Safety Data Coordinator

Job Category: Administrative/Clerical Company: Baxter Healthcare Reference Code: 31378BR Safety Data Coordinator Baxter International Inc., assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives. Our 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 with special attention on identifying new information about potential hazards associated with the medicines as well preventing harm to patients. Pharmacovigilance consists of safety operations, risk management, safety data exchange agreements, and medical writing. As a Safety Data Coordinator, you will be responsible for: Register cases into the Global Safety database and perform systematic review of the Global Safety database to ensure that duplicate case entry does not occur (i.e., "duplicate check"). Create & label adverse event case files Perform data entry of adverse events Verify data against source documents Run standard and ad hoc queries in the Global Safety Database Develop & maintain expert knowledge of the Global Safety database Collaborate with other GPV staff concerning adverse events & other safety-related issues Support case report distribution & submission Initial point of contact for calls coming through the Global Pharmacovigilance Hotline (Deerfield only) Provide input into & assistance with improving the efficiency & function of the data management functions Design & enhance standard department document formats Interface with other Baxter functions in regards to data clarification and reconciliation Develop focus and expertise in the assigned primary therapeutic area, a backup therapeutic area, and provide other support as necessary. Take initiative to recognize, prioritize & escalate potential safety/ compliance issues Train staff in use of the safety database Participate on project teams & committees, as assigned   QUALIFICATIONS: Excellence in document processing & ability to consistently produce high quality work Strong organizational skills & attention to detail Ability to multitask and prioritize Excellent written & oral communication skills Capacity to analyze & resolve problems with analytical & problem solving skills Ability to work under strict deadlines & changing priorities with minimal supervision Operates effectively in a team environment Technical system skills (e.g. word processing, spreadsheet and Safety Databases) Strong customer service orientation Knowledge of ICH guidelines & other worldwide reporting regulations Working knowledge of Global Safety Database and Reference Manager Application Knowledge of medical terminology High school degree or equivalent required Higher degree in natural sciences or health profession is preferred Related experience in medical documentation, Pharmacovigilance, Regulatory affairs, clinical research, quality assurance, medical support or biochemical laboratory Previous experience in medical/clinical data processing   As a global leader dedicated to building the best team in health care, Baxter offers competitive compensation and full benefits. To view other opportunities at Baxter, please visit our Careers@Baxter site. EOE M/F/D/V.