About the role
Position Summary
As a Specialist, Pharmacovigilance, you will play a critical role in ensuring the safety and compliance of Nestle's VMS, Cosmetic, and OTC products You will manage adverse event case reviews, documentation, assessments, and MedWatch submissions in line with FDA regulatory guidelines. This position also supports Medical Nutrition products, collaborates with Medical Affairs, and contributes to product lifecycle improvements through scientific analysis and hypothesis generation.
You will work closely with cross-functional teams including Regulatory & Scientific Affairs, Medical Affairs, Quality, and Consumer Engagement Services, reporting directly to the Pharmacovigilance Manage
Key Responsibilities
- Review and assess adverse events daily for NHSc VMS brands in compliance with DSCPA.
- Conduct follow-up intakes with consumers and healthcare entities via phone, mail, or electronic channels, ensuring accurate documentation.
- Complete serious adverse event narratives using MedWatch Form 3500A and report to FDA within 15 days.
- Code adverse events by System Organ Classification in Salesforce for trend analysis.
- Initiate product reviews or investigations based on hypotheses or events of concern.
- Maintain up-to-date knowledge of FDA guidelines, regulatory requirements, and internal procedures.
- Stay informed on nutrients, ingredients, and structure-function claims.
- Perform other duties as assigned.
Key Relationships
- NHSc US Regulatory Operations & Compliance team
- Regulatory & Scientific Affairs
- Medical Affairs
- Quality
- Consumer Engagement Services
Experience and Education Requirements
- Bachelor’s degree in Science, Nutrition, Nursing, Pharmacy, Chemistry, or related discipline
- RN, Pharmacist, Registered Dietitian, or other healthcare provider license required
- 3–5 years of clinical experience in a healthcare discipline
- Product Safety or Pharmacovigilance experience preferred
- Familiarity with Salesforce, Veeva, and SAP is a plus
- Strong decision-making and prioritization skills
Preferred Skills
- Working knowledge of FDA regulatory requirements
- In-depth understanding of medical terminology, disease states, and treatments
- Ability to interpret research literature and apply statistical concepts
- Strong critical thinking, analytical, and organizational skills
- Ability to work independently and meet deadlines
- Excellent verbal and written communication skills
- Proficiency in basic computer applications
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