Zoetis

Manager

• Contributor to a Global Team with collective responsibility for regulatory activities associated with global pharmacovigilance
• Collaborate with signal management team regarding validation activities for assigned products
• Prepare trending reports of assigned marketed products to the pharmacovigilance stakeholders
• Provide input for negotiations with regulatory agencies regarding submission of ADE reports
• Assist in the design of pharmacovigilance policies as needed
• Function as Pharmacovigilance subject matter expert for assigned product group(s)

Medical Manager

• 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
• 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

PV Medical Manager

Research Scientist

• Independently design and analyze in vivo PK/PD, PK and TK studies in multiple veterinary species, including writing study protocols and reports
• Provide PK and PK/PD modeling and simulation to help select lead candidates and optimize dose regimens
• Collaborate with bioanalytical team to assess suitability of analytical assays and forecast analytical requirements for projects
• Lead development of scientific strategy across therapeutic areas with a focus on mechanistic platforms/biomarkers to aid in translation, measurement of target engagement, and dose regimen predictions
• Work collaboratively and communicate effectively with multidisciplinary teams to design and prosecute studies in line with the strategic direction of the project
• Present research results to scientific teams, management, and regulatory agencies
• Write sections of regulatory submissions, respond to inquiries from regulatory agencies, and maintain knowledge of regulatory guidance documents.

Medical Manager

PV Medical Manager

Principal Scientist, PK/PD