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adverse-event-reporting-policy

100 / 100 · Low risk

Fine to try.

By lev-os/agents (GitHub) · research · 28 stars · scanned at commit b247a6d

Drafts an Adverse Event Reporting Policy compliant with 21 CFR 312.32 (IND safety reporting), 21 CFR 314.80 (postmarketing), and ICH E2A, with multi-jurisdictional overlays (EMA, PMDA, Health Canada). Covers seriousness/causality frameworks, expedited reporting timelines, roles, documentation standards, training mandates, and QA mechanisms. Use when drafting or updating an adverse event reporting policy, pharmacovigilance policy, AE/SAE reporting SOP, or safety reporting framework for a pharmac…

Works with any agent that supports SKILL.md skills.

What this skill can do

We found nothing in the files we read that matches our rules. That does not prove the skill is safe: see the limits of static scanning.

Install

Paste this into your terminal. It downloads exactly the version we scanned, not whatever is newest.

if [ -e ~/.agents/skills/'adverse-event-reporting-policy' ] || [ -L ~/.agents/skills/'adverse-event-reporting-policy' ]; then echo 'A skill folder named adverse-event-reporting-policy already exists — not replacing it' >&2; false; else d=$(mktemp -d) && git clone --quiet --filter=blob:none --no-checkout 'https://github.com/lev-os/agents' "$d" && git -C "$d" checkout --quiet 'b247a6df3094b3f2c2780c0f34a9f05925627ffc' -- 'skills-db/legal/adverse-event-reporting-policy' && mkdir -p ~/.agents/skills && cp -R "$d"/'skills-db/legal/adverse-event-reporting-policy' ~/.agents/skills/'adverse-event-reporting-policy' && rm -rf "$d"; fi

Codex reads ~/.agents/skills directly. For Claude Code, Cursor, Copilot, Gemini CLI, Antigravity or OpenCode, also link it. For Claude Code: ln -s ~/.agents/skills/'adverse-event-reporting-policy' ~/.claude/skills/'adverse-event-reporting-policy' (other agents: ~/.cursor/skills, ~/.copilot/skills, ~/.gemini/skills, ~/.gemini/config/skills, ~/.config/opencode/skills). Or install through the finder skill, which does both.

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