SS BIO ACADEMY
Pharmacovigilance Certification
Full study syllabus, module allocations, eligibility, and scholarship enrollment rates.
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Duration: 3 Months
Syllabus Curriculum Breakdown
Master the science of monitoring drug safety, detecting adverse reactions, risk assessment, and understanding complex global regulatory codes.
Course Module of Pharmacovigilance
40 Hours Total- Module 1: Introduction to Pharmacovigilance (5 Hrs)
- Module 2: Adverse drug reactions (ADR) and reporting method (4 Hrs)
- Module 3: ICH Guidelines for Pharmacovigilance & aggregate reports (8 Hrs)
- Module 4: D&C Act and Schedule Y compliance (4 Hrs)
- Module 5: Coding with MedDRA and WHO drug coding dictionaries (4 Hrs)
- Module 6: Signal detection in PV & safety signal evaluations (4 Hrs)
- Module 7: Benefit – risk assessment in PV (4 Hrs)
- Module 8: Crisis management in drug safety (4 Hrs)
- Module 9: PV regulations in various countries (USFDA, EMA, CDSCO) (3 Hrs)
Authorized Eligibility Requirements
Pharmacy
MBBS
BDS
Nursing
B.Sc.
M.Sc.
Life Sciences graduates
Select Academic Plan
Standard Tier
Curriculum Open
- Structured curriculum with case assessments
- Digital manual on MedDRA coding basics
- Certificate of course completion
- Standard mock test series
Premium Placement Tier
Full Support
- All Standard Tier benefits
- Elite practical training with real-life safety case files
- Intensive hands-on MedDRA database tool trials
- 1-on-1 personalized profile tuning by PV Team Leads
- 100% Placement screening guarantee at top safety CROs
- Internship certificate from premium partner clinical center
Apply for Scholarship Slot
Get counseling directly from academic directors under scholarship parameters.