Pharmacovigilance Medical Senior Associate II/Manager I/Manager II

Anticipated role level: Senior Associate II/Manager/Manager II

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:

• 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.

Minimum requirement of a Bachelor's degree in science related field and 3 to 5 or more years of experience in Pharmaceutical Industry. 

Additional graduate degree or diploma in animal science, veterinary medicine (DVM,VMD, BVSc,BVetMed) and/or epidemiology or related experience is a plus. 

Knowledge of the FDA/USDA and international regulations on Adverse Drug Event (ADE) reporting is required as well as the ability to review and analyze pharmacovigilance data to develop trending reports. 

Strong interpersonal skills, ability to work under pressure and in a highly matrix environment are essential. 

Experience with database software and pharmacovigilance systems is desirable. May lead/mentor others.

Full timeRegularColleague

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