Top 20 Global CRO Technical Interview Questions
Master the exact regulatory definitions and clinical scenarios evaluated by interview panels at Novartis, IQVIA, and Parexel.
What Interviewers Are Testing:Checks if candidate knows the foundational regulatory bar for logging an adverse event case in Oracle Argus or safety databases.
High-Scoring Model Answer:
An Individual Case Safety Report (ICSR) is considered valid for triage and regulatory reporting if and only if all 4 minimum elements are present:
1. An Identifiable Patient (initials, age, DOB, gender, or patient ID number).
2. An Identifiable Reporter (name, contact info, healthcare professional qualification, or consumer tag).
3. At least one Suspect Medicinal Product (brand or generic drug name, dose, or batch).
4. At least one Adverse Event or Reaction.
If any one of these four is missing, the case is marked non-valid/potential and assigned for follow-up query generation.
Panelist Pro-Tip:Mention that 'Day 0' (Clock Start) begins the exact calendar day all 4 elements are received by any representative of the marketing authorization holder (MAH).
Keywords:ICH-E2DICSRIdentifiable PatientIdentifiable ReporterDay 0Clock Start
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