Senior Pharmacovigilance Study Lead
Senior Pharmacovigilance Study Lead Global pharmaceutical organisation seeking an experienced Pharmacovigilance professional to support post-marketing study activities and global safety operations. This role will focus on the management and oversight of adverse event workflows, vendor coordination, safety data management, and regulatory compliance activities across post-marketing studies. The successful candidate will play a key role in ensuring inspection readiness, supporting process improvements, and maintaining high standards of pharmacovigilance operations within a fast-paced global environment.
Key Responsibilities
- Lead and support post-marketing study safety activities including protocol review, SAE reconciliation, coding review, and study configuration
- Oversee post-marketing case processing activities within the global safety database, ensuring quality and compliance with global regulations
- Support safety reporting activities, aggregate reports, annual safety updates, and regulatory submissions
- Manage pharmacovigilance vendors and provide oversight across case management, literature surveillance, reconciliation, and QC activities
- Support system configuration, UAT testing, workflow improvements, and safety database enhancements
- Act as a key PV liaison across Quality, Clinical, Compliance, and Regulatory teams
- Develop and deliver study-specific training materials and guidance for internal teams and external vendors
- Support inspection readiness activities, audits, CAPAs, and regulatory authority queries
- Mentor junior team members and support wider PV Operations activities as required
Required Experience
- 10+ years’ experience within Pharmacovigilance / Drug Safety
- Strong experience supporting post-marketing studies and ICSR activities
- Experience with safety databases, MedDRA coding, and adverse event case processing
- Experience with study configuration and UAT testing
- Strong understanding of FDA and global pharmacovigilance regulations
- Experience managing vendors and cross-functional stakeholder relationships
- Knowledge of GxP processes, quality systems, and compliance standards
- Excellent communication, organisation, and problem-solving skills
Preferred Background
- Degree within a scientific, biological, or health-related discipline
- Experience working within global pharmaceutical or biotech environments
- Strong understanding of inspection readiness and PV operational excellence
This is an excellent opportunity to join a collaborative global team supporting complex post-marketing safety activities within a highly regulated environment.