Pharmacovigilance Risk Management Specialist (12-months contract)

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.

Summary

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

What you'll be doing?

Serve as the author for PV-RMPs, applying 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 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.

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 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.

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-proven experience in Pharmacovigilance or Medical/Clinical functions.

What we offer:

• 1-year fixed-term contract (maternity cover) with the possibility to extend to permanent.

• Competitive salary, annual bonuses, recognition award program.

• Company culture is 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.

• Day off for birthday!

• Employee Stock Purchase Plan.

• Great Warsaw office location - Powiśle!

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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