Drug Safety · Pharmacovigilance · India
End-to-End Pharmacovigilance Services, From First Patient to Post-Marketing
Shen Clinical Services runs pharmacovigilance and drug safety for clinical trials and marketed products. We process adverse event cases, write PSURs and DSURs, detect and evaluate signals, and set up the Pharmacovigilance Officer In-charge role and system master file India requires, all to CDSCO, PvPI and ICH E2 standards.
ICH E2A to E2FGlobal safety guidelines
CDSCO and PvPIIndian reporting rules
PvOI and PSMFYour India PV system
FSP ModelEmbedded safety teams
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Across the Lifecycle
Pharmacovigilance Services Across the Product Lifecycle
One safety team covers your product from the first trial participant to years after approval, so clinical safety services and post-marketing pharmacovigilance share the same data and people:
| Activity | What we do | Guideline |
|---|---|---|
| Clinical trial safety | SAE and SUSAR processing, safety narratives, SAE reconciliation, DSURs | ICH E2A, E2F; NDCT Rules, 2019 |
| Case processing | ICSR intake, triage, MedDRA coding, causality assessment and electronic submission | ICH E2B(R3); MedDRA |
| Aggregate reports | PSURs and PBRERs for marketed products, DSURs for products in development | ICH E2C(R2), E2F |
| Signal management | Signal detection, validation, evaluation and follow-up actions | ICH E2E |
| Risk management | Risk management plans and risk minimisation measures | ICH E2E |
| Literature monitoring | Global and Indian literature screening for safety information | ICH E2D |
| PV system and compliance | PvOI, PSMF, SOPs, training, audits and inspection readiness | Schedule M; IPC guidance for MAHs |
India Requirements
Pharmacovigilance Requirements in India
These are the main pharmacovigilance obligations for companies selling or testing medicines in India:
| Requirement | Rule / timeline |
|---|---|
| Pharmacovigilance system | Mandatory for licensees (Schedule M, Drugs and Cosmetics Rules, 1945) and for new drug importers and manufacturers (NDCT Rules, 2019) |
| Pharmacovigilance Officer In-charge | Medical officer or pharmacist trained in ADR analysis, resident in India |
| Pharmacovigilance System Master File | Describes the PV system; maintained separately from the marketing authorisation dossier |
| Serious unexpected adverse events | Reported to CDSCO within 15 calendar days of first receipt |
| PSURs for new drugs | Every 6 months for 2 years, then annually for 2 years; due within 30 calendar days of period end |
| Clinical trial deaths | SAE reports within 14 days of knowledge (Rule 42, NDCT Rules, 2019) |
| National programme | Reports also feed the Pharmacovigilance Programme of India (PvPI), run by the Indian Pharmacopoeia Commission |
| Medical devices | Adverse events reported under the Materiovigilance Programme of India (MvPI) |
Technology
Technology-Enabled Drug Safety Operations
Every case and report runs through technology-enabled workflows built for speed, traceability and inspection readiness:
- AI-assisted case intake: automation speeds up data entry and duplicate checks, while trained safety professionals make every medical judgement
- Deadline tracking for every case: each ICSR, PSUR and DSUR is tracked against its regulatory clock, with alerts before it falls due
- Centralised submission tracking: one view of every submission to CDSCO, other regulators and ethics committees
- Stage-gate quality reviews: senior reviewers sign off each step before work moves on
- Full audit trail: every action recorded, so audits and inspections are straightforward
Our Process
How Our Pharmacovigilance Process Works
STEP 01
Set Up
We agree safety data exchange terms, write SOPs and configure the safety database for your products.
STEP 02
Collect and Process
We receive, triage, code and assess every case, and submit it within the regulatory deadline.
STEP 03
Analyse
We write aggregate reports, run signal detection and screen the literature for new safety information.
STEP 04
Govern
We keep the PSMF current, run audits and corrective actions, and keep you ready for CDSCO inspection.
Why Shen
Why Choose Shen Among Pharmacovigilance Service Providers in India
Physician-Led Medical Review
Clinicians assess causality, seriousness and signals, not just data processors.
India and Global Rules
CDSCO, PvPI and ICH requirements handled by one team, working alongside your EU or UK QPPV so Indian safety data flows into your global system.
FSP or Full Outsourcing
Use our team as your complete safety department, or scale up with dedicated safety specialists embedded in your processes, systems and SOPs.
Connected to Your Trials
Our clinical trial pharmacovigilance services sit alongside our clinical trial and clinical data management teams for clean reconciliation.
What We Cover
Our Drug Safety and Pharmacovigilance Services
ICSR case processing
SAE and SUSAR management
Safety narratives
PSURs and PBRERs
DSURs
Signal management
Risk management plans
Literature monitoring
PvOI set-up and support
PSMF preparation
PV audits and inspection readiness
Safety committee management
FAQs
Pharmacovigilance Services: Frequently Asked Questions
What do pharmacovigilance services include?
Pharmacovigilance services cover the collection, processing and reporting of adverse events, periodic safety reports such as PSURs and DSURs, signal detection, risk management plans, literature monitoring and the systems, people and audits that keep a company compliant. Shen can run all of these or support your in-house team.
Is a pharmacovigilance system mandatory in India?
Yes. Schedule M of the Drugs and Cosmetics Rules, 1945 requires licensees to have a pharmacovigilance system, and under the New Drugs and Clinical Trials Rules, 2019 anyone importing or manufacturing a new drug for sale must have one. The system must be run by qualified, trained personnel.
What is a Pharmacovigilance Officer In-charge (PvOI)?
The PvOI is the person responsible for a company’s pharmacovigilance system in India. Under the Indian Pharmacopoeia Commission’s guidance for marketing authorisation holders, the PvOI should be a medical officer or pharmacist trained in analysing adverse drug reaction reports and must reside in India. Shen helps you define the role, appoint and train your PvOI, and runs the pharmacovigilance system behind them.
How often are PSURs required in India?
For a new drug, PSURs are due every six months for the first two years after approval and annually for the following two years, unless CDSCO extends the period. Each PSUR must be submitted within 30 calendar days of the end of the reporting period.
What are the timelines for reporting serious adverse events in India?
Serious unexpected adverse events for marketed products must be reported to CDSCO within 15 calendar days of first receiving the information. In clinical trials, serious adverse events involving death must be reported within 14 days of knowledge under Rule 42 of the NDCT Rules, 2019.
Can Shen provide pharmacovigilance as an FSP model?
Yes. Alongside full outsourcing, we offer pharmacovigilance as a functional service provider (FSP) model, placing trained safety staff into your processes, systems and SOPs under your oversight.
Resource Spotlight
Need safety documents written? Our medical writing services prepare DSURs, PSURs and safety narratives. Selling devices or diagnostics? See our medical device and IVD registration services for materiovigilance support. Registering a vaccine or biologic? See our biologics registration services.
Keep Your Products Safe and Compliant
Launching in India? Ask about setting up your PV system, PvOI and PSMF.
Need extra capacity? Ask about our FSP pharmacovigilance model.
+91 98968 89927 · info@shenclinicalservices.com · A 302, Urban Square, Sector-62, Gurugram, Haryana 122098
Sources: IPC Pharmacovigilance Guidance Document for MAHs of Pharmaceutical Products, Version 2.0; CDSCO pharmacovigilance guidance for vaccines; ICH E2A to E2F; New Drugs and Clinical Trials Rules, 2019. General regulatory information, not legal advice.