0 - 2 years
0 Lacs
Posted:1 day ago|
Platform:
On-site
Full Time
Collect, evaluate, and process adverse event (AE) and serious adverse event (SAE) reports from various sources (clinical trials, literature, healthcare professionals, patients).
Perform case processing including data entry, coding (using MedDRA/WHO-DRL), and narrative writing in the safety database.
Ensure compliance with regulatory timelines (e.g., 15-day or 7-day expedited reporting).
Conduct quality checks on case reports to ensure accuracy and completeness.
Assist in preparation of Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs).
Monitor literature and scientific publications for potential safety signals.
Support signal detection and analysis activities.
Maintain up-to-date knowledge of pharmacovigilance regulations and company SOPs.
Collaborate with cross-functional teams including clinical research, regulatory affairs, and medical writing.
CLARIWELLGLOBAL SERVICES LLP
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