Pharmacovigilance Senior Specialist

vor 7 Monaten

Munich, Deutschland BAXTER Vollzeit

**This is where you save and sustain lives**

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

**Your role at Baxter**

As **Pharmacovigilance Senior Specialist (M/F/d)** for Germany and Austria you will maintain an efficient local Pharmacovigilance (PV) system, meeting the European and National regulations and in compliance with the Pharmacovigilance procedures of our Kidney Care Segment. You will be the key contact point for local regulatory authorities for human medicinal products in Germany (BfArM) and Austria (BASG/AGES) regarding any pharmacovigilance issues. In this role you work close with German and Austrian General Managers and other relevant interfaces such as Regulatory Affairs, Quality Assurance, Medical Affairs, Business Units and Competent authorities.

This role is based in Unterschleißheim, near Munich (hybrid option).

**What you'll be doing**
- Collect, document, follow-up all local AEs and other pharmacovigilance information from all sources according to SOPs and national legislations; and transmit all reports to Global Patient Safety (GPS) in a timely manner
- Perform surveillance activities for any new potential safety information
- Ensure local readiness for PV inspections and audits; actively participate in the inspection/audit preparation, interview sessions and provide document requests
- Collaborate with agreement owners, country Quality and with the PV agreements team to ensure that any relevant Agreement with Third Party include appropriate PV clause or full SDEA
- Be aware of required local risk minimization activities and participate in local risk minimization activities
- Provide appropriate training on PV to employees, partners and vendors
- Monitor local compliance and ensure all efforts are made to achieve high compliance rates
- Support local/regional/global projects and take the lead when appropriate

**What you'll bring**
- Degree in Medicine, Pharmacy or in Life Science
- Minimum of 5 years professional experience in Pharmacovigilance is required in this field of activity
- Excellent analytical & problem solving skills
- Excellent oral & written communication & interpersonal skills
- Fluent German and English language skills

Join us as we revolutionize the treatment landscape and help improve patient lives worldwide.

Baxter plans to spin off our ~$5B Kidney Care segment into an independent, publicly traded company. The new standalone entity will leverage our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. With its own investment priorities and enhanced management focus, the company will be better positioned to pursue growth opportunities and invest in innovation. We will build on our leadership in the kidney care space, fueled by our steadfast focus on innovation, our passion for patients and their families and our expertise in operational excellence.

This is where you can make an impact.

**Have we sparked your interest?**

IND-DACH

**Reasonable Accommodations**

**Recruitment Fraud Notice**

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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