From this below article we uncover essential insights in the realm of Medical review role in pharmacovigilance!
- Explore the significance of medical review
- Unravel the crucial responsibilities attached to this role, and discover who qualifies for this vital position.
- Delve into the challenges faced in this pivotal role
Table of Contents:
- Purpose of Medical Review
- Eligibility For This Role
- Responsibilities
- Challenges in Medical Review
- Unforeseen Tip
- Thoughts
- FAQ
Purpose of Medical Review
The Medical review within the pharmacovigilance department serves a critical purpose: to meticulously ensure the accuracy of information and analyze data from the source.
Their vital role unfolds in two key areas — firstly, during the initial case triage, as detailed in our article on the Importance of Case Triage, and secondly, by providing expert comments following the final analysis before archiving.
Their expertise forms the backbone of our data integrity and analysis processes.
Your road-map to meticulous and comprehensive medical evaluation. Explore in deep with us.
Eligibility for This Role
ICH-GCP does not define or describe the responsibilities of a medical monitor. A practical definition might be a physician or other qualified individual, separate from the principal investigator, who is responsible for medical and safety monitoring of research subjects.
Primarily, licensed healthcare professionals include individuals such as doctors (safety physician) who have practiced medicine during their studies.
Additionally, pharmacists or nurses with extensive expertise in the field of pharmacovigilance, coupled with a robust background in medical analysis and evaluation, also fall within this category and analytical skills, and regulatory knowledge is crucial for this role.
Responsibilities:
Unraveling the Essence of Medical Review:
- 🆗 Confirming received medical information
- 🕵️ Detecting causal relationships (Learn more…)
- 📊 Analysing new signals
- 👩⚕️ Distinguishing medical conditions from AE/ADR (Learn more…)
- 📝 Analysing narrative details (Learn more…)
- 🔍 Identifying necessary additional information
- 🗣️ Providing expert comments and case recommendations
- 📌 Spotting missing information
- ✅ Confirming the relevance of coding (Learn more…)
- 🔄 Identifying the potential alternative cause
- ⚖️ Assessment of seriousness
Challenges in Medical Review
Causality assessment:
Identifying complicated, unresolved situations in medical cases without proper validation is a challenging task in ICSR medical reviews.
Handling Complex Cases:
An example:
An instance where a medical reviewer is indispensable occurs when a case is reported by a consumer. While retaining the consumer’s description of the event is crucial, it is equally important to seek and incorporate confirmatory or additional information from relevant healthcare professionals.
However, clearly identified evaluations by the MAH are considered appropriate and are required by some regulatory authorities.
Unforeseen Bonus Tip:
You might wonder why non-serious cases do not undergo medical review. While regulations do not explicitly state that non-serious cases are exempt from medical review, the reason could be that only serious cases are submitted to authorities and taken into consideration. In fact, some references declared that non-serious cases are not even submitted to the FDA.
Final thoughts
If you have a keen interest in the medical review role in pharmacovigilance, begin evaluating case files and delve into understanding the decision-making process starting today.
“Have I omitted any vital aspects of this role? Share your thoughts in the comments if there’s anything I overlooked.”
FAQ:
Who are medical reviewers?
What is the purpose of Medical review in Pharmacovigilance?
Who are eligible to Medical reviewer role in pharmacovigilance?
2. Other qualified individual, separate from the principal investigator
3. Pharmacists or nurses with extensive expertise in the field of pharmacovigilance
What are the responsibilities of Medical reviewer role in pharmacovigilance?
2. Detecting causal relationships (Learn more…)
3. Analysing new signals
4. Distinguishing medical conditions from AE/ADR (Learn more…)
5. Analysing narrative details (Learn more…)
6. Identifying necessary additional information
7. Providing expert comments and case recommendations
8. Spotting missing information
9. Confirming the relevance of coding (Learn more…)
10. Identifying the potential alternative cause
11. Assessment of seriousness
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