Description

Kenvue is currently recruiting for:

Pharmacovigilance Specialist - Fixed term 12 months

To be based of work located at Lima, Peru; Reporting directly to the Area Safety Head for Mexico, Andean and Caribbean countries

Who We Are

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made by 22, 000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you! Join us in shaping our future-and yours.

What You Will Do?

The Pharmacovigilance Specialist 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 parties.

Key Responsibilities :

Responsible for order management activities including:

• Act as Local QPPV/ nominated responsible person for Pharmacovigilance and Cosmetovigilance in Peru.
• Receive and support the Area Safety Head in the responses to safety-related health authority queries in the territory.
• Ensure proper documented training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.
• Collaborating 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 and regional teams to implement process changes required for identification of new requirements.
• Ensure pharmacovigilance and cosmetovigilance compliance of LOC.
• Ensure current knowledge of all relevant company procedures and training.
• Supporting 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.
• Management of PV clauses to be included within local agreements.
• 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.
• 12 - 24 months of relevant experience in the Pharmaceutical industry, including product vigilance responsibility role.
• Sound knowledge of general medicine, pharmacy, and clinical practice, or another relevant scientific/medical field.

Preferred Skills and Experience:

• Sound knowledge of medical terminology
• Computer literate.
• Good verbal and written communication skills
• Ability to work independently
• Proactive
• Ability to establish and maintain open relationships within the organization and with authorities
• Fluency in English (B2 Level minimum)

What's In It For You

• Competitive Benefit Package

• Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!

• Learning & Development Opportunities

• Employee Resource Groups

• This list could vary based on location/region

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 identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.