Responsibilities
- Process individual case safety reports in compliance with standard operating procedures and study-specific safety protocols
- Assess incoming reports to determine completeness and regulatory reporting requirements
- Input safety data accurately into the Argus Safety system
- Code adverse events, medical histories, concomitant medications, and diagnostic tests using standardized terminology
- Prepare detailed case narratives summarizing safety events
- Resolve data queries through follow-up activities until all information is complete
- Produce and submit expedited regulatory safety reports within required timelines
- Collaborate to align safety and clinical trial databases for consistency
- Ensure proper distribution of mandatory safety documentation
- Support regulatory audits and inspections as needed
- Upload required documents to the Trial Master File or Pharmacovigilance Master File
- Maintain adherence to SOPs, Good Clinical Practice, ICH guidelines, and pharmacovigilance standards
- Attend regular team and departmental meetings
- Engage in project-specific meetings with cross-functional teams
- Perform additional tasks as directed by management
Requirements
- Minimum of two years of experience in clinical trial drug safety monitoring
- Bachelor’s degree in Pharmacy, Nursing, Life Sciences, or a related field
- Hands-on experience with Argus Safety Database, MedDRA, WHODrug, and global safety regulations (FDA, EMA, ICH)
- Proficient in professional English communication
Nice to Have
- Experience in early-phase oncology trials is advantageous
Responsibilities
- Process ICSRs according to SOPs and project-specific safety plans
- Triage ICSRs, evaluates data for completeness and regulatory reportability
- Enter data into Argus Safety Database
- Code events, medical history, concomitant meds, and tests
- Draft case narratives
- Query resolution and follow-up until complete
- Generate timely expedited regulatory reports
- Coordinate reconciliation of safety and clinical databases
- Ensure required safety reports distribution
- Participate in audits/inspections
- Submit documents to TMF/PV System MF
- Maintain compliance with SOPs, GCP, ICH, GVP, regulations
- Attend department meetings
- Participate in project meetings
- Other duties as assigned
Required
- Minimum 2 years clinical trial drug safety experience
- Bachelor’s degree in Pharmacy, Nursing, Life Science, or equivalent
- Experience with Argus Safety Database, MedDRA, WHODrug, FDA/EMA/ICH safety regulations
- Professional working proficiency in English
Preferred
Early phase oncology experience preferred
