Senior Specialist, Global ICSR Management
New
J
JobgetherPharmaceutical, Pharmacovigilance
BrazilFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- At least 2 years of experience in drug safety, pharmacovigilance, or relevant clinical activities
- Required Skills
- Data AnalysisGCPMicrosoft ExcelPowerPoint
Requirements
- Bachelor’s degree in life sciences, medicine, nursing, pharmacy, or equivalent.
- At least 2 years of experience in drug safety, pharmacovigilance, or relevant clinical activities.
- Working knowledge of global pharmacovigilance and regulatory requirements (ICH, GVP, FDA, GCP, NMPA/CDE).
- Understanding of ICSR case-processing including intake, triage, medical coding, and narrative development.
- Proficiency with pharmacovigilance databases (Argus Safety preferred).
- Fluent in English (verbal and written).
- Strong time-management skills and ability to meet strict regulatory deadlines.
- Proficiency with Microsoft Office tools (Excel, PowerPoint).
- Strong analytical and problem-solving abilities with high attention to detail.
Responsibilities
- Independently perform ICSR triage, case processing, and quality control.
- Manage safety cases from clinical trials, post-market sources, and literature.
- Perform SAE reconciliation between safety and clinical databases and resolve discrepancies.
- Meet quality, compliance, productivity, and volume KPIs within reporting timelines.
- Support ICSR-related activities involving vendors and CROs per pharmacovigilance agreements.
- Contribute to process improvement initiatives within global ICSR management.
- Deliver training, develop materials, and support onboarding for new team members.
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