<h3>Position Summary: </h3><p>The <strong>Safety Specialist II </strong>is an integral part of the safety team at Precision and performs all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR) for clinical trials and/or post-marketing safety programs. </p><p><strong>Essential functions of the job include but are not limited to:</strong></p><ul><li>Process ICSRs according to Standard Operating Procedures (SOPs) and project/program- specific safety plans </li><li>Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability </li><li>Enters data into Argus Safety Database </li><li>Code events, medical history, concomitant medications and tests. </li><li>Draft case narratives </li><li>Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved </li><li>Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements </li><li>Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases </li><li>Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects </li><li>Participate in audits/inspections as required </li><li>Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate </li><li>Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process </li><li>Attends Department meetings </li><li>Participates in project specific teleconferences/meetings as required </li><li>Other duties assigned by management </li></ul><h3>Qualifications: </h3><h3>Minimum Required: </h3><ul><li>Minimum 2 years of experience in clinical trial drug safety in the Pharma/CRO industry </li><li>Bachelor’s or first-level Degree in Pharmacy or Nursing preferred, but other Life Science, or other health-related field, or equivalent qualification.  Immuno-oncology and Advanced Therapy Medicinal Products experience a plus. </li><li>Experience with Oracle Argus Safety Database </li><li>Working knowledge of MedDRA and WHODrug </li><li>Working knowledge of FDA safety regulations, EMA.MHRA and other ICH guidelines, and global safety regulations </li></ul><div class="content-conclusion"><hr><p>Any data provided as a part of this application will be stored in accordance with our <a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fprivacy-policy%2F&amp;data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUn