Felicitas - Medical Affairs Writer AI Skill

Name: Felicitas - Medical Affairs Writer AI Skill
Brand: KissMySkills
Price: 29.0 USD
Availability: InStock

Felicitas - Pharmacovigilance & Medical Affairs Writer Claude skill by KissMySkills, hardcover volume cover

$29.00

$29.00 $43.99

Felicitas - Medical Affairs Writer AI Skill

$29.00 this skill vs $43.99 hiring a pharmacovigilance writer

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

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Choose how to get it

Buy once $29 This one skill as a file. Yours forever, works in any AI chat. All-Access whole library $8.25/mo billed yearly All 1,000+ skills in the marketplace. Your AI picks the right one and loads it by itself. Claude, ChatGPT, Claude Code, Cursor · or $19 month to month

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⚡ Instant download ∞ Keep forever ✎ Written by us

Add it once. Your AI works like a specialist.

Add it to Claude, ChatGPT or Gemini - your AI works as a specialist in this field.

Instant download · 30-day money-back guarantee. Pay once, keep forever - no subscription. Written and tested by us, never scraped from GitHub. Refund policy

Ask Felicitas something hard.

📎 felicitas-pharmacovigilance-medical-affairs-writer.md LOADED ✓

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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You don't read it. Your AI does.

Add the skill file to Claude, ChatGPT or Gemini once. From then on it works as a specialist in this field and answers as Felicitas from the very next message.

Buy once and the file is yours to keep forever. Or subscribe to All-Access and let the KissMySkills connector load it, and every other skill, into your chat on request.

// 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.

A senior pharmacovigilance and medical affairs writer bills $150+/hr for a PSUR section and case narrative, the complete skill is yours forever.

// what's inside

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 file anywhere on your device.
02
Open your AI chat
Claude, ChatGPT, Gemini, Grok, or Copilot - whichever one you already use.
03
Paste the file contents
Drop it into the system prompt, Project instructions, or custom instructions field.
04
Start working
Your AI is now configured as a specialist. Ask it anything inside its domain.

No technical knowledge required. No subscription. Pay once, keep forever.

// compatible with

Works with every major AI chat.

Drop the file into your AI's system prompt, Project instructions, or custom instructions. No setup. No code. No vendor lock-in.

// 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.

Do I have to read it myself?+

No. The file is written for your AI to read, not for you. Upload it or paste it in once and the AI takes on the role. After that you just ask it questions the way you normally would. You're welcome to open it and read it, but nothing here depends on you doing that.

Is this a physical book?+

No, it's digital. You download it the moment the order goes through and it's yours permanently. The cover is styled like a book because each edition is written and edited as one self-contained piece of work. The reading part is your AI's job, not yours.