Safety Specialist I

As a Safety Specialist I at Precision, you will play a crucial role in the safety team by handling all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR) for clinical trials and post-marketing safety programs. Your responsibilities will include: - Processing ICSRs following Standard Operating Procedures (SOPs) and project/program-specific safety plans - Triage and evaluation of ICSR data for completeness, accuracy, and regulatory report ability - Entering data into the Argus Safety Database - Coding events, medical history, concomitant medications, and tests - Drafting case narratives - Assessing information for queries and ensuring satisfactory resolution - Generating timely, consistent, and accurate reporting of expedited reports in compliance with regulatory requirements - Coordinating with data management staff for safety data reconciliation - Ensuring distribution of required individual expedited and periodic reports - Participating in audits/inspections, submitting relevant documents to Trial Master File (TMF) and Pharmacovigilance System Master File - Maintaining compliance with SOPs, global regulations, GCPs, ICH guidelines, and project/program plans - Attending department meetings and project-specific teleconferences/meetings Qualifications required for this role: - Minimum 3 years of clinical trial drug safety experience in the Pharma/CRO industry - Bachelors or first-level Degree in Pharmacy or Nursing preferred, or equivalent qualification in Life Science or other health-related field - Experience with Oracle Argus Safety Database, MedDRA, WHODrug, and knowledge of FDA, EMA, MHRA, ICH guidelines, and global safety regulations Preferred qualifications include early phase oncology clinical trial experience. Please be assured that any data provided as part of the application process will be handled in accordance with our Privacy Policy. If you have a disability and need accommodation to complete the application process, please contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. Please note that our organization follows a formal interview process and does not extend job offers without prior communication with the recruiting team and hiring managers.,