Zoetis is currently looking for a Global Pharmacovigilance Medical Manager to join our team. In this role you’ll contribute to a Global Team with collective responsibility for regulatory activities associated with global pharmacovigilance including: electronic pharmacovigilance system, adverse drug experience (ADE) reports, trending reports, ADE submissions to CVM, pharmacovigilance SOPs, and Signal Management responsibilities.
Responsibilities:
- 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 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.
Basic Qualifications:
- 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
Preferred Qualifications:
- Strong interpersonal skills, ability to work under pressure and in a highly matrix environment
- Experience with database software and pharmacovigilance systems is desirable
- Ability to lead/mentor others
Full timeRegularColleague
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