Safety Associate

At Baxalta, we share a common set of values and behaviors that represent what we stand for and how we work together to achieve our promise to patients.

This position is a member of the US Affiliate Organization within the Safety Operations team of Global Drug Safety and serves as a case owner for adverse events to ensure timely and accurate review, processing, and reporting as well as front-line staff for the interaction with consumers

• Basic understanding of domestic and international drug safety regulations.
• May perform initial triage of source documents for duplicate check within the Global Safety Database, case priority, Baxalta Awareness Date, and closure/submission timeline.
• Perform initial safety review of adverse events to determine seriousness, expectedness, reporter’s causality, and overall event resolution.
• Relies upon medical knowledge to conduct comparisons of adverse event source documents against safety database data screens for transcription and medical accuracy.
• Review source documents for accuracy of triage assessment to include case priority, Baxalta Awareness Date and internal and external completion/submission dates.
• Ensure that the correct suspect drug was selected within the Global Safety Database.
• Able to incorporate all relevant medical/clinical information for individual case safety reports into a coherent written narrative.
• Code medical terms using standardized medical dictionaries (such as MedDRA).
• Perform Source Verification quality checks as requested/necessary.
• Using expertise in therapeutic area, to assess data, determine and prioritize follow-up needs.
• Interact with patients, consumers, healthcare providers on a professional peer-to-peer level in order to gather all required medical information, including query generation, tracking, and follow up with reporters in conjunction with local affiliates.
• Create and issue regulatory reports, including individual case safety reports using the Submission Criteria. May also include distribution/submission to affiliates or Regulatory Authorities of ICSRs, as appropriate.
• Take initiative to recognize, prioritize and escalate potential safety/ compliance issues; to include identification, investigation and ownership of corrective action preventative action (CAPAs).
• May participate in risk assessments and signal detection activities for therapeutically aligned products.
• Interact with other GDS functional areas to process adverse events efficiently and reliably.
• Collaborate with relevant counterparts in the regional and country Drug Safety functions to facilitate the global exchange of safety information.
• Interface with other Baxter groups (e.g. Quality, Regulatory, IT, Legal, business units, etc).
• Responsible for completing required training on-time and following established policies.

• RN and/or BSN/ Bachelor’s degree in pharmacy or higher level healthcare professional licensure required
• Broad knowledge of medical and scientific principles of human disease process in conjunction with the intervention of pharmaceutical/biological products.
• Working knowledge of ICH guidelines and other worldwide safety regulations.
• Exposure to relationships with regulatory authorities.
• Previous experience with safety database programs (i.e. ARGUS, Aris-g, etc) desired
• Basic proficiency with MS Word, outlook required; excel, access, powerpoint preferred.
• Medical & clinical knowledge required.
• Excellent analytical & problem solving skills.
• Excellent oral & written communication & interpersonal skills.
• Operates effectively in a team environment.
• Takes personal initiative by proactively identifying work to be accomplished and drives completion of that work.
• Ability to work under strict deadlines and changing priorities with some supervision.
• Able to multitask and prioritize changing workload on a daily basis.
• Ability to establish priorities and proceed with accomplishing objectives.
• Effective organizational skills used in prioritization of deliverables to accomplish work in established timeframes.
• Adapts in a fast- paced, dynamic environment.