Pharmacovigilance Medical Manager – m/w/d

🔥 13 minutes ago

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Logo of Zoetis

Zoetis

10,000+ employees

Founded 1952

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Zoetis is the world's leading animal health company, committed to nurturing the world and humankind by advancing care for animals. With over 70 years of innovation, Zoetis develops a broad portfolio and pipeline of medicines, vaccines, diagnostics, and technologies that span a continuum of care to predict, prevent, detect, and treat animal illnesses. Operating in more than 100 countries, the company supports livestock farmers, veterinarians, and pet owners around the globe. Zoetis is driven by science and their shared passion for the human-animal bond, aiming to create a more sustainable and healthier world for all.

📋 Description

• 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.

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