The Senior Manager, Global Pharmacovigilance (PV) Quality Assurance is a key member of the GVP QA team, providing global quality oversight of post-marketing pharmacovigilance systems. This includes ensuring compliance with EMA Good Pharmacovigilance Practices (GVP) Modules, FDA regulations, and other international PV requirements. The role will also support the development and execution of the GVP audit program and inspection readiness initiatives.
Key Responsibilities:
* Provide quality oversight of global pharmacovigilance (PV) systems and ensure alignment with applicable GVP regulations and guidelines.
* Support and partner with Expertise Areas (EAs) in the development and review of procedural documents related to PV and Post-Marketing Surveillance (PMS).
* Ensure compliance of non-interventional, observational, and PMS studies with regulatory expectations (GPP, GPSP).
* Participate in and lead core auditing processes, including internal audits, vendor audits, and audits of licensing partners and affiliates.
* Manage quality events by assessing root cause analyses and corrective and preventive actions (CAPAs); apply risk-based thinking to decision-making.
* Contribute to the Global Strategic Audit Program by developing risk-based audit strategies and maintaining the PV audit universe and tools.
* Support development and maintenance of the PV System Master File (PSMF), including QA Audit, CAPA, and supplier data.
* Provide quality oversight of PV- and PMS-related vendors (e.g., qualification assessments, audits, KQIs, quality agreements).
* Assist in PV and PMS inspection readiness and management.
* Generate and report GVP QA metrics and dashboards.
* Develop and deliver PV and PMS training for QA and other business units.
* Identify and propose continuous improvement initiatives across PV QA processes.
* Support cross-GxP QA activities and other assignments as directed.
Qualifications & Requirements:
* Bachelor’s degree in Life Sciences or related field required; Master’s degree preferred.
* Minimum of 5 years of relevant experience in the pharmaceutical industry, with 10+ years strongly preferred.
* Demonstrated experience in PV Quality Assurance, including conducting or supporting GVP audits.
* Solid knowledge of international PV regulations (EMA, FDA, ICH, etc.) and experience supporting health authority inspections.
* Experience working with PSMF and familiarity with medical affairs and regulatory requirements.
* Strong collaboration and communication skills with a proactive and flexible work style.
* Ability to work independently with strong analytical and strategic thinking skills.
* Comfortable managing sensitive information with diplomacy and discretion.
* GCP experience is a plus.
* Hybrid
* 6 Months
* Interview Process: 3 Rounds
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