Overview In this role you lead pharmacovigilance operations to ensure compliant, efficient handling of safety data and collaborative governance across PV, Medical, Clinical, Regulatory, Quality, and Commercial teams. You oversee vendor performance, inspection readiness, and risk remediation, shaping how we manage safety signals and regulatory obligations. You will drive cross-functional processes, maintain governance documentation, and partner with senior leadership to address strategic safety and compliance issues. This is a leadership position with a strong focus on process optimization, vendor oversight, and a culture of patient safety.
Responsibilities- Coordinate pharmacovigilance operational processes (adverse event intake, case processing, regulatory reporting, literature surveillance, reconciliations, aggregate reporting support, safety data exchange).
- Ensure effective interfaces between PV and other functions (Medical, Clinical, Regulatory, Quality, Commercial).
- Monitor activities, due dates, dependencies; escalate delays, risks, or resource constraints.
- Oversee product/partner/study/program PV requirements within the PV system; support governance information.
- Maintain PV governance and inspection readiness documentation and metrics.
- Oversee vendor/external party onboarding, governance, performance reviews, and offboarding; manage expectations and evidence.
- Prepare for regulatory inspections and partner/audit activities; coordinate evidence, narratives, and demonstrations.
- Coordinate PV SOPs, training, templates, and governance tools; ensure training completion and gap closure.
- Support safety governance, risk minimization actions, and escalation of safety issues to senior leadership.
- Provide leadership to PV personnel; promote cross-functional collaboration, accountability, and continuous improvement.
Key requirements- Strong working knowledge of US and global PV requirements for clinical development and marketed products.
- Experience with ICSR management, regulatory reporting, literature surveillance, aggregate reporting, reconciliations, and safety data exchange.
- Ability to oversee outsourced or delegated PV activities and vendor governance.
- Experience establishing/performance metrics, governance actions, and escalation pathways.
- Knowledge of deviations, investigations, CAPAs, change controls, audits, inspections, and inspection readiness.
- Ability to interpret PV agreements, service agreements, and statements of work; translate into operational oversight.
- Excellent documentation, organization, issue management, and evidence retrieval skills.
- Strong communication and influencing skills in cross-functional/vendor environments.
- Ability to manage multiple priorities in a regulated, fast-paced setting.
- Cross-functional collaboration
- Clear communication
- Leadership and people-management
- ICSR management
- Regulatory reporting
- Literature surveillance
