Pharmacovigilance Medical Manager

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

📋 Description

• Strong comprehension of ADE reporting regulations in both the US and EU, along with product trending standards.

• Collaborate with the signal management team on validation activities for designated products, including signal detection, ensuring compliance with FDA/USDA/EU standards and enhancing the understanding of Zoetis products' safety and efficacy profiles post-marketing.

• Generate trending reports for assigned marketed products aimed at pharmacovigilance stakeholders, providing recommendations for potential adjustments to safety and efficacy profiles.

• Contribute to negotiations with regulatory bodies concerning the submission of ADE reports and responses related to product safety and efficacy matters.

• Support the development of pharmacovigilance policies as needed.

• Aid in maintaining a pharmacovigilance electronic system, focusing on data capture, trend analysis, and regulatory submission as required.

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

• Offer pharmacovigilance insights for advertising and promotional materials as requested.

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

• Fulfill pharmacovigilance data requests and conduct Health Hazard Assessments for assigned products upon request.

⛳️ Requirements

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

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

• A graduate degree or diploma in animal science, epidemiology, or related experience is advantageous.

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

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

• Excellent interpersonal skills, with the ability to thrive under pressure and in a complex matrix environment, are essential.

• Experience with database software and pharmacovigilance systems is preferred.

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

🏝️ Benefits

• Attractive remuneration & comprehensive social benefits: A competitive salary along with additional benefits for your security and future.

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

• Time to relax: With 30 days of holiday each year, you'll have ample opportunity to unwind and recharge.

• Career & further development opportunities: Access to tailored training, workshops, and personalized career planning for your growth.

• Together for a good cause: One paid volunteer day each year allows you to engage in social initiatives.

• Mobility that suits you: Benefit from excellent public transport connections and our mobility offerings, including a company ticket and job bike.

• Discounts & health offers: Access numerous employee discounts and a Wellhub membership for fitness and wellness.

• Focus on mental health: Confidential and free counseling services for you and your loved ones provided by the Fürstenberg Institute.

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