Pharmacovigilance Manager

Phamacovigilance Leading technologyOur client is a leading global R&D service provider for the pharmaceutical, biotech and healthcare industries. We are committed to advancing drug development through scientific excellence, operational expertise, and a strong focus on quality and compliance. As we expand our Korea operations, we are seeking a dedicated Pharmacovigilance Manager to strengthen our drug safety activities in the region.Role OverviewThe Korea Pharmacovigilance Manager will oversee all local pharmacovigilance (PV) operations to ensure compliance with Korean regulatory requirements. This role is responsible for safety reporting, PV system oversight, vendor and partner management, as well as acting as the primary liaison with local health authorities (MFDS). The ideal candidate is proactive, meticulous, and experienced in managing local PV systems within a global organisation.Key ResponsibilitiesRegulatory Compliance & Safety ReportingEnsure full compliance with Korea MFDS pharmacovigilance regulations and global PV standards.Manage timely submission of Individual Case Safety Reports (ICSRs), periodic safety reports, and risk management documentation.Maintain and update the local PV system master file (PSMF).PV Operations & OversightServe as the Local Safety Officer (LSO) / PV Responsible Person for Korea.Conduct local literature screening and safety surveillance activities.Coordinate with global safety teams to ensure alignment of processes and deliverables.Handle safety-related inquiries from authorities, partners, and healthcare professionals.Collaboration & Stakeholder ManagementPartner with regulatory, clinical, medical affairs, and commercial teams to ensure safety compliance across the product lifecycle.Support audits, inspections, CAPAs, and internal PV training.Oversee vendor activities and ensure quality performance in outsourced PV tasks.Qualifications & RequirementsBachelor’s degree or higher in Pharmacy, Life Sciences, Medicine, Nursing, or related field.Minimum 5–8 years of pharmacovigilance experience, with strong knowledge of Korea MFDS regulations.Prior experience as Local PV Responsible Person or equivalent role preferred.Strong understanding of global PV systems and good pharmacovigilance practices (GVP).Excellent communication skills in Korean and English (written & spoken).Detail-oriented, organized, and able to work independently in a fast-paced environment.