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6 months · Offline / Online

PG Diploma in Pharmacovigilance & Regulatory Affairs (PGDPV) in Pune

6-month PG Diploma in Pharmacovigilance & Regulatory Affairs (PGDPV) in Pune at iLearn CRI: drug safety, ICSR processing, Argus, ARISg, Veeva Vault Safety & ABcube, signal detection, plus CDSCO, USFDA/EMA submissions, eCTD, and dossier compilation. ₹65,000 + GST (EMI available). Offline & online batches with direct placement support.

Duration
6 months
Mode
Offline / Online
Fees
₹65K

Two of pharma’s most in-demand careers in one diploma

If you are a B.Pharm, M.Pharm, or life-sciences graduate who wants a serious, job-ready entry into the pharmaceutical industry in 2026, the PG Diploma in Pharmacovigilance & Regulatory Affairs (PGDPV) gives you two of the most reliable career doors at once — drug safety and regulatory affairs — in a single structured 6-month programme.

The logic is structural. Every drug sold anywhere must be monitored for safety throughout its lifecycle, and every drug must be approved and kept compliant by regulators for that entire commercial life. Pharmacovigilance has the fastest hiring cycles in clinical research, and regulatory affairs offers one of the steadiest long-term compensation curves in pharma. Learning both — rather than one in isolation — makes you measurably more employable, because in practice the two disciplines are the same conversation: safety data drives label changes, risk management plans feed submissions, and PSURs are filed to authorities on regulatory timelines.

Pune is the right place to do this. The Hinjewadi-Wakad-Bhosari corridor houses PV and regulatory operations for pharma sponsors Cipla, Sun Pharma, Lupin, Glenmark, and Emcure, alongside CROs including Syngene, Veeda Clinical Research, Lambda Therapeutic Research, IQVIA, ICON, and Parexel — and all of them hire trained drug-safety and regulatory talent continuously.

What you will learn

The course is built around what employers actually test in interviews and expect on day one, not academic theory.

Pharmacovigilance operations. You build a working command of the ICSR lifecycle — intake, triage, MedDRA coding, narrative writing, causality assessment, and E2B(R3) electronic submission within 7- and 15-day timelines — the core of every entry-level drug-safety role.

Safety databases and analytics. You get hands-on with four safety platforms — Oracle Argus, ARISg and ABcube, plus an overview of Veeva Vault Safety — and progress into signal detection, aggregate reporting (PSUR, PBRER, DSUR), risk management plans, and GVP.

The regulatory framework. You gain real depth in CDSCO and the New Drugs and Clinical Trials Rules 2019, plus USFDA (21 CFR, IND/NDA/ANDA/BLA) and EMA procedures, so you can speak confidently about how drugs are approved and governed across markets.

Submissions and lifecycle compliance. You learn CTD/eCTD structure, sequence numbering and validation, DMF and dossier compilation, labelling, and post-marketing compliance — including the PV–regulatory interface where the two disciplines meet.

How the course is structured

PGDPV runs over six months in both offline (classroom) and online batches, so you can attend in person at our Wakad campus or join live from anywhere in India. Weekday-evening and weekend batches are available for working professionals.

The first phase builds pharmacovigilance foundations — terminology, the ICSR lifecycle, and MedDRA coding — followed by extended hands-on processing in Argus, ARISg and ABcube and progression into signal detection and aggregate reporting. The middle phase moves into the regulatory framework: CDSCO, USFDA, and EMA, then CTD/eCTD dossier compilation and DMF work. The final phase covers labelling, post-marketing compliance, inspection readiness, and intensive placement preparation. Faculty are practising PV and regulatory professionals from Pune’s pharma corridor — not full-time academics — so you learn from people who close cases and file submissions every day.

