Pharmacovigilance Specialist
3 semanas atrás
**Pharmacovigilance Specialist Role**
Kenvue is a global leader in the development and manufacturing of healthcare products, and we are currently seeking a highly motivated and detail-oriented Pharmacovigilance Specialist to join our team.
This role will be responsible for supporting the Local Pharmacovigilance Organization (LPV) in the daily Safety activities related to all products managed in compliance with local regulations and company policies/procedures at local, regional, and global levels.
Key Responsibilities:
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**Safety and PV System Management**
- Regulatory monitoring for impact on vigilance activities and responsibilities.
- Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders).
- Submissions of safety reports, and updates information to local health authorities and other Kenvue departments as applicable.
- Support the Area Safety Lead in the responses to safety-related health authority queries in the territory.
- Maintain up-to-date knowledge of local requirements for pharmacovigilance, cosmetic, and device vigilances including reporting requirements and collaborating with the global team to implement process changes required for the identification of new requirements.
- Record self-identified non-conformances and collaborate with the global team to investigate non-conformances while developing and implementing effective CAPAs.
- Document management and archiving as required.
- Training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.
**Procedural Document**
- Support the applicable function in ensuring current knowledge of all relevant company procedures and training.
**Audit & Inspection readiness**
- Support in local health authority inspections and audits conducted locally.
**Qualifications**
Required Qualifications
- Bachelor's degree in progress in the Healthcare area, such as Nursing, Pharmacy, Life Science, Biology, and other careers related (at least 1 year to graduation)
- Knowledge of pharmaceutical industry experience including product vigilance responsibility role is desirable.
- Sound knowledge of medical terminology
- Microsoft Office - Excel and PowerPoint - Intermediate
- Good verbal and written communication skills
- Ability to establish and maintain open relationships within the organization and with authorities.
- Intermediate / Advanced English skills
- Availability to work for 30 hours a week, in our São Paulo site.
***
**What We Offer**
- Competitive Benefit Package
- Learning & Development Opportunities
- Employee Resource Groups
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
LI-MM1 / #RD-LA
Primary Location Latin America-Brazil-São Paulo-São Paulo
Job Function Administration
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