Pharmacovigilance Scientist Global Patient Safety Japan Biopharma

Job description

Job Requisition – Pharmacovigilance Scientist, Global Patient Safety Japan Merck Biopharma Japan is seeking an experienced Pharmacovigilance Scientist to join Global Patient Safety (GPS) Japan. This is a highly visible role requiring strong scientific leadership in the assessment, interpretation, and management of safety data for both investigational and marketed products in Japan. The successful candidate will play a critical role in driving product safety strategies and supporting key regulatory milestones throughout the product lifecycle. The position requires the ability to lead safety evaluation and regulatory response activities for development programs and new drug applications, including preparation of safety components of submission dossiers, support for PMDA interactions, responses to regulatory inquiries, periodic safety reports, risk management plans (RMPs), and re-examination submissions. The individual will be expected to provide expert medical and scientific judgment on emerging safety issues, benefit-risk assessments, signal detection and management activities, and Japan-specific safety strategies. Working closely with global and local cross-functional teams, the Pharmacovigilance Scientist will contribute to clinical development, regulatory filings, safety governance meetings, and inspection readiness activities. The role demands the ability to independently analyze complex safety information, communicate recommendations to senior stakeholders, and influence safety-related decision-making in a fast-paced global environment. Qualifications MD, Pharmacist, PhD, or other advanced life science degree Native-level Japanese and fluent English communication skills Significant pharmacovigilance experience, preferably across both clinical development and post-marketing settings Strong knowledge of Japanese and global pharmacovigilance regulations, signal management, benefit-risk assessment, and safety reporting Demonstrated experience working within global cross-functional teams and managing complex regulatory safety activities This role is ideal for a safety professional who can provide strategic leadership in product safety and successfully guide regulatory safety activities supporting critical development and submission objectives in Japan.