Pharmacovigilance Medical Manager (m/w/d)

We are hiring a Pharmacovigilance Medical Manager (m/f/d)

Contract type: remote contract based in Germany.

You would be a 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, and Signal Management responsibilities.

Your responsibilities:

• 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.

What we are looking for:

• 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.

What we offer:

• 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.

Our vision and values at Zoetis

At Zoetis, we aim to be the most trusted and valued animal health company by shaping the future of animal health through innovation, customer focus and dedicated employees. Our values are the compass that guides us: Integrity, passion for our customers, working together as a collective force and striving for excellence.

Does the role sound interesting for you? Would you like to join Zoetis?

Then we are looking forward to your application!

You can find more information about our company at www.zoetis.com

Any unsolicited resumes sent to Zoetis from a third party, such as an agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.

Notice: Zoetis Recruiters will contact candidates via email from an address ending in @zoetis.com and may also initially connect with candidates through LinkedIn, including LinkedIn InMail. Zoetis does not use Gmail, Outlook, Yahoo, or other web-based/generic email domains to communicate about job opportunities, interviews, or offers of employment. If you receive a recruitment-related email message claiming to be from Zoetis that does not come from @zoetis.com, please treat it as suspicious. For your security, do not reply, click links, open attachments, share personal or financial information, or send money in response to unexpected or questionable recruitment communications.

Originally posted on Himalayas