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GPV Risk Management Specialist

Req #: 180001J3_en
Location: Warsaw, MZ PL
Job Category: Patient Safety
Date Posted: 1/25/2018 12:09:46 PM
Baxter International

Description

About Baxter
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company's global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter's employees worldwide are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
Learn more about life at Baxter and watch our video!
 
 
Essential Duties and Responsibilities:
  • Write and prepare complex PV risk management documents, including EU Risk Management Plans (RMPs), ICH E2E Pharmacovigilance Planning documents and US Risk Evaluation and Mitigation Strategies (REMS) in compliance with international guidance documents
  • Manage portfolio of products/projects related to risk management planning
  • Ensure all risk management documents are prepared according to regulatory requirements and facilitate review and sign-off 
  • Organize and lead periodic review and assessment of RMPs
  • Respond to requests from regulatory authorities for changes to risk management documents 
  • Manage project timelines with respect to the preparation of risk management documents and ongoing risk minimization activities
  • Represent PV Risk Management on cross functional teams in support of Baxter products 
  • Collaborate with country organizations in developing and managing risk management documents 
  • Lead and participate in cross-functional teams and committees as assigned 

Qualifications

  • University degree in nursing/pharmacy/medical field required. Advanced degree in other non-patient care related medical/biologic fields will also be considered
  • Previous PV risk management experience, with direct experience writing and updating RMPs as primary author
  • Experience in preparing and managing RMP documents in full
  • Experience representing PV risk management function on cross-functional teams tasked with development of additional risk minimization measures and routine/additional PV activities
  • Experience leading activities related to the implementation and ongoing oversight of RMP commitments
  • Experience participating in or leading efforts related to effectiveness check studies or other methods of effectiveness evaluations. Specific experience with EU effectiveness checks is highly preferred
  • Excellent analytical and problem solving skills
  • Excellent oral and written communication and interpersonal skills
  • Proficiency working in Windows-based work processing and medical/scientific/regulatory databases/resources
 
 
A Career That Matters
Baxter's employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day. 
 
 
We offer:
  • The role with a significant global exposure with high level of responsibility and opportunity to collaborate with cross-region teams
  • Space to develop the career and fulfill ambitions
  • Opportunity to gain experience in a company with an established market position – Baxter was founded in 1930s in American Deerfield and in Poland we have been operating for over 20 years
  • Would you like to learn more about our business? Visit our profile on Linkedin.
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Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, colour, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.

 

 

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