You will get Safety Narrative Review or Writing
Project details
I offer expert-level review or writing of safety narratives, based on real-world inspection experience. This service is ideal for:
Sponsors preparing for submission
CROs under pressure
Startups needing help for one-off SAE or SUSAR narratives
You’ll get a high-quality narrative that’s medically accurate, clear, and inspection-ready.
Options:
✔ Review: I’ll provide tracked edits and commentary on an existing draft
✔ Review plus writing of analysis of similar events (AOSE): I’ll provide tracked edits and commentary on an existing draft plus AOSE
✔ Write-Up: You send the source documents or case summary, and I draft the full narrative
I’ve written and reviewed thousands of narratives in my time in safety and pharmacovigilance including as Global QPPV and Head of Safety.
Sponsors preparing for submission
CROs under pressure
Startups needing help for one-off SAE or SUSAR narratives
You’ll get a high-quality narrative that’s medically accurate, clear, and inspection-ready.
Options:
✔ Review: I’ll provide tracked edits and commentary on an existing draft
✔ Review plus writing of analysis of similar events (AOSE): I’ll provide tracked edits and commentary on an existing draft plus AOSE
✔ Write-Up: You send the source documents or case summary, and I draft the full narrative
I’ve written and reviewed thousands of narratives in my time in safety and pharmacovigilance including as Global QPPV and Head of Safety.
Subject
Academia, Business, Medical & Pharmaceutical, NonprofitLanguage
EnglishWhat's included
| Service Tiers |
Starter
$50
|
Standard
$100
|
Advanced
$150
|
|---|---|---|---|
| Delivery Time | 2 days | 2 days | 2 days |
Number of Revisions | 0 | 0 | 0 |
Additional Research | - | - | - |
Client Interviews | - | - | - |
References & Citations | - | - | - |
Design | - | - | - |
Optional add-ons
You can add these on the next page.
24 hour turn around
+$50
1 review
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ML
Martin Alexander L.
Feb 3, 2026
Pharma/Clinical Expert Needed for Feedback on Trial Summary Tool
Lisa is extremely knowledgeable in everything about clinical drug development and clinical operations. A real star.
About Lisa
Senior Pharmaceutical Physician | Global Safety & Clinical Development
Barcelona, Spain - 7:34 pm local time
I now work as a consultant, supporting biotechs, CROs, and health tech companies who need fast, expert-level input without hiring full-time staff. I step in when internal teams need help — whether it’s a signal assessment, an inspection, or a key document that must be ready now.
Why I’m on Upwork:
I’ve built a consulting practice focused on short-term, high-impact support. I’m not between jobs — I’m available on demand for clients who need real expertise and fast answers.
Areas of Expertise:
✔ Safety and benefit–risk strategy
✔ EMA/FDA submissions & regulatory responses
✔ Pharmacovigilance system setup & QPPV support
✔ Inspection readiness and audit rescue
✔ Medical review: protocols, IBs, CSRs, narratives
✔ SOP development (safety, clinical, medical)
✔ Signal detection (incl. EMA ESI) and risk minimization
I also offer one-off strategic calls or document reviews — ideal for early-stage companies or those building their first safety system.
📍 Based in Spain | Available globally | Fast turnaround, clear deliverables, and senior-level clarity
Let’s talk if you need urgent expert support or a reliable partner for a complex challenge.
Steps for completing your project
After purchasing the project, send requirements so Lisa can start the project.
Delivery time starts when Lisa receives requirements from you.
Lisa works on your project following the steps below.
Revisions may occur after the delivery date.
Review the case documents and client instructions
Write or edit the narrative (based on project type)