The role manages comprehensive Pharmacovigilance (PV) activities in Japan, ensuring full compliance with global and local regulations such as GCP, GVP, GPSP, and J-PAL. It includes supporting and substituting for the Safety Contact Person as needed. Key responsibilities encompass collecting, evaluating, and finalizing safety information and reports within regulatory timelines, managing Pharmacovigilance Agreements with external vendors, and providing safety information to stakeholders.
The role involves planning and executing Risk Management Plans (RMPs), post-marketing surveillance (PMS), and risk minimization activities, including development of guidebooks for healthcare professionals and patients. It also covers managing domestic GVP/GPSP standard operating procedures (SOPs), conducting training and audits to maintain readiness, ensuring electronic record retention, and collaborating closely with regulatory authorities such as MHLW and PMDA, as well as internal teams across Regulatory Affairs, Commercial, and R&D.
Furthermore, The role collaborates with global PV teams to support activities like Pharmacovigilance System Master File (PSMF) updates and compliance with EMA regulations. Proactive management of new product integration into PV systems and undertaking special tasks as assigned are also essential components of the role.