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Safety Specialist II
Precision Medicine GroupSafety Specialist II managing safety reports for clinical trials. Integral part of the safety team at Precision Medicine Group, handling data for clinical trials and safety programs.
Tech Stack
Tools & technologiesOracle
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- 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
Comp & perks- Precision Medicine Group is an Equal Opportunity Employer.
- Reasonable accommodation to complete application process.
- Collaboration with global teams.
ATS Keywords
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Hard Skills & Tools
Data EntryEvent CodingCase Narrative DraftingRegulatory Reportability EvaluationData Reconciliation
Certifications
Bachelor’s Degree in PharmacyBachelor’s Degree in Nursing