Placement infrastructure

We treat placement as a deliverable, not an afterthought. Every student completes structured placement preparation: PV- and regulatory-specific resume calibration, multiple rounds of mock interviews with hiring managers from partner companies, and direct introductions to our 50+ CRO and pharma partners across Pune. Because the diploma qualifies you for both drug-safety and regulatory roles, you apply into two hiring pipelines rather than one. Starting CTCs typically range from ₹3.6 to ₹4.8 LPA depending on the role and your degree, with clear progression to senior PV, signal management, and regulatory roles — and ₹16–28 LPA at manager level.

Who this course is right for

You will get the most out of PGDPV if you are:

  • A fresh graduate (B.Pharm, M.Pharm preferred; B.Sc, M.Sc in life sciences, microbiology, biotechnology, chemistry; BDS, BAMS, BHMS) who wants a job-ready entry into pharma
  • A working professional in an adjacent field who wants to add both drug-safety and regulatory skills to your profile
  • Someone who wants two entry doors, not one — the flexibility to start in PV and move into regulatory affairs, or vice versa
  • A career-switcher from healthcare or life sciences seeking a process-driven, office-based pharma role with strong progression

Apply for the next batch

Batches start every quarter at our Wakad, Pune campus, with limited seats per batch to protect hands-on platform access and faculty attention. Early applicants get priority for placement preparation and corporate partner introductions. EMI options are available across the programme.

Reach out via WhatsApp for an immediate conversation about your background and the right intake batch for you.

If you want a shorter entry point or an adjacent specialisation, the natural next steps are:

Further reading

Online & classroom

Available online and in the classroom

The PG Diploma in PV & RA course runs as two separate batches — a live online batch and an offline classroom batch at our Wakad campus — so you can train from anywhere in India or attend in person in Pune. Both run weekday evenings and full Saturdays, and both are fully instructor-led by practicing professionals.

Live online batch

Fully instructor-led live sessions with independent remote hands-on access to the same platforms (Argus, Medidata Rave, eCTD tools) and the same placement support — so you build a real portfolio from home. Designed for students across India and working professionals who can't relocate to Pune.

Classroom batch (Pune)

In-person at our Wakad campus in the Hinjewadi-Wakad corridor, with hands-on lab access and face-to-face faculty time — ideal for Pune-based students who want maximum platform practice.

Not sure which batch suits you? Talk to admissions about the current schedule, or see all online clinical research courses.

Curriculum

What you’ll learn, module by module.

