The Safety Specialist 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.
Essential functions of the job include but are not limited to:
- Process ICSRs according to Standard Operating Procedures (SOPs) and project/program- specific safety plans.
- Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
- Enters data into Argus Safety Database
- Code events, medical history, concomitant medications and tests.
- Draft case narratives
- Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
- Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
- Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases
- Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects.
- Participate in audits/inspections as required
- 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.
- 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.
- Attends Department meetings.
- Participates in project specific teleconferences/meetings as required.
- Other duties assigned by management
Qualifications:
Minimum Required:
- Minimum 2 years of experience in clinical trial drug safety in the Pharma/CRO industry
- 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.
- Experience with Oracle Argus Safety Database
- Working knowledge of MedDRA and WHODrug
- Working knowledge of FDA safety regulations,EMA.MHRA and other ICH guidelines, and global safety regulations.
Preferred:
- Early phase oncology clinical trial experience
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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC
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