Senior Director, Global Patient Safety Operations

The Opportunity:

We are seeking a highly skilled and experienced Senior Director of Global Patient Safety Operations to join our team. Reporting to the Head of Global Patient Safety Operations, this role is a senior operational leader accountable for translating the department’s strategy into scalable, compliant, and inspection-ready pharmacovigilance operations. The Senior Director will provide broad oversight across case processing, vendor governance, safety systems and processes, aggregate reporting operations, partner interfaces, and operational readiness while developing leaders and serving as a key advisor to cross-functional stakeholders.

The successful candidate will draw upon their experience to:

• Provide strategic and operational leadership for Global Patient Safety Operations, translating functional priorities into executable plans, governance, metrics, resource models, and continuous improvement initiatives.

• Lead, coach, and develop managers and individual contributors; establish clear accountabilities, succession plans, and an inclusive, high-performing team culture.

• Oversee end-to-end Individual Case Safety Report operations from all sources, ensuring quality, timeliness, compliance with global reporting requirements, effective deviation and late-case management, and meaningful trend analysis.

• Own governance of pharmacovigilance vendors and CROs, including selection support, contracts and scope, service-level expectations, quality and compliance metrics, issue escalation, capacity planning, budget oversight, and business continuity.

• Guide development, validation, configuration, and ongoing optimization of the global safety database and related technology, ensuring the operating model and system controls remain fit for purpose as the portfolio evolves.

• Direct development and maintenance of the pharmacovigilance system and supporting processes, including SOPs, work instructions, the Pharmacovigilance System Master File, training, inspection readiness, and corrective and preventive actions.

• Partner with cross-functional teams and support accurate and timely operational delivery of expedited and periodic safety reports, including DSURs and PBRERs, and support preparation of aggregate safety analyses, REMS/RMP deliverables, and health-authority responses.

• Partner with Safety Science and Clinical Development on case review workflows, narratives, causality assessments, analyses of similar events, individual case comments, and other safety evaluations as needed.

• Provide senior-level review and input for safety-related regulatory reports and clinical study documents, including protocols, case report forms, informed consent forms, Investigator Brochures, ISS/ISE documents, labeling, and Company Core Safety Information, as applicable.

• Lead cross-functional operational interfaces with Clinical Operations, Clinical Development, Clinical Data Science, Regulatory Affairs, Quality Assurance, Medical Affairs, Information Technology, and other functions to resolve complex issues and strengthen end-to-end processes.

• Oversee clinical-to-safety database reconciliation and other data quality controls, ensuring issues are investigated, documented, trended, and remediated.

• Partner with the EU QPPV and relevant stakeholders to support European pharmacovigilance compliance and maintain pharmacovigilance agreements and safety data exchange agreements with partners.

• Lead or play a central role in health-authority inspections, audits, and due diligence activities; ensure commitments and remediation plans are completed on time and remain sustainable.

• Represent Global Patient Safety Operations in governance forums and cross-functional leadership discussions, communicate risks and options clearly, and deputize for the Head of Global Patient Safety Operations as appropriate.

Required Skills, Experience and Education: