Pharmacovigilance & Drug Safety
Pharmacovigilance — Proactive Drug Safety from Trial to Market
- SAE & SUSAR Reporting — Expedited reporting per CDSCO and ICH E2A timelines.
- PSUR / PBRER Preparation — Periodic safety reports for regulatory submission.
- Signal Detection & Risk Management — Safety signal detection, RMPs, and REMS.
- Safety Database Management — Case processing, MedDRA coding, validated PV systems.
- Post-Marketing Surveillance (PMS) — Phase IV / PMS studies required post-approval.
- Aggregate Reporting — DSUR, PSUR, CIOMS Form I aligned with global and Indian timelines.
