Safety Review Specialist
Safety Review Specialist - Deerfield, IL
Safety Review Specialist Clinical Research Every day, Kelly Scientific Resources (KSR) connects clinical research professionals with opportunities to advance their careers. We currently have an exciting contract opportunity for a Safety Review Specialist for our client located in Deerfield, IL. Job Responsibilities (other duties may be assigned): This position is a member of the Safety Operations team within Global Pharmacovigilance and serves as a case owner for adverse events to ensure timely and accurate review, processing, and reporting. Responsibilities include, but are not limited to the following: May perform initial triage of source documents for duplicate check within the Global Safety Database, case priority, Client Awareness Date, and closure/submission timeline. Review source documents for accuracy of triage assessment to include case priority, Client Awareness Date and internal and external completion/submission dates. Perform initial safety review of adverse events to determine seriousness, expectedness, reporter?s causality, and overall event resolution. Ensure that the correct suspect drug was selected within the Global Safety Database. Write narratives summarizing all relevant medical information for individual case safety reports. May write Pharmacovigilance PV comment for non-serious cases with guidance from Medical Reviewers. 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. Request case investigation 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. May participate in risk assessments and signal detection activities for therapeutically aligned products. Interact with other GPV functional areas to process adverse events efficiently and reliably. Collaborate with relevant counterparts in the regional and country Pharmacovigilance functions to facilitate the global exchange of safety information. Perform case cleanup as required for preparation of aggregate Reports. Interface with other client groups e.g. Quality, Regulatory, IT, Legal, business units, etc. May participate in literature review activities related to adverse event reporting with oversight from Literature Team reviewers. Perform Source Verification quality checks as requested/necessary. Serve on departmental committees and projects as needed. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Requirements: BS in nursing or pharmacy (or equivalent) with pharmaceutical industry experience. Preferred experience in safety or regulatory departments and 2-3 years of experience in hospital, patient care, or equivalent. Medical clinical knowledge. Excellent analytical problem solving, oral written communication and interpersonal skills. Operates effectively in a team environment. Ability to work under strict deadlines and changing priorities with some supervision. Able to multitask and prioritize changing workload on a daily basis. Working knowledge of ICH guidelines and other worldwide safety regulations. Ability to establish priorities and proceed with accomplishing objectives. Ability to establish proficiency working with a Global Safety Database. Exposure to relationships with regulatory authorities. Strategic Planning and Problem Solving: Work with next level management to plan and implement processes. Product/Process Quality Standards: Maintain currency and compliance with regulatory procedures and systems Risk Assessment and Contingency Planning: Facilitate the identification of risk elements for specific projects to get early indication of area. For immediate consideration, click the ?Apply Now? button, or refer a friend by clicking the E-mail this job link provided. Kelly Scientific Resources® has grown into a $270 million global business as the scientific business unit of Kelly Services. Our recruiting consultants place clinical, regulatory and medical affairs, data management and biostatistics professionals to the pharmaceutical, biotechnology, medical device, CRO and university research communities. We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyscientific.com . Kelly Services is an Equal Opportunity Employer.