Role Summary:
The Senior Manager, PV Quality & Compliance provides leadership and oversight for the pharmacovigilance quality system to ensure inspection readiness, regulatory compliance, and effective execution of PV quality processes across internal functions and outsourced partners. This role is responsible for driving PV Agreements quality event and CAPA management, governance of PV-controlled documents and training, oversight of compliance, and support for the PSMF to sustain a robust global PV compliance framework.

Key Responsibilities:
Audit & Inspection Readiness (15%)

• Lead PV readiness activities for audits and inspections including PV SME identification, periodic gap assessments, readiness planning, and preparation of PV SMEs.
• Coordinate the development and maintenance of inspection readiness materials such as PV storyboards prepared by PV SMEs).
• Communicate end of day audit/inspection summary and request status to internal PV stakeholders.

PV Quality Management System & PSMF (20%)

• Provide oversight to ensure the effective functioning of the PV QMS in alignment with global regulatory expectations.
• Communicate compliance risks to relevant functional areas and senior management.

• Advise PV SMEs on QMS documentation standards and manage the lifecycle of PV policies, SOPs, and working instructions, including timely authoring, review, approval, and periodic maintenance.
• Support PV SMEs as needed in the coordination of PV procedure reviews and in the assignment of PV SMEs.
• Alert PV SMEs of potential impact of business process changes to controlled documents.
• Manage PV quality events and investigations, ensuring appropriate SMEs perform thorough event analysis, root cause investigation, and complete documentation of corrective and preventive actions (CAPA).
• Oversee CAPA follow-up to closure for PV findings, including those arising from audits/inspections of vendors and business partners performing PV activities on behalf of the company.
• Manage PV document repositories to ensure continuous availability, integrity, and compliance with records retention requirements (e.g. governance minutes, safety topic reviews/assessment reports, training content).
• Collaborate with the PSMF Coordinator to support the development and maintenance of the PSMF in accordance with regulatory requirements and written procedures, and act as a back-up PSMF Coordinator.

Vendor / Business Partner PV Oversight & Agreements (40%)

• Support and contribute PV expertise to audits/inspections of vendors and business partners conducting PV activities on behalf of the company.
• Manage the PV Quality Management Plan with vendors (as applicable), including authoring/review/approval and ongoing maintenance.
• Create, maintain, and distribute partner PV agreements and track stakeholder compliance with agreement requirements.
• Determine adequacy of vendor deviations and CAPA through governance meetings and discussion.

Training Governance, Compliance & Effectiveness (15%)

• Coordinate and support PV Subject Matter Experts in the development, implementation, and maintenance of PV training matrices, schedules, and curricula.
• Monitor, and escalate as appropriate, the state of compliance of PV-related training assignments for PV staff, vendors, and business partner personnel.
• Periodically confirm compliance of PV personnel qualification files with QA requirements (e.g., CVs, job descriptions, and training records).

Metrics, KPIs & continuous improvement (10%)

• Support development, implementation, and maintenance of PV KPIs used to assess the effectiveness of the overall pharmacovigilance system.

• Monitor trends and escalate critical issues to PV Management as needed

• Contribute to PV strategic initiatives and continuous improvement efforts, as required.

Other duties and responsibilities as assigned

Required Qualifications

• 8+ years of direct GvP pharmaceutical/biotechnology experience with bachelor’s degree or equivalent
• Minimum of 8 years’ experience in the Pharmaceutical/Biotechnology industry with extensive leadership experience in GxP Quality including GvP.
• Experience overseeing clinical and commercial GvP vendors.
• Solid knowledge and application of FDA, EMA and ICH GvP regulations and guidelines.
• Strong written and verbal communication skills, and analytical problem solving and conflict resolution skills.
• Flexible, highly motivated, with strong organizational skills and the ability to multitask. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic environment.
• Ability to work independently and to make decisions based on experience.
• Effective interpersonal skills.

Preferred Capabilities

• Prior Individual Case Safety Report (ICSR), Aggregate Reporting and experience with PV databases such as Argus