Role Summary
Lead PV quality review activities and oversee the Quality Review Group (QRG) to ensure compliance with regulatory requirements and SOPs. Manage a team and drive high-quality adverse event case processing across the product lifecycle.
Key Responsibilities
- Oversee PV quality review, including assessment, follow-up, and tracking of adverse events
- Lead and manage QRG and Pharmacovigilance Associates to ensure quality and productivity targets are met
- Monitor team KPIs, quality metrics, and compliance with established standards
- Act as main contact for assigned projects and ensure timely deliverables
- Provide guidance on technical issues, policies, and prioritization
- Track and report performance and compliance metrics
- Identify gaps and drive continuous quality improvement initiatives
Requirements
- Bachelor's degree in Life Sciences, Pharmacy, or related field
- Minimum 5 years experience in Pharmacovigilance, including Quality Review (QR) leadership (Manager/Team Lead)
- Strong knowledge of PV regulations, ICSR processing, and quality review standards
- Proficient in MedDRA coding and PV systems (e.g., Argus preferred)
- Fluent in English with excellent verbal and written communication skills
- Strong leadership and people management skills, including coaching and performance management
- Excellent organizational, prioritization, and problem-solving abilities
- Effective project and time management skills; able to work independently and proactively
- Strong interpersonal skills with the ability to collaborate in a team-oriented environment
- Comfortable working in a fast-paced pharmaceutical environment