  1. 01 Pharmacology & Drug Development
    • Basics of pharmacology, pharmacodynamics and pharmacokinetics
    • Routes of administration and dosage forms
    • The drug development pipeline
  2. 02 The Clinical Research Industry & Trial Phases
    • Structure of the industry; sponsor and CRO roles
    • Phases of clinical trials
    • Where safety obligations attach at each stage
  3. 03 Introduction to Pharmacovigilance & Drug Safety
    • History and evolution of drug safety surveillance
    • The WHO-UMC framework and key terminology
    • Stakeholders across the safety ecosystem
  4. 04 Pharmacoepidemiology & Biostatistics for Drug Safety
    • Epidemiological and statistical principles used in PV practice and research
    • Study designs
    • Measures of association and their interpretation
  5. 05 Adverse Drug Reactions & Safety Reports
    • AE versus ADR and classification of ADRs
    • SAE reporting
    • Side effects and medication errors
  6. 06 Seriousness, Expectedness & Causality Assessment
    • Expectedness assessment
    • Causality methods
    • The Naranjo algorithm and Hill's criteria applied to worked cases
  7. 07 ICSR Processing & Case Management
    • Full ICSR lifecycle: intake, triage and prioritisation
    • Data entry and narrative writing
    • Quality review and reconciliation
    • E2B(R3) submission
  8. 08 Drug Dictionaries & Coding
    • MedDRA hierarchy and coding conventions
    • WHO Drug Dictionary and MedWatch
    • Version migration scenarios with practical exercises
  9. 09 Argus Safety — Extended Hands-on
    • Interface walkthrough and case entry
    • Workflow management and case assignment
    • Querying
    • User roles and access management
  10. 10 ARISg, Veeva Vault Safety & ABcube
    • Case processing across mid-market and modern platforms
    • Comparative analysis of the four systems
    • Database migration projects
  11. 11 Clinical Trial Safety, SAE & SUSAR Reporting
    • Safety reporting inside clinical trials
    • SAE and SUSAR management
    • Blinding and unblinding
    • Expedited reporting timelines
  12. 12 Aggregate Safety Reports
    • DSUR, PADER, PBRER and PSUR
    • Data sources, structure and authoring conventions
    • Review cycles and submission obligations
  13. 13 Literature Surveillance & Case Retrieval
    • Systematic literature search strategies
    • Screening and duplicate detection
    • Local literature obligations
    • Documentation standards
  14. 14 Signal Detection & Data Mining
    • Data sources and tools
    • Disproportionality analysis (PRR, ROR, EBGM)
    • Data-mining methodologies
    • Signal validation workflows
  15. 15 Risk Management Plans & Risk Minimisation
    • RMP structure and safety specifications
    • Pharmacovigilance plans
    • Additional risk minimisation measures
    • Effectiveness evaluation
  16. 16 AI & Automation in Pharmacovigilance
    • Machine learning for intake and triage
    • NLP literature screening and duplicate detection
    • AI-assisted coding and narrative drafting
    • Validation and GxP expectations governing AI in a regulated safety system
  17. 17 Global Regulatory Framework & Agencies
    • CDSCO India, USFDA, EMA Europe, MHRA UK and TGA Australia
    • Obligations and timelines
    • Medicines risk communication
  18. 18 Regulatory Submissions — CTD, eCTD & Dossiers
    • CTD and eCTD architecture
    • Module-by-module dossier compilation
    • Submission pathways
    • Publishing conventions
  19. 19 Labelling, Safety Communication & Lifecycle Maintenance
    • Company core data sheets
    • SmPC, USPI and patient information
    • Safety label changes
    • Variations and post-approval commitments
  20. 20 AI in Regulatory Affairs & Regulatory Intelligence
    • AI-assisted dossier authoring and document management
    • Automated regulatory intelligence and change monitoring
    • Structured product data and IDMP
    • Evolving agency positions on AI
  21. 21 PvPI, Materiovigilance & Herbal Pharmacovigilance
    • Indian Pharmacopoeia Commission services and ADR reporting in India
    • The Materiovigilance Programme
    • Device vigilance abroad
    • PV of herbal medicines
  22. 22 GVP, Audits & Regulatory Inspections
    • Good Pharmacovigilance Practices
    • PV System Master File
    • Inspection coordination and readiness
    • Common audit findings
  23. 23 Quality Management, SDEA & PV Project Management
    • Deviations and CAPA
    • Safety data exchange agreements and vendor oversight
    • Metrics and compliance tracking
    • PV project management
  24. 24 Industry Case Studies, Capstone & Internship
    • Real anonymised scenarios from partner CROs
    • Assessed capstone project
    • Supervised internship block
    • Bonus: PV and RA specific resume, LinkedIn optimisation and mock interviews simulating pharma and CRO hiring rounds
Career outcomes

Roles graduates step into.

  • Drug Safety Associate
    Avg. CTC ₹ 3.6–4.5 LPA
  • Pharmacovigilance Scientist
    Avg. CTC ₹ 5.0–7.0 LPA
  • Regulatory Affairs Associate
    Avg. CTC ₹ 3.6–4.8 LPA
  • Regulatory Affairs Executive
    Avg. CTC ₹ 5.0–7.0 LPA
  • Senior PV / Signal Management (3-5 yrs)
    Avg. CTC ₹ 8.0–12.0 LPA
  • Regulatory Affairs Manager (7+ yrs)
    Avg. CTC ₹ 16.0–28.0 LPA
Placements

Where clinical research careers start in Pune.

Our placement record reflects what most clinical research institutes in Pune don’t measure: not just where you start, but how fast you grow inside pharma and CROs.

