Drug Safety Specialist

Case Processing (CT/ PM) – 50% Responsible for processing adverse event reports that include but are not limited to the receipt, evaluation, reviewing and reporting of adverse event information for marketed and investigational products in accordance with ICH guidelines and applicable regulatory requirements including the FDA, company SOPs, and applicable licensing or partnership agreements. Track cases from receipt to closure and work with clinical, regulatory, and contract research organizations (CROs) to ensure all post‑market and clinical safety pharmacovigilance activities are performed across ongoing projects independently. Perform verification of safety data and utilize clinical judgement in coding of verbatim adverse events, medical history, and medications. Ability to synthesize complex clinical information into accurate and complete reports. Actively obtain follow‑up through event resolution. Perform SAE reconciliation, ensuring completeness and closure of cases in a timely fashion. Perform continuous quality improvement initiatives to ensure data consistency across products and a high level of data quality. Contribute to the conduct of ongoing safety surveillance for marketed and investigational products. Assist with the identification and evaluation of events of special interests as well as aggregate data review. Vendor Management Coordination – 25% Act as a safety representative and facilitator between external reporting sources such as call centers, CROs and investigator sites, interfacing with internal departments clinical operations, medical information, regulatory affairs, product development, quality assurance, biostatistics, data management, and legal. Clinical Project Management Coordination – 25% Participate in clinical project teams and other interdepartmental teams supporting clinical studies; review and provide comments on study‑related documents. Other Responsibilities Contribute to the development and writing of industry standard operating procedures and processes for pharmacovigilance activities, including the writing of the Safety Management Plan for assigned studies to ensure the uniform and timely processing of adverse event reports. Assist in responding to queries from health authorities or outside sources; compile and supply as requested, safety information for regulatory submissions such as IND safety reports, Annual Safety Reports, PSUR, or clinical study reports. Other responsibilities as assigned. Basic Qualifications A clinical degree (e.g., RPh/PharmD, BSN, RN) 3-5 years drug safety or clinical safety experience Two years clinical experience in a medical setting, demonstrating general medical and pharmacology knowledge Preferred Qualifications Experience processing Oncology cases Demonstrated knowledge of domestic and international regulatory safety reporting requirements, including FDA/ICH guidance related to pharmacovigilance and Good Clinical Practices Ability to make clinical decisions and formulate appropriate queries based on sound medical knowledge Competence with commercial safety application databases such as Clintrace, ArisG or Argus. Knowledge of clinical trial database (e.g., Trailmaster) is a plus Ability to work effectively as an individual contributor and as project team safety representative Proactive and demonstrate ability to independently identify problems and effectively offer solutions Ability to work independently and multi‑task with attention to detail Excellent interpersonal, communication, and personal organization skills; ability to prioritize workload and work effectively, sometimes within resource constraints Pay Pay ranges between $44-50/hr based on experience. #J-18808-Ljbffr