Senior Director, Drug Safety & Pharmacovigilance Operations

Role Summary

The Senior Director of Drug Safety & Pharmacovigilance Operations will lead Kymera’s safety surveillance, ensuring robust safety monitoring, compliance, and operational excellence across all programs. This leader will oversee safety vendor performance, shape the company’s safety governance framework, and support strategic decisions across development and regulatory interactions. The Senior Director reports to the Vice President, Head of Drug Safety and Pharmacovigilance.

Responsibilities

• Provide strategic leadership for global pharmacovigilance operations, including case management, vendor oversight, and aggregate reporting.
• Lead and mentor a growing PV team, fostering a culture of scientific rigor, compliance, and collaboration.
• Serve as the operational owner for global safety systems, ensuring accurate, timely data capture and reporting in accordance with ICH, FDA, EMA, MHRA, and other regulatory requirements.
• Oversee vendor selection and management for PV activities (e.g., safety database hosting, ICSR processing & review, regulatory submissions).
• Oversees PV vendor(s) performance and compliance via monitoring Key Performance Indicators (KPIs) and metrics, periodic governance meetings, and implementation of effective Corrective and Preventative Action plans.
• Partner cross-functionally with Clinical Development, Regulatory Affairs, Quality, and Medical Affairs to ensure safety operational strategies are integrated across all development programs.
• Collaborate with medical safety and cross functionally to facilitate signal and risk management activities, including internal safety committee meetings.
• Lead inspection readiness and interactions with global health authorities for safety-related audits or inquiries.
• Develop and implement standard operating procedures (SOPs), safety management plans (SMPs), and safety agreements with partners and CROs.
• Collaborates with Data Management and the PV vendor in the reconciliation of adverse events between the clinical and safety databases and issue queries. Develop safety reconciliation plans.
• Provide operational oversight for preparation and submission of aggregate safety reports (e.g. DSUR), safety data collection, literature reviews, regulatory responses, and clinical trial application submissions.
• Oversees review and archive of PV-related records in various documentation management systems (e.g. TMF, PSMF).
• Contribute to long-term organizational strategy and capability building within Drug Safety and Pharmacovigilance.

Qualifications

• Minimum 8-10 years of pharmacovigilance experience within the biopharmaceutical industry, including at least 2 years in a senior leadership role.
• Demonstrated expertise in global PV regulations, GVP and ICH guidelines, safety systems, and drug development processes.
• Experience in PV processes for vendor oversight, individual case handling, signal management, aggregate data review, aggregate reports, and audits/inspections.
• Proven track record managing vendors and building internal PV capabilities in a fast-paced, innovative environment.
• Exceptional communication and cross-functional collaboration skills.
• Strategic thinker with the ability to translate complex safety data into actionable insights for regulatory and clinical decision-making.

Education

• Health care professional degree (e.g. RN, PharmD) or advanced degree (Masters/PhD) in biomedical sciences, pharmaceutical sciences, or related life science discipline is preferred.