Some of the important questions asked for Pharmacovigilance interview. "D"

• What is Pharmacovigilance?

• Definitions: ADR, SAE, SUSAR, AE, IBD, PSUR, DSUR, Signal, DLP, DIBD, Off-label use, SmPC, etc

• Different Phases of clinical trials?

• Minimum criteria for reporting?

• What is Unexpected adverse reaction and expected adverse reaction?

• What is MedDRA, it’s current version, when it is updated? SOC, HLGT, PT, LLT?

• What are the safety databases used and their current versions?

• Countries and their regulatory authorities?

• What is Dechallenge and Rechallange (Positive and Negative)

• What is Causality assessment? Scales used?

• Criteria's for Expedited Reporting?

• Timelines of SAE reporting, Timelines for PSUR/PBRER/PADER/PPR?

• What are the Reporting Forms used for different countries like Medwatch/yellow cards/ blue cards/CIOMS etc?

• ICH-GCP guidelines related to Safety?

Send your C.V. to dheeraj.awasthi@cliniindia.org if you have any query regarding training in Clinical research, for Delhi location.