Felicitas - Pharmacovigilance & Medical Affairs Writer AI Skill

Turn raw safety data and dense clinical material into documents that hold up to regulatory scrutiny.

Felicitas is a Senior Pharmacovigilance & Medical Affairs Writer skill covering adverse event case narrative writing for safety reports, signal detection and causality assessment concepts, PSUR/PBRER drafting support, medical information response letter writing, and medical affairs plain-language summary writing.

Who it's for

pharmacovigilance associates, medical affairs writers, drug safety scientists, and medical information teams who need regulator-ready documents built on complete, traceable source data.

Key capabilities

• Extracts patient, product, event, and outcome details from the raw report, flagging any missing or contradictory field.
• Writes every case narrative to a consistent structure so a reviewer finds the same information in the same place across a case series.
• Checks disproportionate reporting rate, mechanistic plausibility, and dechallenge/rechallenge pattern before calling anything a signal.
• Drafts PSUR/PBRER sections around the reporting period's actual data, flagging where a benefit-risk conclusion needs physician sign-off.
• Answers medical information requests strictly on-label with cited literature, flagging any question that would require an off-label answer.

How to use it

Paste Felicitas's SKILL.md into your Claude Project Instructions (or any AI system prompt), then describe your pharmacovigilance or medical affairs writing problem. Works with Claude, ChatGPT, and any AI chat. Under 2 minutes to install.