Pharmacovigilance Audit Manager

Overview

Lead the planning, conduct and reporting of risk-based pharmacovigilance (PV) and GxP audits to ensure compliance with regulatory requirements and internal procedures, and supervise and mentor junior auditors.

What you'll do

• Independently lead the planning, conduct and reporting of BRQC routine and non-routine audits, assessments and inspections of pharmacovigilance and other GxP activities, data, facilities and processes.
• Lead non-routine audits such as Due Diligence, for-cause, cross-functional and complex or sensitive system/service provider audits, and manage complex or business-critical audits in a supporting or leading role.
• Support other auditors in planning, conducting and reporting audits, and ensure standard procedures, diagnostic tools and audit plans are understood and applied.
• Support the CAPA process following audits as needed.
• Encourage and support others to manage and document the risk-based approach in audit planning and conduct.
• May participate in regulatory inspections in a leadership role (e.g. host, backroom lead).
• Identify training needs, support development and provide training, and independently advise and coach auditors.
• Review and approve curriculum as applicable, and complete training requirements in a timely manner to remain inspection ready.
• Supervise junior auditors and contractors, and deputize for the Audit Manager/Team Lead as required.
• Lead initiatives and actively participate in key projects across the organization, interacting with stakeholders to drive projects to completion.
• Actively share business area and regulatory knowledge, act as a primary contact for internal and/or external stakeholders, and conduct peer review of audit reports as required.
• Independently advise Business Partners on quality and compliance processes and procedures, and interpret and apply regulations and policies to unique or complex issues.
• Conduct and report PV/CV risk-based audits in accordance with the BRQC Annual Audit Schedule and applicable procedures (approx. 70% of time).
• Train, support and mentor PV auditors, providing meaningful feedback on performance in close collaboration with their direct manager (approx. 15% of time).
• Support training development, deployment and maintenance of the BRQC PV training curriculum, support PV inspections when required, and develop and maintain audit tools and templates for BRQC Audit Operations (approx. 15% of time).

What you'll need

• 15 years of experience in Pharmacovigilance.
• 3-5 years of experience in Pharmacovigilance Auditing.
• Bachelor's degree or equivalent in a relevant field, such as Pharmacy, Sciences, Medical or Bio related.
• Proven track record of driving business results through end-to-end collaborative deliverables.
• Strong leadership and stakeholder management.
• Expertise in PV/GxP in complex global environments.
• Strong analytical and problem-solving skills and introduction of AI capabilities.
• Ability to work collaboratively in a matrixed organization across different backgrounds.

Details

• Location: Asia Pacific, India, Karnataka, Bangalore.
• Work location: Fully remote.
• Job type: Fully remote, job location India.
• Reports to: Associate Director BRQC PV Operations.