Associate Director, Pharmacovigilance Operations

Overview of Role:

We are seeking an experienced and strategic Associate Director of Pharmacovigilance Operations to support our global PV operational infrastructure. This role is accountable for the oversight of all outsourced safety operations, vendor governance, and operational compliance across clinical and/or post-market settings. The Associate Director, PV Operations will play a critical role in scaling PV operations capabilities, ensuring inspection readiness, regulatory compliance, and contributing to strategic safety planning. The ideal candidate has experience supporting both clinical and post-market programs and can lead vendor governance, inspection readiness, and PV systems management.

This role will support the PSPV department and report to the Executive Director, PV Operations and Compliance. Key responsibilities of the role include, but are not limited to:

Role and Responsibilities:

• Oversee the process for ICSR collection, processing, reconciliation, and reporting, including associated quality activities to ensure regulatory timelines and global standards are met.
• Provide oversight and support of the PV vendor activities, including establishing and monitoring key performance indicators (KPIs), always ensuring inspection-readiness.
• Oversee global compliance with pharmacovigilance regulations, including timely ICSR submissions, quality case processing, and aggregate reporting support.
• Identify and support the development of PV operational SOPs, work instructions, and guidance documents.
• Identify and support in the development and maintenance of Safety Management Plans (SMPs) and Pharmacovigilance Agreements (PVAs)/Safety Data Exchange Agreements (SDEAs), with license partners and/or other parties.
• Oversee reconciliation activities between safety and clinical databases, as well as case exchanges from business partner, specialty pharmacy, etc.
• Oversee safety database configuration and maintenance, as required.
• Support PV audit and inspection activities, as required, and serve as SME during these activities.
• Support and oversee deviation and Corrective and Preventive Action (CAPA) activities related to, but not limited to, expedited and periodic reporting activities, deviations related to case management processes, as defined in the SMPs or SOPs, and PVA/SDEA compliance.
• Collaborate with cross-functional teams, such as Clinical Operations, and Regulatory to ensure safety report submissions to sites, ethics committees, regulatory agencies, business partners, etc.
• Assist with PV Operational processes and initiatives, representing PV Operations in collaboration with other functions as needed.
• Work cross-functionally with Regulatory Affairs, Clinical Operations, Clinical Development, Data Management, Quality Assurance, Commercial, and Medical Affairs to ensure appropriate PV processes are in place and adhered to.
• Serves as key point of contact between PV Operations and the CROs regarding PV operation management.
• Provide PV operational expertise in development of RMPs, REMS, DSURs, PSURs, and other safety deliverables.
• Represent PV operations in internal safety governance forums and external collaborations/partnerships
• Participate in cross-functional monitoring of study data, as necessary.
• Assist in the development, review and management of departmental budget, MSAs, SOWs, invoices and payment of work performed by vendors.
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Degree in Life Sciences, Pharmacy, Nursing or related field
• Minimum of 10+ years of experience in PV in Biotech, Pharma or a CRO.
• Hands-on experience in vendor oversight, including governance, ensuring adherence to KPIs, and managing PVAs/SDEAs.
• Prior experience working within a Safety Database (Argus, ARISg, etc.).
• Prior experience in Clinical and Post-Market Safety and Risk Management with an understanding of the various stages of the product life cycle.
• Experience working in a matrixed and fast-paced environment and able to manage multiple projects with an ability to creatively resolve issues and mitigate risks.
• Ability to translate PV knowledge and expertise into action.
• Demonstrated ability to monitor multiple projects, and actively track timelines.
• Strong understanding of global PV regulatory requirements and timelines (e.g. FDA, EMA, MHRA, PMDA, E2B R3, etc) and PV Systems (e.g. Argus, Arisglobal, Vault Safety).
• Experience working with management and cross-functional stakeholders (e.g., Clinical, Regulatory, Quality), including an ability to influence without authority.
• Effective collaboration and interpersonal skills.
• Ability to work independently, establish work priorities, and execute decisions with minimal guidance.
• Ability to interpret related regulatory guidance and problem-solve towards a compliant approach with a background and understanding of industry best practices.
• Excellent decision-making and analytical skills.