Pharmacovigilance Risk Management Specialist

Pharmacovigilance Risk Management Specialist

Baxter International

Warsaw, Poland

Summary

This position is part of the Risk Management function within the GPS organization, responsible for development and management of Pharmacovigilance Risk Management Plans (PV-RMPs) to support Baxter’s drug and biologic products.

Essential Duties and Responsibilities

  • Serve as primary author for PV-RMPs, utilizing various regional/local/company templates and ensuring all PV-RMPs are prepared according to regional/local regulatory requirements.
  • Facilitate cross-functional review and approval of PV-RMPs.
  • Respond to queries/requests from regulatory authorities regarding PV-RMPs.
  • Independently manage project timelines associated with preparation and submission of PV-RMPs.
  • Represent GPS Risk Management on cross-functional teams.
  • Collaborate with country organizations in developing and managing PV-RMPs and associated commitment activities.
  • Assist RM manager/commitment tracking tool owner with planning and oversight of PV-RMP commitments.

Qualifications

  • Knowledge of worldwide PV-RMP regulations: prior experience with European Union (EU) regulations is required. Experience with other regional/local regulations is desired.
  • Excellent analytical and critical thinking skills.
  • Excellent oral, written, and interpersonal communication skills, including ability to lead cross-functional group discussions and meetings.
  • Scientific/clinical knowledge and excellent scientific writing skills.
  • Ability to independently manage long- and short-term project timelines and deliverables.
  • Exposure to working relationship with regulatory authorities.

Education/Experience

  • Bachelor’s degree in nursing/biologic/medical/clinical field; advanced degree and prior clinical practice experience is desired.
  • Minimum two years’ prior pharmaceutical industry experience in Pharmacovigilance or Medical/Clinical functions.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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