Pharmacovigilance

Prompts to draft regulatory documents, analyze drug safety data, and generate reports for health authorities.

Prompt Sample

Prompt ID	Prompt Text	Difficulty Level	Target User	Use-Case Tags
REGULATORY DOCUMENT DRAFTING (1-40)
PV-REG-001	Draft an Expedited Safety Report (ESR) for a Suspected Unexpected Serious Adverse Reaction (SUSAR) based on the following case details: [Insert Case Narrative, including patient demographics, event details, timing, outcome, and investigator’s causality assessment]. Format according to ICH E2B(R3) requirements.	Advanced	Drug Safety Associate	#SUSAR #Expedited_Reporting #ICH_E2B
PV-REG-002	Generate the executive summary for a Periodic Benefit-Risk Evaluation Report (PBRER). Summarize the reporting interval, exposure, important safety findings, new risks, and overall benefit-risk conclusion.	Advanced	PV Physician / Medical Writer	#PBRER #Executive_Summary #Benefit_Risk
PV-REG-003	Create a template for a Development Safety Update Report (DSUR) that includes all standard sections as per ICH E2F guideline, with placeholders for data.	Intermediate	PV Manager	#DSUR #Template #ICH_E2F
PV-REG-004	Draft a “Dear Healthcare Professional” communication letter regarding a new important identified risk of [e.g., Hepatotoxicity] for the drug [Drug Name].	Intermediate	PV Physician / Regulatory Affairs	#DHPC #Risk_Communication #Physician

DRUG SAFETY DATA ANALYSIS (41-70)
PV-DA-041	Calculate the reporting rate (cases per 100,000 patient-years) for the event of [e.g., Rhabdomyolysis].	Intermediate	PV Epidemiologist / Analyst	#Reporting_Rate #Incidence
PV-DA-042	Perform a disproportionality analysis (e.g., calculate the Proportional Reporting Ratio – PRR) for [Drug-Event Pair] using the FDA Adverse Event Reporting System (FAERS) data subset.	Advanced	PV Data Scientist	#Disproportionality_Analysis #PRR #Data_Mining
PV-DA-043	Analyze the time-to-onset profile for the event of [e.g., Stevens-Johnson Syndrome]. Calculate the median and interquartile range.	Advanced	PV Epidemiologist	#Time-to-Onset #Analysis

HEALTH AUTHORITY REPORT GENERATION (71-100)
PV-HA-071	Generate the final approved PBRER/PSUR and prepare it for submission in the required eCTD (electronic Common Technical Document) format.	Advanced	Regulatory Operations Specialist	#eCTD #PBRER_Submission #Formatting
PV-HA-072	Draft the cover note for a Variation application to update the product label based on new safety data.	Intermediate	Regulatory Affairs Specialist	#Variation_Application #Labeling_Update
PV-HA-073	Generate a list of all required periodic safety reports (PSURs/PBRERs) and their due dates for the upcoming year for the entire product portfolio.	Intermediate	PV Planning Manager	#Reporting_Calendar #Planning
PV-HA-074	Draft the response to an FDA 15-day Alert report.	Advanced	PV Physician / Regulatory Affairs	#FDA_15Day_Alert #Response

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