Review and approve ICSRs and SAEs for medical/causality assessment, including seriousness and listedness evaluations.
Act as or support the Qualified Person for Pharmacovigilance, providing medical input on safety issues and aggregate reports.
Participate in signal detection, prepare risk management plans, and respond to regulatory authority requests.

Qualifications:

Medical qualification as a physician with prior pharmacovigilance experience.
Expertise in signal detection and review of aggregate reports like PBRERs and DSURs.
Advanced proficiency in English and Japanese, with strong interpersonal and organizational skills.

Additional Information:

The company emphasizes diversity, equity, and inclusion in a supportive, global work environment.
Core values include quality, integrity, passion, and collaboration, with a focus on personal and professional growth.
This is a one-year fixed-term contract, offering the opportunity to contribute to patient safety worldwide.

PrimeVigilance

PrimeVigilance is a specialized pharmacovigilance service provider offering support in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance to pharmaceutical and biotechnology partners globally. It is a mid-size company that values employee training, well-being, and a healthy work-life balance, fostering a collaborative, human-centric environment with team members across continents.

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