Global Drug Safety Physician,

vor 2 Wochen

Wien, Österreich 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 a Drug Safety Physician, you’ll work in patient safety on a global scale by providing medical expertise across a wide range of activities for pharmaceutical products and ensure that appropriate medical interpretation, review, and guidance are consistently applied.
- Perform benefit-risk safety analysis, including safety surveillance activities for potential safety signals, aggregate safety data review, risk management plans and Risk Evaluation and Mitigation Strategy (REMS), Regulatory Authority assessment reports and queries, and periodic documents, such as Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Periodic Adverse Drug Experience Reports (PADERs).
- Provide medical review for a limited number of individual case safety reports, including coding, seriousness, expectedness, Baxter causality assessment for an assigned therapeutic area, and QC and training of outsource vendor.
- Ensure that appropriate medical interpretation and consistency are applied to periodic documents, product labels, and adverse event case assessment.
- Work with clinical counterparts as needed, including review of clinical trial protocols, safety management plans, development plans, and serious adverse event handling.
- Be the pharmacovigilance expert for assigned medicinal products and maintain current knowledge of full product portfolio and safety profiles for products.
- Communicate and interact effectively within and across Global Business Units and within Functional Team Management, as appropriate.
- Provide pharmacovigilance support for internal and external customers.

**What You’ll Be Doing**:

- Perform benefit-risk safety analysis, including safety surveillance activities for potential safety signals, aggregate safety data review, risk management plans and REMS, Regulatory Authority assessment reports and queries, and periodic documents, such as PSURs, PBRERs, and PADERs. Ensure that appropriate medical interpretation and consistency are applied to periodic documents, product labels, and adverse event case assessment.
- Perform aggregate safety data review, safety surveillance activities to review for potential safety signals and provide guidance on the regulatory status for expedited reporting and/or signal detection.
- Support internal and external customers related to the evaluation of issues and adverse events related to licensed products safety and efficacy. Share medical/clinical expertise with counterparts in other functional areas such as quality assurance, regulatory affairs, marketing, manufacturing, and legal globally.
- Provide medical and scientific expertise on pharmacovigilance matters affecting the preparation and submission of timely and accurate information to the regulatory authorities. Review and provide assurance of medical/pharmacovigilance content and clinical relevance of regulatory safety documents including Investigators' Brochures, PSURs, PBRERs, and ad hoc regulatory reports as assigned. This includes input to PSURs, PBRERs, and Periodic Adverse Drug Experience Reports (PADERs) with focus on providing overview for the medical analysis and safety sections.
- Work with the global labeling team to accurately portray the safety profile of assigned drugs.
- Serve as a medical liaison between Global Patient Safety and other Global Business Unit medical team members.
- Maintain knowledge of global regulatory authority regulations (especially FDA and EMA).
- Contribute to the training, leadership and continuing education for all departmental staff.
- Due diligence for portfolio acquisitions.

**Your Team**:
Reporting to the Lead, Drug Safety Physician, you will collaborate with team members including other Drug Safety Physicians, Drug Safety Scientists, as well as other team members from Global Patient Safety, the Worldwide Medical organization, Regulatory Affairs, etc.

**Your Location**:The role is located at our facility in Vienna, Austria.

**What You’ll Bring**:

- M.D. degree and board certification/eligibility in a specialty appropriate to the products of the division are required.
- Excellent teamwork and interpersonal skills are required.
- 5 years of experience post-residency,

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