Pharmacovigilance Medical Manager – m/w/d

This is a fully remote position, open to applicants in Germany.

📋 Description

• Strong knowledge of ADE reporting regulations in both the US and EU, as well as product trending standards.

• Work in collaboration with the signal management team on validation activities for designated products, including signal detection, to ensure compliance with FDA/USDA/EU standards and to enhance the understanding of the safety and efficacy profiles of Zoetis products post-marketing.

• Generate trending reports for assigned marketed products for pharmacovigilance stakeholders and provide recommendations on potential adjustments to safety and efficacy profiles.

• Contribute to negotiations with regulatory bodies regarding the submission of ADE reports and responses to inquiries about product safety and efficacy issues.

• Assist in developing pharmacovigilance policies as required.

• Support the maintenance of a pharmacovigilance electronic system concerning data capture, trend analysis, and regulatory submissions as needed.

• Act as a subject matter expert in Pharmacovigilance for assigned product groups.

• Provide pharmacovigilance insights for advertising and promotional materials upon request.

• Engage in risk mitigation efforts to support Global Manufacturing, Quality, and Regulatory label defense activities.

• Fulfill pharmacovigilance data requests and conduct Health Hazard Assessments for assigned products as needed.

⛳️ Requirements

• A minimum of a Veterinary Medicine degree (DVM, VMD) is required.

• At least 5 years of experience in the Veterinary Pharmaceutical Industry, specifically in veterinary pharmacovigilance within the European Union.

• A graduate degree or diploma in animal science and/or epidemiology or relevant experience is advantageous.

• Proficiency in reviewing and analyzing pharmacovigilance data to create trending reports is crucial.

• Familiarity with FDA/USDA and international regulations regarding Adverse Drug Event (ADE) reporting is beneficial.

• Strong interpersonal skills and the ability to perform under pressure in a highly matrixed environment are essential.

• Experience with database software and pharmacovigilance systems is preferred.

• Potential to lead and mentor others.

• All EU applicants must possess the appropriate EU work permits prior to application.

🏝️ Benefits

• Competitive salary and comprehensive social benefits: A fair salary complemented by additional benefits for your security and future.

• Flexible working and remote model: Enjoy the flexibility of working hours within a 37.5-hour week, with an option to work from home.

• Ample time to relax: With 30 days of holiday each year, you have plenty of opportunities to unwind and recharge.

• Career and development opportunities: Tailored training, workshops, and individual career planning for your personal and professional growth.

• Commitment to a good cause: One paid volunteer day each year to engage in social initiatives.

• Convenient mobility options: Excellent public transport connections and mobility benefits such as a company ticket and job bike.

• Employee discounts and health offers: Access to various employee discounts and a Wellhub membership for fitness and wellness.

• Emphasis on mental health: Confidential and free counseling for you and your loved ones through the Fürstenberg Institute.

• Motivating team and inspiring environment: Work within a dedicated, dynamic team that grows and inspires one another.