Area Safety Officer-Pharmacovigilance

The 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.

PRINCIPAL RESPONSIBILITIES:

List major responsibilities and duties of the position, including delegated duties. List most complex or difficult parts of

job first and indicate percentage of time required to perform each task. Describe those quantitative aspects of the

position which reflect measures that are applicable to the position's major responsibilities or end results.

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

Function as nationally nominated person or back up for the local nominated person for

Pharmacovigilance in respective countries assuming the PV role as defined by national law if

applicable.

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

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).

Education:

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

experience

Years of Related Experience:

1-2 years experience ICSR Pharmacovigilance is needed.

Knowledge, Skills, Abilities:

Include any required computer skills, certifications, licenses, languages, etc.

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.