Senior Manager, Pharmacovigilance Operations

Brief Description:

The Senior Manager, PV Operations provides strategic and operational leadership for global Pharmacovigilance (PV) Operations. This role drives process optimization, operational governance, vendor oversight, and crossfunctional alignment to ensure compliant, efficient, and highquality safety operations. The Senior Manager leads continuous improvement efforts, oversees endtoend postmarketing safety processes (including ICSR case processing), partners closely with internal and external stakeholders, and ensures inspection readiness across the PV function.

Essential Functions/Responsibilities

• Manage PV Operations team deliverables with high quality, compliance and strong attention to detail

• Lead strategic workstreams that enhance operational quality, efficiency, and compliance.

• Drive process modernization, system enhancements, and operational harmonization across functions.

• Identify opportunities for automation, simplification, and scalability in PV processes and systems.

• Align PV Operations initiatives with organizational priorities and quality expectations.

• Lead evaluation, redesign, and standardization of endtoend PV processes.

• Develop, maintain and optimize procedural documents and workflows.

• Oversee and facilitate ICSR workflow to ensure case processing to internal and regulatory timelines, including engagement of cross-functional stakeholders for timely completion of medical review and/or collection of complete safety information

• Design, monitor, and report KPIs, dashboards, and performance metrics.

• Promote continuous improvement, efficiency, innovation, and operational consistency.

• Ensure global compliance with case processing submission, and safety reporting requirements.

• Oversee quality initiatives, CAPA development, implementation, and effectiveness monitoring.

• Partner with Quality Assurance and Compliance to ensure alignment with quality systems, SOPs and regulatory expectations.

• Oversee strategic vendor partnerships supporting global case processing and reporting, ensuring strong KPIs, SLAs, and riskbased oversight.

• Collaborate with Global Risk Management, Safety Systems, Compliance, Clinical Operations, and Regulatory Affairs to ensure operational alignment and data integrity.

• Represent PV Operations in crossfunctional projects, system enhancements, and governance forums.

• Ensure Global clinical trials and/or post-marketed case reporting process is efficient and compliant with reporting requirements detailed in Jazz procedures, safety management plans, PV agreements, local and global regulations

• Contribute to safety database upgrades and configuration changes; perform user acceptance testing

• Provide input and guidance to submissions and case processing vendor teams

• Facilitate training and develop training materials for vendor training

• Serve as SME in audits and inspections

• May be responsible for operational tasks related to maintaining the pharmacovigilance documentation required for the electronic Trial Master File including quality review, organization, maintenance, and storage following study procedures

• Support adverse event reporting or other shared PV Operations mailbox management and monitoring, including triage and archiving of all email

• Support the timely and accurate setup of global safety reporting and safety database configurations

• Collaborate with other functional groups in SAE reconciliation and SAE query resolution activities

• Oversees, tracks, and participates in reconciliation process concerning marketed products that are the subject of safety data exchange agreements.

• Perform any other tasks/duties as assigned by management.

Required Knowledge, Skills, and Abilities

• Demonstrated leadership in PV operations, including process optimization and inspection readiness.

• Deep knowledge of global PV regulations, safety reporting obligations, and postmarketing case management.

• Strong experience managing vendors and leading matrixed, crossfunctional teams.

• Proficiency with safety databases and systems (e.g., Argus, ArisG, Veeva SafetyDocs, E2B(R3)).

• Excellent communication, analytical, and stakeholdermanagement skills.

• Experience using MedDRA WHO Drug and MedDRA coding.

• Strong understanding of medical terminology and ability to summarize medical information.

• Excellent oral and written communication skills.

• Highly organized with strong attention to detail.

• Demonstrated accountability for results, problem-solving, and decision-making abilities.

• Strong time management, prioritization, and planning skills, with the ability to work under strict timelines.

• Quality-oriented mindset with attention to detail.

• Ability to adhere to established processes and adapt to new priorities, demonstrating a continuous improvement mindset.

• Ability to work collaboratively within a team in a dynamic, fast-paced environment.

• Ability to interact effectively with people of multiple disciplines and cultures both within and outside of the company on a global basis.

• Project Management experience is a plus.

• Flexibility to work outside normal hours or on-call as needed.

• Excellent communication, analytical, and stakeholdermanagement skills.

Required Education and Licenses

• Healthcare Professional, Pharm.D., BSN/RN/MSN, or related Science Degree is required.

• Pharmacovigilance experience in the pharmaceutical industry is required.

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