Global Pharmacovigilance Medical Manager at Zoetis

Kalamazoo, Michigan, United States

Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Veterinary, Animal HealthIndustries

DVM (Doctor of Veterinary Medicine) or equivalent veterinary degree
Advanced degree (e.g., MSc, PhD) in pharmacology, toxicology, or related field
3+ years of experience in the Pharmaceutical Industry
Experience with FDA/USDA and international regulations on Adverse Drug Event (ADE) reporting
Experience in reviewing and analyzing pharmacovigilance data to develop trending reports

Good understanding of the ADE reporting regulations (US and EU) and of product trending standards
Collaborate with signal management team regarding validation activities for assigned products (including signal detection) to comply with FDA/USDA/EU expectations and to better understand the safety and efficacy profiles of Zoetis products post-marketing
Prepare trending reports of assigned marketed products to the pharmacovigilance stakeholders and make recommendations regarding potential safety and efficacy profile adjustments
Provide input for negotiations with regulatory agencies regarding submission of ADE reports as well as for responses to these agencies about product safety and efficacy issues
Assist in the design of pharmacovigilance policies as needed
Assist in the maintenance of a pharmacovigilance electronic system from a data capture, trend analysis and regulatory submission perspective as necessary
Function as Pharmacovigilance subject matter expert for assigned product group(s)
Provide pharmacovigilance input for advertising and promotional material upon request
Risk Mitigation in support of Global Manufacturing and Quality and Regulatory label defense activities
Complete PV Data requests and Health Hazard Assessments for assigned products upon request