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About the Role
The Country Safety Officer is responsible for managing local safety activities for all products, ensuring compliance with local regulations and company policies. This role ensures adherence to global standards and product vigilance agreements with third-party partners.
Responsibilities
- Act as the Local Nominated Person for Pharmacovigilance, Cosmetovigilance, and/or Medical Device Vigilance as defined by national law.
- Ensure 24/7 availability as a nominated person if required by national law.
- Perform regulatory monitoring for impact on vigilance activities.
- Conduct reconciliation with other departments, distributors, third parties, vendors, and internal stakeholders.
- Maintain oversight of local literature articles for AE reporting.
- Report and submit safety reports/updates/information to local health authorities and Kenvue departments.
- Support the Area Safety Lead in responding to health authority queries and notifying them of safety issues.
- Maintain up-to-date knowledge of local pharmacovigilance, cosmetic, and device vigilance requirements.
- Collaborate with the global team to implement process changes for new requirements.
- Record and investigate self-identified non-conformances, developing and implementing CAPAs.
- Perform other assigned tasks by the manager.
- Manage document management and archiving.
- Provide training on safety reporting responsibilities and maintain general safety reporting awareness.
- Translate ICSR and PV-related documents as required.
- Oversee the reporting and submission of safety reports for medicines, cosmetics, and medical devices.
- Develop, update, and implement local procedures for compliance with global procedures and national requirements.
- Ensure current knowledge of company procedures and training.
- Support local health authority inspections and audits.
- Collaborate with the global team to develop and implement CAPA plans.
- Provide PV clauses for inclusion in local agreements.
- Ensure implementation of local business continuity plans, including inspection readiness and AE reporting coverage.
Requirements
- Health care science professional (e.g., nurse, pharmacist, life science degree) or equivalent training and experience.
- 1-2 years of relevant experience.
- Pharmaceutical industry experience including a product vigilance responsibility role.
- Sound knowledge of general medicine, pharmacy, and clinical practice, or another relevant scientific/medical field.
- Sound knowledge of medical terminology.
- Computer literate.
- Good verbal and written communication skills.
- Ability to establish and maintain open relationships within the organization and with authorities.
- Fluency in the national language(s) and English.
Skills
- Pharmacovigilance
- Cosmetovigilance
- Medical Device Vigilance
- Regulatory Monitoring
- Safety Reporting
- CAPA Management
- Document Management
- Training
- Translation
- Business Continuity Planning
Location
- Tokyo, Japan
Work Type
- Fully Onsite
Experience Level
- 1-2 years
Education Level
- Health care science professional (e.g., nurse, pharmacist, life science degree) or equivalent training and experience
About the Company
- Kenvue is built on over a century of heritage and rooted in science, being the house of iconic brands like NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S®, and BAND-AID®.
- Our global team consists of ~22,000 brilliant people with a workplace culture where every voice matters and every contribution is appreciated.
- We are passionate about insights, innovation, and committed to delivering the best products to our customers.
- Being a Kenvuer means having the power to impact millions of people every day through expertise and empathy.
- Our values include putting people first, caring fiercely, earning trust with science, and solving with courage.