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.