PV / Safety Leader

Tokyo 23 Wards Permanent Foreign Multinational
  • Lead Safety Management in Global Clinical Trials
  • Opportunity to Contribute to Clinical and Post-Marketing Studies

About Our Client

  • European pharmaceutical company with development pipeline across crucial therapeutic areas, including immunology, oncology, cardiovascular and internal medicine

Job Description

  • To develop and maintain the Risk Management Plan of the products in Japan based on the PV activities' results and other information
  • When the safety issue arises, lead to define the appropriate safety measurement through the communication with the related internal parties including JPV team and Global patient safety with external parties (including co-proportioned company, PMDA and MHLW etc.)
  • Managing quality Pharmacovigilance deliverables such as RMP(Revision), EPPV report, PMS report, J-PSUR and Re-examination package etc. of the assigned products/projects throughout the product's lifecycle
  • Work on management of PMS study, EPPV and communication of Safety Assurance Measure as PV associate member
  • Handling authorization applications and queries from regulatory authorities in and outside Japan
  • Manage overseas affiliates and license partners

The Successful Applicant

  • Monitor the benefit risk profile of assigned portfolio in an ongoing fashion by organizing PVPT and providing evaluation to Safety review Meeting (SRM) and by chairing the local Safety Management Team (SMT).

  • Ensure effective and timely delivery of safety-related documents, such as PHV part of NDA dossier, replies to Health Authority (HA) inquiries, RMP, Proper Use Guide, EPPV report, JPSUR and emergency letter.

  • Drive strategic preparation for the NDA filing/approval/launch of products in charge by fostering team spirits among PVPT and local SMT

  • Communicate in a timely, transparent and proactive manner with GPV functions about local RMP/Risk Monitoring and Risk Minimization

  • Activities including update of Global Tracking Too

What's on Offer

  • Opportunity to work on global studies
  • Contribute to PMS and clinical studies
Ed Marsden
Quote job ref
Phone number
+813 6832 8981

Job summary

What is your area of specialisation?
Healthcare / Pharmaceutical
Tokyo 23 Wards
Job Type
Consultant name
Ed Marsden
Consultant phone
+813 6832 8981
Job Reference
Company Type
Foreign Multinational