Moving Science Closer to Health
Safety Specialist II
Location
Serbia
Posted
7 days ago
Salary
0
Seniority
Mid Level
Job Description
Safety Specialist II
Precision Medicine Group
• Process ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans • Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory reportability • Enters data into Argus Safety Database • Code events, medical history, concomitant medications and tests • Draft case narratives • 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 • Participates in audits/inspections as required • 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
Job Requirements
- 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
- 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.
Benefits
- Precision Medicine Group is an Equal Opportunity Employer.
- Reasonable accommodation to complete application process.
- Collaboration with global teams.
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