Senior Area Safety Officer

Senior Area Safety Officer

O que fazemos

At Kenvue, percebemos o extraordinário poder do cuidado diário. Construída com base em mais de um século de herança e enraizada na ciência, somos a casa de marcas icônicas - incluindo NEUTROGENA®, AVEENO®, TYLENOL,® LISTERINE,® JOHNSON'S® e BAND-AID® que você já conhece e ama. A ciência é a nossa paixão; O cuidado é o nosso talento.

Quem somos

Nossa equipe global é de ~ 22.000 pessoas brilhantes com uma cultura no local de trabalho onde cada voz é importante e cada contribuição é apreciada. Somos apaixonados por insights, inovação e comprometidos em entregar os melhores produtos aos nossos clientes. Com experiência e empatia, ser um Kenvuer significa ter o poder de impactar milhões de pessoas todos os dias. Colocamos as pessoas em primeiro lugar, nos importamos ferozmente, ganhamos confiança com a ciência e resolvemos com coragem - e temos oportunidades brilhantes esperando por você! Junte-se a nós para moldar nosso futuro - e o seu. Para obter mais informações, clique em aqui.

Role reporta para:

Area Safety Head United Kingdom, Local PV

Localização:

Europe/Middle East/Africa, United Kingdom, England, High Wycombe

Local de trabalho:

Híbrido

O que você fará

Senior Area Safety Officer, Local PV UK, Ireland and Nordics

This position reports into Area Safety Head and is based at High Wycombe, UK

POSITION SUMMARY: The Senior Area 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. This role will act as the Local Operating Company (LOC)’s and assigned territories 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.

PRINCIPAL RESPONSIBILITIES:
 

Oversight of the PV System & Overall responsibilities

• Provide oversight of vendor resources within the UK, Ireland and Nordic cluster.
• Support the Area Safety Head in providing relevant local information for the European Economic Area/UK Pharmacovigilance System Master Files.
• Perform other agreed tasks assigned by manager.
• Record self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective Corrective and Preventative Actions (CAPAs).

Safety Management & Reporting

• Receive and support the Area Safety Head in the responses to safety-related health authority queries.
• Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders).
• Maintain oversight of proper identification of local literature articles for Adverse Event (AE) reporting as required. 
• Perform document management and archiving as required.
• Ensure proper documented training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.
• Perform regulatory monitoring for impact on vigilance activities and responsibilities.
• Collaborate with the global and local teams to notify local health authorities of any safety issues including SSI/ESI and Signals.
• Manage reporting/ submissions of safety reports/ updates/information (e.g., SAE, SUE, SUSARs, PSUR, RMP) to local health authorities and other Kenvue departments as applicable.
• 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.
• Ensure pharmacovigilance compliance of local company sponsored programs and research activities as applicable.
• Perform translation for ICSR and PV-related documents, as required

Collaboration & Support

• Provide technical and strategic input and participate in projects/ workstreams led by the Kenvue Medical Safety teams or LOC.

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.

Audit & inspection readiness

• Support 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 plans as applicable.

PV contract management

• Management of PV clauses to be included within local agreements.

Business Continuity

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

Qualifications:
The minimum knowledge, skill, related experience, and ability requirements for the position.

Education:

Health care science professional e.g.: (preferably Physician or Pharmacist)

Years of Related Experience:

At minimum 3 years’ 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.
• Proven ability to organize workflow activities. 
• Awareness of and familiarity with industry principles of product vigilance, drug development, and pharmacology.
• Knowledge of global, regional, and local procedural documents as applicable.
• Computer literate with knowledge of relevant IT safety systems.
• Good verbal and written communication skills.
• 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 English
• Professional fluency of languages within the Nordic region is advantageous.

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