Pharmacovigilance Physician (Japanese fluent) – 1‑year Fixed‑Term

About the role

PrimeVigilance is seeking a medically qualified physician to join its pharmacovigilance team on a one‑year fixed‑term basis. The role requires fluency in Japanese and will involve reviewing safety data from post‑marketing activities and clinical trials.

Key responsibilities

• Review and approve post‑marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports, including coding, seriousness assessment, causality, listedness/expectedness and follow‑up.
• Act as or support the Qualified Person for Pharmacovigilance in evaluating safety issues.
• Contribute to Periodic Safety Update Reports (PBRERs), Development Safety Update Reports (DSURs), literature screening strategies and risk management plans.
• Prepare responses to regulatory authority requests and participate in signal detection activities, including writing reports and advising on benefit‑risk assessments.
• Review scientific articles for safety‑related findings and assist in the preparation of benefit‑risk reports.

Required profile

• Medical degree and qualification as a physician.
• Previous experience in pharmacovigilance, including review of aggregate safety reports.
• Demonstrated expertise in signal detection and benefit‑risk evaluation.
• Strong interpersonal, planning and cross‑cultural teamwork abilities.
• Advanced spoken and written English and Japanese.
• Proficiency with MS Office applications.

Required skills

• MS Office

What we offer

• Opportunity to work with a global, mid‑size pharmacovigilance service provider.
• Access to comprehensive training and development programmes.
• Supportive environment that values employee well‑being and work‑life balance.