Specialist, PV

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 (eg, 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 Masters 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 (eg, 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