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Overview:
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.
Support training of new GPS Risk Management team members.
Qualification Requirements:
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.
Educational/Work History Requirements:
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 two to three years’ general experience authoring PV-RMPs. 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 understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The minimum salary for this position is €36,800.00.00 annually. Your initial pay could be at the minimum or higher based on skills and expertise, experience, and other relevant factors, all of which are subject to change. This position may also be eligible for competitive benefits, discretionary bonuses, and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
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.
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