Pharmacovigilance Risk Management Specialist

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 fix term contract ( parental cover).
• 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.
• 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.

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic