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Adverse Event Reporting Policy Drafter

CaseMarkbyCaseMark
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44
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Content Management

Drafts comprehensive, regulatory-compliant adverse event reporting policies for pharmaceutical, biotech, and clinical research organizations.

This skill assists regulatory and clinical affairs professionals in generating binding Adverse Event (AE) reporting policies that meet stringent FDA and ICH standards. It provides a structured framework for defining seriousness criteria, establishing expedited reporting timelines (7/15-day), assigning organizational roles, and implementing multi-jurisdictional overlays for global operations. By ensuring all critical compliance components—from causality assessment algorithms to QA mechanisms—are included, the skill streamlines the creation of SOPs and safety frameworks for IND products, medical devices, and postmarketing surveillance.

Key Features

01Automated expedited reporting timeline templates
02Detailed documentation and record retention standards
03Standardized seriousness and causality assessment frameworks
0435 GitHub stars
05Multi-jurisdictional compliance (FDA, EMA, PMDA, Health Canada)
06Role-based responsibility mapping for PV and clinical teams

Use Cases

01Drafting a new Pharmacovigilance SOP for a biotech startup
02Updating existing safety reporting frameworks for international clinical trials
03Establishing binding safety reporting policies for CROs and sponsors