Global Regulatory Affairs and Pharmacovigilance at Baxter
A Truly Global Function
Pharmacovigilance
Regulatory Affairs
GRAPV Center of Excellence
GRAPV Development Opportunities
Qualifications
How to Apply
Global Regulatory Affairs and Pharmacovigilance at Baxter
The Global Regulatory Affairs and Pharmacovigilance (GRAPV) function at Baxter is responsible for ensuring that safe and effective biologics, medical devices and pharmaceuticals are available worldwide. A career in the GRAPV function has the potential to expose an individual to a variety of disciplines, including marketing, research and development, clinical affairs, manufacturing, advertising and post-market surveillance.
A Truly Global Function
GRAPV at Baxter reports to Baxter’s chief scientific officer and is truly a global function with career opportunities in North America, Latin America, Europe and Asia Pacific. The function is structured into teams based on specialties and areas of expertise in biologics, medical devices and pharmaceuticals.
Pharmacovigilance
Pharmacovigilance professionals are focused on the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients about the adverse effects of biological products and medications. Special attention is given to identifying new information about potential hazards associated with medicines and preventing harm to patients.
Pharmacovigilance consists of safety operations, risk management, safety data exchange agreements and medical writing.
Regulatory Affairs
Regulatory Affairs professionals are focused on developing global regulatory strategies for new and novel products, collaborating with regulatory bodies worldwide to set standards for new technologies, supporting clinical development activities, filing regulatory submissions and ensuring regulatory compliance across the product lifecycle, among other critical responsibilities.
GRAPV Center of Excellence
The Operations Center of Excellence develops the strategy and processes for managing information (data and documents) within Regulatory Affairs and also oversees the design, development and implementation of policies, procedures and training.
GRAPV Development Opportunities
GRAPV professionals at Baxter can make a meaningful difference for patients around the world while also expanding their skills in strategic planning, problem solving, scientific analysis, process/project quality standards, communication, submission and project management, risk assessment and contingency planning. GRAPV professionals have the opportunity to gain experience working with different products within Baxter's diversified portfolio, work across a variety of functional areas, advance their knowledge in specialty areas such as bioscience, medication delivery, and renal, or develop a career with broad product responsibility within a specific region.
Qualifications
Baxter looks for talented and driven regulatory affairs professionals who have:
- Regulatory, pharmacovigilance, scientific or technical expertise;
- The ability to translate the business and scientific information for Baxter’s products into an easily understandable submission or report to a regulatory agency;
- Experience with biologics, medical devices, pharmaceuticals and/or pharmacovigilance;
- Strong communication skills to facilitate discussions and negotiations with internal business partners and regulators; and
- Solid experience collaborating with internal business partners and global regulatory authorities.
