Your role at Baxter
As a member of Safety Operations Literature team within Global Patient Safety (GPS). This position serves as a subject matter expert for individual case safety reporting both in general and specific to scientific literature. Individuals will perform quality review of work performed by the PV outsource vendor providing instruction and training as needed. This position collaborates with others outside of team to review, rectify and reconcile data.
What you’ll be doing
Supervise quality of abstract review, article review, and individual cases processed by PV agencies through random QC of cases or through review of aggregate data.
Provide training to outsource vendor for Literature review and case processing. This includes coordinating new hire training and certification and ongoing training and feedback for existing vendor staff.
Process literature adverse event reports as needed as a part of a cross-functional team.
Interface and collaborate with other functional partners at Baxter (e.g., Regulatory Affairs, IT, Legal, Customer Service, etc.) Collaborate with local and regional Patient Safety team members to facilitate the global exchange of safety information.
Participate in compliance supervising related activities including CAPA and Quality Control Metrics.
What you’ll bring
Bachelors or Master’s degree in Pharmacy
Minimum 2 years patient care, or equivalent experience AND minimum 1 year experience required as Safety Review Specialist or proficiency in a Global Safety Database (e.g., ARISg, Argus)
Knowledge of multiple therapeutic areas equivalent position
Experience in pharmaceutical industry- Quality, Pharmacovigilance or Regulatory department
Excellent analytical & problem-solving skills
Excellent oral and written communication
Collaborative interpersonal skills to cultivate a team environment
Ability to work independently under deadlines and changing priorities
Able to multitask and prioritize changing workload every day
In-depth knowledge of worldwide and regional safety regulations
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.
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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.
- Req # JR – 138198
- Location: Ahmedabad, Gujarat, India
- Job Category: Patient Safety