This is where your work makes a difference.
At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job—you will find purpose and pride.
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:
Serve as primary author for PV-RMPs, utilizing various regional/local/company templates and ensuring compliance 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.
Qualifications:
Knowledge of worldwide PV-RMP regulations: prior experience with European Union (EU) regulations is required. Prior experience with other regional/local regulations is desired.
Prior experience with the implementation of additional risk minimization measures is desired.
Excellent analytical and critical thinking skills.
Excellent oral, written, and interpersonal skills, including ability and comfort in leading 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.
Experience in responding to queries/requests from regulatory authorities.
Education/Experience:
Nursing/biologic/medical/clinical field or other scientific degree required; prior direct clinical practice experience is desired.
Minimum two years’ prior pharmaceutical industry experience in Pharmacovigilance or Medical/Clinical functions.
Minimum two to three years’ general experience authoring PV-RMPs is required. Prior experience authoring EU RMPs is required; experience with generic PV-RMP submissions within the EU is desired. Prior experience authoring PV-RMPs in non-EU regions is desired.
We offer:
Fixed-term contract for 18 months (maternity cover).
Competitive salary, annual bonuses, recognition award program.
Possibilities for development on a personal and professional level in one of the leading global MedTech companies.
Package of benefits including Private medical care (Lux Med), Life Insurance, Multisport card.
Bax4U - cafeteria/lunch cards (300 PLN).
PPE program with very attractive conditions available for each employee after 3 months.
Educational support: 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.
Bax Flex - hybrid model (3 days from the office).
Phenomenal Warsaw office location - Powiśle!
Equal Employment Opportunity
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.
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.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice .