.
• Deep understanding of global pharmacovigilance regulations, including FDA, EMA, ICH, and other regional requirements.
• Demonstrated experience leading safety surveillance, signal detection, risk management, and aggregate reporting activities for investigational and/or marketed products.
• Strong scientific and clinical judgment with the ability to evaluate complex safety data and communicate benefit-risk assessments effectively.
• Proven leadership experience managing teams and influencing cross-functional stakeholders in a matrix environment.
• Excellent written and verbal communication skills with experience presenting to senior leadership, governance committees, regulators, and external partners.