Safety Review Specialist
Deerfield, IL
Req ID 51344BR
Business Title
Safety Review Specialist
Business
Global Quality
Sub-Business
Global Pharmacovigilance
Country
US
State/Province
Illinois
Location of Position
Deerfield, IL
Shift_
1st
Job Description
•Perform initial safety review and triage of adverse events to determine seriousness, expectedness and priority, including the timeline for response.
•Writes narratives summarizing all relevant medical information for individual case safety reports.
•Code medical terms using standardized medical dictionaries (such as MedDRA)
•Using expertise in therapeutic area, ensure that data has been entered and coded correctly by Data Coordinators and Medical Reviewers
•Perform case investigation to gather all required medical information, including query generation, tracking, and follow up with reporters.
•Create and issue regulatory reports, including individual case safety reports. May also include physical submissions to affiliates or Regulatory Authorities of ICSRs, as appropriate
•Take initiative to recognize, priortitize & escalate potential safety/ compliance issues
•Interact with data coordinators, medical reviewers, MedDRA/E2B coordinator, Data Integrity/IT Liaison and other functional areas within the department to process adverse events efficiently & reliably.
•Collaborate with relevant counterparts in the regional & country pharmacovigilance functions to facilitate the global exchange of safety info.
•Interface w/ other Baxter groups (e.g. Quality, Regulatory, IT, Legal, business units, etc)
•May participate in literature review activities related to adverse event reporting with oversight from more senior Safety Review team members
•Working knowledge of the assigned primary therapeutic area, a backup therapeutic area, and provide other support as necessary.
•Perform case clean up & trouble-shooting with guidance.
•Additional responsibilities & projects as assigned
Job Requirements
•Medical & clinical knowledge
•Excellent analytical & problem solving skills
•Excellent oral & written communication & interpersonal skills
•Operates effectively in a team environment
•Ability to work under strict deadlines and changing priorities with some supervision
•Working knowledge of ICH guidelines and other worldwide safety regulations
•Ability to establish priorities and proceed with accomplishing objectives
•Experience with a Global Safety Database
•Exposure to relationships with regulatory authorities Education and Experience:
•Bachelor's degree in nursing or pharmacy or equivalent
•Experience in pharmaceutical industry; Safety or Regulatory department preferred
•2+ years of hospital, patient care, or equivalent experience preferred
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
