Pharmacovigilance Scientist, Global Patient Safety Japan_ Biopharma
The businesses of Merck KGaA, Darmstadt, Germany · JP
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About the Role
Merck Biopharma Japan is seeking an experienced Pharmacovigilance Scientist to join Global Patient Safety (GPS) Japan. This role requires strong scientific leadership in assessing, interpreting, and managing safety data for investigational and marketed products in Japan, driving product safety strategies and supporting key regulatory milestones.
Responsibilities
- Lead safety evaluation and regulatory response activities for development programs and new drug applications.
- Prepare safety components of submission dossiers.
- Support PMDA interactions.
- Respond to regulatory inquiries.
- Prepare periodic safety reports, risk management plans (RMPs), and re-examination submissions.
- Provide expert medical and scientific judgment on emerging safety issues, benefit-risk assessments, signal detection and management activities, and Japan-specific safety strategies.
- Contribute to clinical development, regulatory filings, safety governance meetings, and inspection readiness activities.
- Independently analyze complex safety information.
- Communicate recommendations to senior stakeholders.
- Influence safety-related decision-making in a fast-paced global environment.
Requirements
- 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.
Skills
- Scientific leadership
- Safety data assessment
- Safety data interpretation
- Safety data management
- Product safety strategies
- Regulatory milestones support
- Benefit-risk assessment
- Signal detection
- Signal management
- Risk management planning
- Communication
- Analysis of complex safety information
- Stakeholder communication
- Decision-making influence
Location
- Japan
Work Type
- Full-time
Experience Level
- Experienced
Education Level
- MD
- Pharmacist
- PhD
- Advanced life science degree
About the Company
- Merck's solutions in healthcare, life science, and electronics enrich people's lives.
- Merck is passionate about building a world where people, customers, patients, and the planet coexist.
- Merck fosters a diverse and inclusive culture that drives excellence and innovation.
- Merck is committed to creating access and opportunities for everyone to grow and develop at their own pace.
- Merck aims to build an inclusive and belonging culture that impacts millions and enables everyone to support human progress.