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.

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

• 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.

Benefits

• This position is also eligible for short-term incentive compensation
• This position is also eligible for long-term incentives
• In addition to compensation, Zoetis offers a comprehensive benefits package that supports the physical, emotional and financial wellbeing of our colleagues and their families including healthcare and insurance benefits beginning on day one, a 401K plan with a match and profit-sharing contribution from Zoetis, and 4 weeks of vacation.
• Visit zoetisbenefits.com to learn more.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Ph.D. or professional degree