Senior Manager PVQA

This role serves as the local PV Quality lead, partnering closely with regional and global teams to ensure robust oversight of pharmacovigilance systems and regulatory compliance.

• Act as the quality partner for local Clinical Safety & PV activities, embedding Quality by Design principles across PV processes and projects.

• Review and approve critical PV quality and regulatory documentation (e.g., PSMF-related sections), ensuring alignment with global standards and local reporting requirements.

• Monitor regulatory developments, audit findings, KPIs, and quality events to identify risks and drive mitigation actions through formal governance forums.

• Lead and oversee PV-related quality investigations, including root cause analysis and CAPA execution, with timely escalation of critical issues.

• Serve as the primary QA contact for health authority inspections and partner audits; lead inspection readiness and post-inspection follow-up.

• Promote a strong quality culture through training, knowledge sharing, and continuous improvement initiatives.

• Collaborate cross-functionally with Regulatory Affairs, Medical, Legal, and global QA teams to address compliance gaps and strengthen PV quality systems.