PV Medical Manager- Deputy QPPV (España)

PV Medical Manager- Deputy QPPV (España)

13 ago
|
Zoetis
|
España

13 ago

Zoetis

España

This position will be located in Spain, and it is required to live in Spain and have work permit.
Job Description
Contributor 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.

Duties and Responsibilities include but not limited to:
1. Good understanding of the ADE reporting regulations (US and EU) and of product trending standards.
2. 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.
3. Prepare trending reports of assigned marketed products to the pharmacovigilance stakeholders and make recommendations regarding potential safety and efficacy profile adjustments.
4.



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.
5. Assist in the design pharmacovigilance policies as needed.
8. Assist in the maintenance of a pharmacovigilance electronic system from a data capture, trend analysis and regulatory submission perspective as necessary.
9. Function as Pharmacovigilance subject matter expert for assigned product group(s).
10. Provide pharmacovigilance input for advertising and promotional material upon request.
11. Risk Mitigation in support of General Manufacturing and Quality and Regulatory label defense activities.
12. Complete PV Data requests and Health Hazard Assessments for assigned products upon request.
13. Act as Deputy EU/UK QPPV

Minimum requirement of a Veterinary Medicine (DVM, VMD) and 5 or more years of experience in Veterinary Pharmaceutical Industry including veterinary pharmac

📌 PV Medical Manager- Deputy QPPV (España)
🏢 Zoetis
📍 España

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