Position Summary:

This position is responsible for creating, directing, and managing the company’s infrastructure and staff to support the operational aspects of the pharmacovigilance operations and compliance system to adhere to all global regulatory requirements and internal processes and procedures. The qualified candidate will have experience in and perform multiple activities related to overall safety operations strategy across the portfolio, including oversight of case management, database strategy, vendor oversight, compliance, inspection readiness, contracts, departmental strategy and training. In addition, this position must build and maintain relationships with key strategic internal and external stakeholders, including the hiring and development of Drug Safety and Pharmacovigilance (DSPV) personnel. As a member of the DSPV leadership team, this role partners closely with the Head of DSPV to shape PV Operations strategy, own budget and resourcing decisions, and represent DSPV Operations to senior leadership and external partners.

Responsibilities:

• Own and drive global PV Operations strategy, including planning, implementation, and management, in the US and globally internationally, in close alignment with the Head of DSPV on portfolio-level risk, resourcing, and business priorities.
• Serve as a key advisor to the Head of DSPV on operational risk, resource allocation, and DSPV budget planning; own accountability for the DSPV Operations budget, including CRO and vendor contract spend.
• Represent DSPV Operations in interactions with senior leadership and, as needed, and support due diligence activities (e.g., licensing, partnerships, M&A).
• Manage internal and external staff allocated to operational PV activities, creating a highly efficient team.
• Own talent strategy for PV Operations, including hiring, development, performance management, and succession planning.
• Provide expert guidance and leadership both internally and externally based on in-depth knowledge of development and post-marketing safety requirements, per ICH, US and international regulations and guidelines, and Good Pharmacovigilance Practice.
• Build and implement pharmacovigilance systems that are fully compliant with the applicable worldwide Health Authority PV regulations.
• Provide oversight of systems and MedDRA updates in collaboration with the relevant PV vendor.
• Contribute to the selection of PV vendors to support an outsourced PV business model. Provide vendor oversight and management for all outsourced or insourced PV activities, including establishing and monitoring key quality and compliance metrics, invoicing and budgetary needs related to operations and compliance.
• Develop and implement an inspection readiness program with the contribution of other PV and non-PV stakeholders.
• Serve as the PV Operations lead/host during Health Authority inspections and audits (e.g., FDA, EMA, MHRA), coordinating responses and remediation.
• Responsible for a compliant and quality execution of all operational activities related to case management and related activities. Oversee timely submissions of expedited reports to the FDA and other health authorities in conjunction with Regulatory.
• Establish a system for identifying, preventing, and correcting compliance deviation, including applicable corrective and preventive actions, in collaboration with the Quality group and internal/external stakeholders, to maintain reporting compliance at the highest level.
• Oversee the setup of new safety projects, including development of study-specific Safety Management Plans and setup of safety systems and database configurations in the PV database to accommodate these trials and products.
• Contribute to, draft, and implement department SOPs and work instructions related to the PV activities.
• Contribute to the signal detection, benefit-risk profile assessment, and aggregate reporting activities with providing accurate reports from the safety database.
• Effectively collaborate with key stakeholders at all levels in the organization, including Clinical Operations, Clinical Development, Regulatory Affairs, Legal, Medical Affairs, and Manufacturing to develop compliant procedures in line with industry standards and best practices.
• Represent PV Operations as a leader on project teams, cross-functional committees, and governance bodies (e.g., Safety Management Team), providing operational input to signal review and safety governance processes.
• Elevate a quality mindset across DSPV.
• Lead training activities, including setting training requirements and training compliance.
• Build and oversee PV regulatory intelligence activities.

Qualifications:

• Healthcare or life sciences degree required; advanced degree (e.g., PharmD, RN, MPH, or scientific PhD) preferred.
• 15+ years of pharmacovigilance experience, including 5+ years in a people-leadership role managing global PV teams.
• Experience with clinical and commercial lifecycle phases is required.
• Demonstrated experience managing PV Operations through multiple Health Authority inspections (e.g., FDA, EMA, MHRA).
• Experience spanning both clinical-stage and commercial/post-marketing environments, ideally across multiple therapeutic areas.
• Skilled in process gap assessments and process enhancements.
• Strategic thinker.
• Strong execution and drive for results skills.
• Comfortable working independently.
• Deep knowledge of pharmacovigilance regulations and guidelines.