This role leads the execution of regulatory and pharmacovigilance (PV) activities across medium to high-complexity projects, ensuring timely delivery and adherence to global standards. The position drives project coordination, supports strategic planning, and acts as the designated Local Contact Person (LCP) for Pharmacovigilance in the assigned country.
Key Responsibilities
- Lead functional delivery for projects, ensuring alignment with established procedures, timelines, and performance metrics
- Act as the primary LCP for PV, including maintaining up-to-date records, training compliance, and performance tracking
- Monitor team task allocation, project hours, and budget utilization, escalating variances as needed
- Support the development of project strategies, operational plans, and core documentation in collaboration with senior team members
- Identify risks early and implement corrective or preventive actions to maintain project integrity
- Prepare and review client and vendor invoices, ensuring financial accuracy
- Contribute to business development efforts, including budget input and proposal support
- Deliver training, coaching, and mentorship to junior staff to strengthen team capability
- Maintain strong working relationships with internal departments, clients, and external partners
- Stay current with evolving regulatory requirements and manage updates to internal regulatory intelligence systems
- Support audit and inspection readiness, including preparation and representation for assigned projects
- Provide performance feedback on vendors and contribute to continuous improvement of SOPs and workflows
Qualifications and Experience
The ideal candidate will have proven experience in regulatory affairs or pharmacovigilance project management, with a solid understanding of compliance frameworks and global PV requirements. Experience serving as an LCP or in a comparable regulatory role is essential. The role requires strong organizational, communication, and leadership skills to manage cross-functional teams and ensure delivery excellence.
