Felicitas - Medical Affairs Writer AI Skill

Name: Felicitas - Medical Affairs Writer AI Skill
Brand: KissMySkills
Price: 19 USD
Availability: InStock

Medical Affairs Writer, Felicitas AI skill by KissMySkills, cover

Felicitas - Medical Affairs Writer AI Skill

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

$19 this skill one payment yours forever

Claude skill package instant downloadfelicitas-pharmacovigilance-medical-affairs-writer.skill

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How it works

Ask Felicitas something hard.

📎 felicitas-pharmacovigilance-medical-affairs-writer.skillLOADED ✓

Turn six months of adverse event reports into the safety section of our periodic regulatory report.

CLAUDE · AS FELICITAS, MEDICAL AFFAIRS WRITER Felicitas returns: a signal assessment drawn from the raw safety data → a case narrative set written to regulatory standard → a periodic report safety section → a reviewer-ready benefit-risk summary.

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Questions before you buy? A person answers, usually the same day: hello@kissmyskills.com

// the file itself

Read it before you buy it.

The first lines of the file your AI will read, exactly as delivered. Nothing rewritten for the page.

// the skill your AI runs on

You are Felicitas, a Senior Pharmacovigilance and Medical Affairs Writer who structures a case narrative and walks causality through WHO-UMC or Naranjo criteria. You have been activated to draft safety documents a reviewer can act on.

Drop Felicitas into Claude and get a Senior Pharmacovigilance & Medical Affairs Writer who turns raw safety data and dense clinical material into documents that hold up to regulatory and clinical scrutiny. Felicitas does not treat case narrative writing as paperwork. She treats it as the record a regulator, a safety committee, or a healthcare provider will actually read and act on: a vague narrative buries a real signal, a rushed causality call undermines the whole safety report, and a medical information letter that drifts off-label creates regulatory exposure the requester never intended. Felicitas covers five areas: adverse event case narrative writing for safety reports, signal detection and causality assessment concepts, periodic safety update report (PSUR/PBRER) drafting support, medical information response letter writing for healthcare provider inquiries, and medical affairs slide/publication plain-language summary writing. Felicitas never writes a safety document before she understands what

SKILL.md · 197 lines · instant download

// what's inside

What's inside this skill

Signal assessment drawn from the raw safety data
Case narrative set written to regulatory standard
Safety section drafted for the periodic report
Benefit-risk summary written for a regulatory reviewer

Pharmacovigilance staff, medical writers and regulatory teams facing a reporting deadline.

// two ways to get it

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Library plan

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Trademarks of their respective owners. KissMySkills is not affiliated with or endorsed by them.

// ask your assistant

Or let your AI set up this skill for you.

Go to kissmyskills.com/pages/connector and set up the "Felicitas - Medical Affairs Writer AI Skill" skill (handle: felicitas-pharmacovigilance-medical-affairs-writer) for me

Paste it into Claude, ChatGPT, Claude Code, Cursor or Codex. Your AI walks you through connecting KissMySkills (about 3 minutes, 7-day free trial) and loads the skill. What your AI will read →

What you're actually buying

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.

// how to install Under 2 minutes

Four steps. Any AI chat.

01
Download the file
After checkout, the download link lands in your inbox. Save the .skill file: Claude takes it as it is.
02
Open your AI chat
Any AI chat you already use: Claude, ChatGPT, Gemini, Grok, Copilot or another.
03
Add it to your AI
Claude: Settings → Capabilities → Skills, upload the .skill file. ChatGPT, Gemini and others: open the .skill file like a .zip archive and paste SKILL.md into custom instructions or Project instructions.
04
Start working
Your AI is now configured as a specialist. Ask it anything inside its domain.

No technical knowledge required.

With Library there is nothing to download. Connect your AI once, then just ask: "Load Felicitas from KissMySkills."

Setup guide → Library · $9/mo →

// faq

Questions about this product

What AI tools does this work with?+

Any AI chat that accepts custom instructions - Claude, ChatGPT, Gemini, and others. Paste the SKILL.md content into your project instructions or system prompt.

How do I install it?+

Download the file, paste its full contents into your AI's custom instructions, project instructions, or system prompt field. Takes under 2 minutes.

Is this a course or a tool?+

It's a tool - a structured expert persona and workflow, not a video course. You use it immediately by pasting it into your AI chat.

Which causality framework does Felicitas use for a case narrative?+

She states which named framework is in use - WHO-UMC categories or the Naranjo algorithm - and walks the case through its actual criteria, flagging that the final causality determination of record belongs to a qualified pharmacovigilance physician.