WHO THIS PROGRAM IS FOR
B.Pharm / M.Pharm / MSc / BSc Life Sciences
Freshers + 0–3 yrs experience
Career switchers into PV / Compliance roles
Working pharma professionals stuck at ₹3–6 LPA
JOB ROLES THIS PROGRAM TARGETS
Drug Safety Associate
Pharmacovigilance Executive
PV Case Processor
Junior Compliance Analyst
PROGRAM STRUCTURE (12 WEEKS – GOLD STANDARD)
TRAINER PROFILE
Our Vetted Trainers comes MNC’s and reputed Pharma companies , bring their vast experience and real time Job skills for you to get up to speed.
- 8–15 yrs pharma / CRO experience
- Ex‑IQVIA / Novartis / Dr Reddy’s / Syngene / Parexel
Compliance Foundations (Weeks 1–3)
Outcome: Regulatory mindset
- Pharma product lifecycle
- USFDA, EMA, ICH overview
- GxP fundamentals (GVP, GCP, GMP)
- Ethics, patient safety & risk
- How inspections really happen
Core Pharmacovigilance (Weeks 4–6)
Outcome: Job‑ready PV execution
- ICSR case intake & processing
- MedDRA & WHO‑DD coding
- Seriousness, causality, expectedness
- Aggregate reports (PSUR, PBRER – overview)
- Signal detection basics
Compliance & Inspection Readiness (Weeks 7–9)
Outcome: ApexEdge Unique Offering
- SOP writing & review lab
- Deviation, CAPA & change control
- FDA 483 & warning letter analysis
- Data integrity (ALCOA+)
- Mock USFDA audit simulation
Tools, Career & Placement Readiness (Weeks 10–12)
Outcome: Job-Readiness builder weeks
- Argus / Safety DB exposure (screenshots + workflows)
- Resume & LinkedIn (pharma‑specific)
- Interview Q&A (FDA‑style questions)
- Compliance mindset interview training
- Final Capstone Project
Capstone Project:
End‑to‑end Drug Safety Case + Compliance Documentation.
CERTIFICATION-Award Ceremony
ApexEdge Certified Drug Safety & Compliance Professional
COMPLIANCE LAB
Includes:
- Mock FDA audit room
- SOP approval workflow
- Case triage war‑room
- Inspection role‑play (Inspector vs Company)