Zoetis
Overview
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 Employment status: Full time Regular Colleague Equal Employment Opportunity
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Zoetis also provides reasonable accommodations as an option if requested by an individual with a disability. All applicants must possess or obtain authorization to work in the US for Zoetis.
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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 Employment status: Full time Regular Colleague Equal Employment Opportunity
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Zoetis also provides reasonable accommodations as an option if requested by an individual with a disability. All applicants must possess or obtain authorization to work in the US for Zoetis.
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