Global Pharmacovigilance Medical Manager

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 :

Preferred Qualifications :

Full time Regular Colleague

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