[Hiring] Medical Manager @Zoetis

Role 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
• Signal Management responsibilities

Duties and Responsibilities include but are 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 of 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.

Qualifications

• 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.
• Additional graduate degree or diploma in animal science and/or epidemiology or related experience is a plus.
• Ability to review and analyze pharmacovigilance data to develop trending reports is essential.
• Knowledge of the FDA/USDA and international regulations on Adverse Drug Event (ADE) reporting is a benefit.
• Strong interpersonal skills, ability to work under pressure and in a highly matrix environment is essential.
• Experience with database software and pharmacovigilance systems is desirable. May lead/mentor others.

Requirements

• The US base salary range for this full-time position is $114,000 - $185,000.
• This position is also eligible for short-term incentive compensation.
• This position is also eligible for long-term incentives.

Benefits

• 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.
• 401K plan with a match and profit-sharing contribution from Zoetis.
• 4 weeks of vacation.