Country Safety Head, Japan

Country Safety Head, Japan

Wat we doen

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Wie we zijn

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Rol rapporteert aan:

ASPAC Regional Head, Local PV

Locatie:

Asia Pacific, Japan, Tokyo-To, Chiyoda

Werklocatie:

Hybride

Wat je gaat doen

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

POSITION SUMMARY: The Country Safety Head 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.

This role will act as the Local Operating Company (LOC)’s and assigned territories (as applicable) main point of contact for pharmacovigilance matters with the local health authority.

They will ensure that appropriate product vigilance and risk management systems are set in place to assure appropriate oversight of products within its responsibility.

**Key Responsibilities**

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

Function as nationally nominated person Anseki (安全管理責任者) 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.

Oversight of the PV System & Overall responsibilities

• Provide line management and/or oversight of vendor resources in the countries in scope.
• Function as a delegate for the Regional Safety Head, when required.
• Managing and coaching of the direct reports as applicable.
• Ensure that day-to-day PV functions are performed satisfactorily, and that optimal regulatory compliance is maintained at the LOC level.
• Escalate compliance issues in a timely manner to Regional Safety Head to ensure appropriate mitigation is implemented.
• Advise the local business on the PV impact of local organized data collection programs.
• Recording self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective CAPAs.
• Identify periods of high PV workload and manage PV resource appropriately to address them.
• Providing relevant local information for the European Economic Area/UK Pharmacovigilance System Master Files while collaborating with the global team to meet requirements for local PSMFs if applicable.
• Ensure compliance with pharmacovigilance, cosmetovigilance, and/or medical device vigilance requirements applicable to the territory, in accordance with national legislation.

Safety Management & Reporting

• Maintaining oversight 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.
• Maintain oversight on day-to-day AE inbound and outbound reporting as applicable.
• Supporting in the responses to safety-related health authority queries in the territory if applicable.
• Ensure awareness of changes in regulations which may have an impact on vigilance activities and responsibilities. Evaluate the impact on local processes and inform the appropriate global and regional groups of any changes to local laws and regulations regarding safety.
• Accountable for the provision of information to the global teams for local activities compliance with individual cases and periodic safety reporting, implementing of risk management plans, and key performance indicators related to overseeing local implementation of any other specific risk management activities.
• Ensure proper documented 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.

Collaboration & Support

Provide technical and strategic input and participate in projects/ workstreams led by the KMS teams or LOC.

Procedural Document

Ensure implementation of the local procedures where applicable and assessing the impact of changes for the global procedure to local procedures

Audit & inspection readiness

Lead 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.

PV contract management

Maintain an oversight on the local PVAs and ensure local implementation, including LSU training and adherence to PVAs.

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 (preferably Physician or Pharmacist)

Years of Related Experience:　6-8 years of relevant experience.

Knowledge, Skills, Abilities:

• Pharmaceutical industry experience including product vigilance responsibility role.
• Experience as line manager and vendor resource oversight.
• Ability to organize workflow activities and manage multiple critical issues.
• Awareness of and familiarity with industry principles of product vigilance, drug development, and pharmacology.
• Expert knowledge of global, regional, and local procedural documents as applicable.
• Computer literate with knowledge of relevant IT safety systems.
• Excellent verbal and written communication skills.
• Ability to negotiate and communicate with internal and external customers.
• Ability to establish and maintain open relationships within the organization and with authorities.
• Demonstrable knowledge of all local requirements and of global aspects of product safety.
• Fluency in the Japanese and the English language.

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