About this role
Role Overview
- 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 pharmacovigilance data requests and Health Hazard Assessments for assigned products upon request.
Requirements
- Minimum requirement of a Veterinary Medicine (DVM, VMD)
- 5 or more years of experience in Veterinary Pharmaceutical Industry including veterinary pharmacovigilance in the European Union.
- 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.
- All EU applicants must have appropriate EU work permits obtained prior to application.
Benefits
- Attractive remuneration & comprehensive social benefits: A fair, competitive salary plus additional benefits for your security and future.
- Flexible working & remote model: Enjoy the freedom of flexible working hours with a 37.5-hour week and a possibility to work from a home office.
- Time to relax: With 30 days of holiday per year, you have plenty of opportunity to switch off and recharge your batteries.
- Career & further development opportunities: Customized training, workshops and individual career planning for your personal and professional development.
- Together for a good cause: One paid volunteer day per year so you can get involved in social causes.
- Mobility that suits you: Benefit from excellent public transport connections as well as our mobility offers such as a company ticket and job bike.
- Discounts & health offers: Access to numerous employee discounts and a Wellhub membership for fitness and wellness.
- Focus on mental health: confidential and free counselling for you and your loved ones from the Fürstenberg Institute.
- Motivating team & inspiring environment: Work in a committed, dynamic team that grows and inspires together.