Senior Manager, Pharmacovigilance Operations

Brief Description:

The Senior Manager, Pharmacovigilance (PV) Operations provides operational leadership and leads execution of global PV operational activities across clinical trial and postmarketing programs. The role owns and provides support for safety database configuration, regulatory intelligence implementation, vendor performance, and operational readiness to lead global product launches and country expansion, while ensuring compliant, highquality, and inspectionready PV operations.

Essential Functions/Responsibilities

• Lead and drive execution of global pharmacovigilance operational activities across clinical trial and postmarketing programs.
• Drive PV operational readiness for global product launches and new market expansions.
• Serve as a recognized PV Operations subject matter expert (SME) providing operational guidance in crossfunctional initiatives.
• Ensure and continuously monitor PV operations for compliance, consistency and inspection readiness.
• Manage safety reporting activities across the portfolio, including devicerelated safety events (e.g., SADEs, malfunctions) and compliance with Medical Device Reporting (MDR) and In Vitro diagnostic Regulation (IVDR) requirements, in compliance with applicable global regulations.
• Provide functional leadership and direction to vendors, CROs, and cross-functional partners.

Regulatory Intelligence & Country Expansion

• Monitor, interpret, and apply regulatory intelligence for new and existing markets to identify PV obligations, including ICSR reporting requirements, data retention expectations, and local authority requirements.
• Translate regulatory requirements into scalable, actionable safety database configuration and operational solutions.
• Collaborate with Safety Systems Management to implement, test, and validate safety system configuration changes.
• Lead development and maintenance of countryspecific configurations, including reporting rules and reporting destinations.
• Liaise with EU/UK QPPV offices to ensure alignment of country expansion activities with global PV system and QPPV requirements (e.g., PSMF alignment, local literature monitoring, local safety contact points).

Safety Systems & Database Activities

• Lead and coordinate safety database (Argus) configuration updates and maintenance activities including expedited reporting rules and reporting destinations for clinical trial and postmarketing ICSRs.
• Lead, coordinate, and perform safety database workflow validation, User Acceptance Testing (UAT), and impact assessments for configuration changes, new study startups, and product launch preparation.
• Support safety system upgrades and enhancements from an operational perspective.

Vendor Oversight & Case Management

• Provide functional oversight and accountability for outsourced case management and safety reporting vendor activities.
• Ensure quality, consistency, compliance, and timeliness of endtoend case processing.
• Monitor metrics, KPIs, and trends to identify quality gaps and operational risks.
• Proactively manage vendor performance, including issue escalation, mitigation planning, and performance improvement actions.
• Lead and perform reconciliation activities, ensuring accuracy, completeness, and timely resolution of discrepancies in collaboration with internal teams and vendors, as applicable.

Compliance, Quality & Continuous Improvement

• Lead riskproportionate compliance monitoring activities and contribute to cross-functional quality initiatives.
• Drive investigations, root cause analyses, and contribute to corrective and preventive action (CAPA) development and effectiveness monitoring.
• Track trends and metrics, translate findings into actionable improvement plans, and monitor outcomes.
• Contribute to continuous improvement initiatives and crossfunctional projects to enhance PV operational efficiency and quality.
• Serve as a key PV Operations SME during audits and inspections, including inspection preparation and response activities.

Training & Documentation

• Create, review, and deliver training for PV operational processes and systems.
• Provide ongoing functional leadership, oversight and guidance to PV vendors and CROs.
• Author and/or review SOPs, work instructions, and guidance documents related to PV Operations and Vendor Oversight in collaboration with crossfunctional stakeholders.
• Ensure PV documentation and training materials remain current and compliant.

Required Knowledge, Skills, and Abilities

• Pharmacovigilance experience, including clinical trial and postmarketing PV.
• Demonstrated experience with global safety database configuration and maintenance (Argus).

• Strong knowledge of global pharmacovigilance regulations (including PMDA, MENA, LATAM, APAC) and ICSR reporting requirements.
• Experience supporting global product launches and country expansions.
• Experience with outsourced PV models and vendor oversight.
• Handson experience with safety systems, E2B reporting, and workflow validation/UAT.
• Strong analytical skills with the ability to identify trends and translate data into operational actions.
• Strong written and verbal communication skills.
• Ability to independently manage complex PV operational activities with minimal supervision in a matrixed, remote environment.
• Demonstrated experience managing safety reporting activities related to medical device and combination product cases, including the processing of Serious Adverse Device Effects (SADEs), device malfunctions, and compliance with applicable US Medical Device Reporting (MDR) and EU IVDR requirements.

Required Education and Licenses

• Bachelor's degree in life sciences, pharmacy, nursing, or related scientific discipline required;
• Advanced degree or healthcare professional qualification (e.g., Pharm.D., RN/BSN/MSN) preferred

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