Full Job Description
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.
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.
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 and 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.
Minimum one year 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.
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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
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.