Safety Specialist I

As a Safety Specialist I at Precision, your role will involve performing all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR) for clinical trials and/or post-marketing safety programs. Key Responsibilities: - Process ICSRs following Standard Operating Procedures (SOPs) and project/program-specific safety plans - Triage ICSRs, evaluate data for completeness, accuracy, and regulatory report ability - Enter data into Argus Safety Database - Code events, medical history, concomitant medications, and tests - Draft case narratives - Assess information to be queried and follow up until queries are satisfactorily resolved - Generate timely, consistent, and accurate expedited reports in line with regulatory requirements - Coordinate with data management staff for safety data reconciliation - Ensure distribution of all required individual expedited and periodic reports for clinical and post-marketing projects - Participate in audits/inspections - Submit all relevant documents to Trial Master File (TMF) and Pharmacovigilance System Master File - Maintain understanding and compliance with SOPs, regulations, guidelines, and project plans - Attend department meetings and project-specific teleconferences/meetings - Perform other duties as assigned by management Qualifications: Minimum Required: - Minimum 2 years of clinical trial drug safety experience in the Pharma/CRO industry - Bachelors or first-level Degree in Pharmacy or Nursing preferred - Experience with Oracle Argus Safety Database - Working knowledge of MedDRA, WHODrug, FDA safety regulations, EMA, MHRA, ICH guidelines, and global safety regulations Preferred: - Early phase oncology clinical trial experience Please note that any data provided will be stored as per the company's Privacy Policy. For CA applicants, refer to the CA Privacy Notice. If you require accommodation for the application process, kindly contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.,