PV Medical Manager

Zoetis

2d•$114,000 - $185,000

About The Position

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: 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.

Requirements

Minimum requirement of a Veterinary Medicine (DVM, VMD) and 5 or more years of experience in Veterinary Pharmaceutical Industry including veterinary pharmacovigilance in the US and/or EU
Ability to review and analyze pharmacovigilance data to develop trending reports is essential
Strong interpersonal skills, ability to work under pressure and in a highly matrix environment is essential

Nice To Haves

Additional graduate degree or diploma in animal science and/or epidemiology or related experience is a plus
Knowledge of the FDA/USDA and international regulations on Adverse Drug Event (ADE) reporting is a benefit
Experience with database software and pharmacovigilance systems is desirable
May lead/mentor others

Responsibilities

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
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