Pharmacovigilance Physician I / II - Fluent in Japanese - 1 year fixed term contract
Remote · Belgrade, Central Serbia, Serbia or RS
Job Summary
Pharmacovigilance Physician I/II contract role requiring medical qualification and advanced English and Japanese. Responsibilities include reviewing and approving post-marketing ICSRs/SAEs from clinical trials, providing input on regulatory deliverables such as PSURs/DSURs, literature screening, and risk management. The PV Physician may act as or support a Qualified Person for Pharmacovigilance, participate in signal detection activities, and collaborate cross-functionally to support regulatory requests. Required skills include strong pharmacovigilance expertise, ability to evaluate various safety reports, and effective communication across international teams.
Required Qualifications
- Medical degree with licensed physician status
- Pharmacovigilance experience
- Ability to review and assess ICSRs/SAEs in clinical trials
- Experience with PBRERs and DSURs
- Expertise in signal detection and risk management
- Excellent interpersonal and presentation skills
- Advanced English (spoken and written)
- Advanced Japanese (spoken and written)
- Proficiency in MS Office and cross-cultural collaboration
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