Alumni Working Across Pharma
50+

Alumni Working Across Pharma & CRO Industry

Average Industry Starting CTC
₹4.2L

Average Industry Starting CTC

Placement Assistance Support
100%

Placement Assistance Support

Pharma & CRO Hiring
50+

Pharma & CRO Hiring Partners

FAQ

Questions about the PG Diploma in PV & RA

Can’t find your answer? Reach out on WhatsApp—we usually reply within an hour during business days.

Ask on WhatsApp →
What is the fee for the PG Diploma in Pharmacovigilance & Regulatory Affairs in Pune?

The 6-month PG Diploma in Pharmacovigilance & Regulatory Affairs (PGDPV) at iLearn CRI in Pune is ₹65,000 + 18% GST. The fee covers all course materials, Argus, ARISg and ABcube lab access, MedDRA coding practice, hands-on CTD/eCTD dossier compilation, and structured placement preparation. EMI options are available, and most students opt for a multi-installment plan spread across the programme.

Is the PG Diploma in Pharmacovigilance & Regulatory Affairs available online?

Yes. The PG Diploma runs in both offline (classroom) and online batches, so you can attend in person at our Wakad, Pune campus or join live from anywhere in India. Both modes follow the same curriculum, the same faculty, and the same placement support. Many working professionals choose the online or hybrid batch so they can upskill without leaving their current job, while the hands-on Argus, ARISg, and eCTD sessions are supported in both formats.

Why combine pharmacovigilance and regulatory affairs in one diploma?

In real pharma operations the two disciplines are deeply connected — safety data drives label changes, RMPs feed regulatory submissions, and PSURs are filed to authorities on regulatory timelines. Graduates who understand both are far more employable and mobile: they can start in drug safety, move laterally into regulatory affairs, and grow into roles that own the PV–regulatory interface. Combining both in one 6-month diploma gives you two entry doors into pharma instead of one, and a clearer long-term progression than a single-subject course.

What is the difference between the 3-month Certificate and this 6-month PG Diploma?

The Certificate in Pharmacovigilance & Regulatory Affairs is a focused, affordable entry credential that introduces drug safety and the regulatory framework. The PG Diploma (PGDPV) is a broader, deeper 6-month programme with far more hands-on work — extended Argus, ARISg and ABcube processing, signal detection, aggregate reporting, and full CTD/eCTD dossier compilation — plus deeper coverage of CDSCO, USFDA, and EMA. If you want a quick foundation, start with the Certificate; if you want to be job-ready across both PV and regulatory roles with genuine tool depth, the PG Diploma is the stronger investment.

Is this course worth it after B.Pharm?

Pharmacovigilance has the fastest hiring cycles in clinical research, and regulatory affairs is one of the most stable, well-paid pharma paths. For B.Pharm and M.Pharm graduates, combining both is one of the highest-return options available in 2026. Pune houses PV and regulatory operations of Cipla, Sun Pharma, Lupin, Glenmark, and Emcure, plus CROs like Syngene, Veeda, Lambda, IQVIA, ICON, and Parexel — all of which hire trained PV and regulatory talent continuously, with entry CTCs from ₹3.6 LPA and rapid progression.

Do you provide placement support after the PG Diploma?

Yes. Every student receives structured placement assistance: PV- and regulatory-specific resume calibration, multiple rounds of mock interviews with practising professionals, and direct introductions to our 50+ pharma and CRO partners across Pune. Final placement depends on individual performance, but the support infrastructure is comprehensive and identical to our other diploma programmes.

What tools and software will I get hands-on with?

On the pharmacovigilance side you get hands-on exposure to four safety platforms — Oracle Argus Safety, ARISg and ABcube for case processing, plus a Veeva Vault Safety overview — and MedDRA coding practice. On the regulatory side you compile sections of a sample CTD/eCTD dossier, work through sequence numbering and validation, and get an introductory walkthrough of industry eCTD tools. This dual-tool exposure is exactly what Pune employers screen for in both PV and regulatory interviews.