Related skills
gcp ich guidelines pharmacovigilance fda gvp📋 Description
- Review and transmit ICSR safety reports to regulators and partners.
- Maintain submission trackers and distribution lists.
- Generate final regulatory reports from the safety database.
- Prepare and distribute submission documents, including Investigator Safety Letter.
- Perform case closure and electronic filing of SAE documentation.
- Monitor regulatory intelligence and support Safety Reporting Plans.
🎯 Requirements
- Knowledge of FDA, ICH, and EU pharmacovigilance regulations.
- Experience with ARGUS Safety Database.
- Minimum 2 years in clinical trial drug safety in Pharma/CRO.
- Experience with EMA EudraVigilance, UK MHRA, and other portals.
- BA/BS degree preferred.
- Strong documentation, data management, and regulatory compliance skills.
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