Global Pharmacovigilance Medical Manager
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Global Pharmacovigilance Medical Manager
Company: Zoetis
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.
About Zoetis
At Zoetis, our purpose is to nurture the world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock. We know our people drive our success. Our award-winning culture, built around our Core Beliefs, focuses on our colleagues' careers, connection and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.