Country Safety Officer / Country Pharmacovigilance Officer

Wat we doen

Bij Kenvue realiseren we de buitengewone kracht van dagelijkse verzorging. Gebouwd op meer dan een eeuw erfgoed en geworteld in de wetenschap, zijn we het huis van iconische merken - waaronder NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® en BAND-AID® die je al kent en waar je van houdt. Wetenschap is onze passie; Zorg is ons talent.

Wie we zijn

Ons wereldwijde team bestaat uit ~ 22.000 briljante mensen met een werkcultuur waar elke stem telt en elke bijdrage wordt gewaardeerd. We zijn gepassioneerd door inzichten, innovatie en toegewijd aan het leveren van de beste producten aan onze klanten. Met expertise en empathie betekent een Kenvuer zijn dat je elke dag de kracht hebt om miljoenen mensen te beïnvloeden. We stellen mensen op de eerste plaats, geven er veel om, verdienen vertrouwen met de wetenschap en lossen op met moed - en hebben schitterende kansen voor je klaarliggen! Geef samen met ons vorm aan onze toekomst - en die van jou. Klik voor meer informatie op here.

Rol rapporteert aan:

ASPAC Regional Head, Local PV

Locatie:

Asia Pacific, Japan, Tokyo-To, Chiyoda

Werklocatie:

Volledig ter plaatse

Wat je gaat doen

This position reports into APAC Regional Head and is based at Tokyo, Japan.

POSITION SUMMARY: The Country Safety Officer is responsible for ensuring that the local operating company (LOC) Safety activities related to all products are managed in compliance with local regulations and company policies/procedures at a local, regional, and global levels and in accordance with any product vigilance agreements with third party business partners.

**Key Responsibilities**

1.Act as Local Nominated Person (including back-up nominated person)

Function as nationally nominated person for Pharmacovigilance in respective countries assuming the Pharmacovigilance and/or Cosmetovigilance and/or Medical Device Vigilance role(s), if applicable, as defined by national law.

Local Nominated Person and their designated backups must ensure 24/7 availability within the countries where they are nominated in, if required by national law.

2.Safety Management & Reporting

• Perform regulatory monitoring for impact on vigilance activities and responsibilities.

• Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders).

• Maintain oversight of proper identification of local literature articles for AE reporting as required.

• Perform reporting/ submissions of safety reports/ updates/information (e.g., SAE, SUE, SUSARs, PSUR, RMP) to local health authorities and other Kenvue departments as applicable.

• Receive and support the Area Safety lead in the responses to safety-related health authority queries in the territory.

• Supporting Area Safety Lead in notifying local health authorities of any safety issues including SSI/ESI and Signals.

• Maintain up-to-date knowledge of local requirements for pharmacovigilance, cosmetic and device vigilances including reporting requirements (for all applicable product classes in the territory) and collaborating with the global team to implement process changes required for identification of new requirements.

• Record self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective CAPAs.

• Perform other agreed tasks assigned by manager.

• Perform document management and archiving as required.

• Perform training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.

• Perform translation for ICSR and PV-related documents, as required.

• Manage / Maintain oversight of the reporting and submission of safety reports, updates, and other safety-related information (e.g. AE, SAE, SUE, SUSARs, PBRER, DSUR, PSUR, RMP) for medicines, cosmetics, and/or medical devices to local health authorities and relevant Kenvue departments, as applicable.

3.Procedural Document

Develop, update, and implement local procedures to ensure compliance with Kenvue global procedures and national requirements.

Ensure current knowledge of all relevant company procedures and training.

4.Audit & inspection readiness

Support in local health authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA (Corrective and Preventative Action) plans as applicable.

5.PV contract management

Provide PV clauses to be included within local agreements.

6.Business Continuity

Ensure implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage).

What we are looking for

**Required Qualifications**

Education:　 Health care science professional e.g.: (nurse, pharmacist, life science degree) or equivalent training and experience

Years of Related Experience:　1-2 years of relevant experience.

Knowledge, Skills, Abilities:

• Pharmaceutical industry experience including 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 the English language.

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