Pharmacovigilance Risk Management Specialist

1 dzień temu

Warszawa, Mazovia, Polska Baxter Pełny etat

Transforming Healthcare through Pharmacovigilance and Risk Management

Baxter is a leading global medical technology company committed to saving and sustaining lives. We are seeking a highly skilled Pharmacovigilance Risk Management Specialist to join our team in Warsaw.

About the Role:

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

Key Responsibilities:

  • Facilitate cross-functional review and approval of PV-RMPs.
  • Respond to queries/requests from regulatory authorities regarding PV-RMPs.
  • Independently lead project timelines associated with the preparation and submission of PV-RMPs.
  • Represent GPS Risk Management on cross-functional teams.
  • Collaborate with country organizations in developing and leading PV-RMPs and associated dedication activities.
  • Assist RM manager/commitment tracking tool owner with planning and oversight of PV-RMP commitments.

Requirements:

  • 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 the ability to lead cross-functional group discussions and meetings.
  • Scientific/clinical knowledge and excellent scientific writing skills.
  • Ability to independently lead long- and short-term project timelines and deliverables.
  • Exposure to working relationships with regulatory authorities.

What We Offer:

  • Competitive salary, annual bonuses, recognition award program.
  • Company culture based on our values: collaboration, speed, courage, and simplicity.
  • Possibilities for development on a personal and professional level in one of the top-tier global MedTech companies.
  • Package of benefits including Private medical care (Lux Med), Life Insurance, and Multisport card.
  • Bax4U - cafeteria/lunch cards (300 PLN monthly).
  • PPE program with very attractive conditions available for each employee after 3 months.
  • Fully covered language courses (English or other languages according to business needs).
  • Co-financing of holidays and an additional 2 days off from work annually.
  • Employee Stock Purchase Plan.
  • Great Warsaw office location - Powiśle.

Baxter is committed to supporting the need for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in person in support of our Mission.

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