Pharmacovigliance System.
Advancing Patient Safety with Data-Driven Decisions
-
Pharmacovigilance is the monitoring of the safety of medicines. Pharmacovigilance is the science and activities associated with detecting, assessing, understanding, and preventing adverse effects or any other medicine-related problem.
-
It is essential because it helps to identify and understand the risks associated with medicines. It also helps to ensure that medicines are used safely and effectively.
Aggregate Report Management.
-
PSURs, PBRERs, PADERs, DSURs, ACOs, ASRs — routine and ad hoc
-
50+ reports delivered — zero deadline breaches
-
First-time-right benefit-risk narratives and line listing management
-
Structured templates for rapid turnaround under regulatory pressure
-
Regulatory-ready for FDA, EMA, MHRA, Health Canada, and DCGI
Signal Detection & Management.
-
Quantitative signal detection: PRR, ROR, EBGM disproportionality
-
Qualitative review across spontaneous databases and literature
-
Structured workflow: Detection → Validation → Prioritisation → Assessment → Action
-
Periodic Signal Detection Reports (PSDRs) aligned with GVP Module IX
-
Signal tracking, clinical assessment, and regulatory communication
Risk Management Plans (RMP / REMS).
-
EU Risk Management Plan strategy, authoring, and regulatory submission
-
US REMS design, implementation, and FDA correspondence
-
50+ RMPs delivered across oncology, rare disease, biologics, and generics
-
Safety information reviews, medical assessments, and full safety profiles
-
Risk minimisation measures and benefit-risk evaluation — lifecycle updates
Literature Monitoring.
-
Systematic screening across EMBASE, MEDLINE, PubMed, and other scientific literature databases — including local literature as required by regional regulatory obligations
-
Validated, reproducible search strategies with documented methodology
-
Structured workflow: Search → Screen → Triage → Report → Archive
-
Relevance filtering, deduplication, and AE case identification through manual review
-
Signal triage and escalation to the PV team for regulatory follow-up
Social Media Monitoring.
-
Ongoing monitoring of patient forums, social networks, and digital health platforms
-
Adverse event identification, triage, and case intake from digital sources
-
Platform-specific monitoring protocols aligned with GVP Module VI
-
Deduplication against spontaneous database records
-
Regulatory-compliant workflows for AE reporting from social sources
Medical Information Call Center (MICC).
-
Standard Response Document (SRD) development and version-controlled maintenance
-
On-label and off-label HCP and patient inquiry management
-
Multi-channel MICC operations — phone, email, and web
-
AE/SAE identification, escalation, and handover to drug safety team
-
Regulatory-compliant documentation, case logging, and reporting
ICSR Processing & Submission.
-
End-to-end ICSR management services covering the complete safety case lifecycle
-
Flexible need-based / ad hoc ICSR support tailored to client requirements
-
Strong focus on regulatory compliance, data integrity, and patient safety across the product lifecycle
-
Expertise aligned with global regulatory requirements, including:
-
European Medicines Agency (EMA)
-
Food and Drug Administration (FDA)
-
Medicines and Healthcare products Regulatory Agency (MHRA)
-
Other global health authorities
-
High-quality case processing with emphasis on accuracy, consistency & timely delivery
-
Comprehensive case lifecycle management, including:
-
Case intake and triage
-
Data entry
-
Medical coding & Quality control
-
Medical review & Regulatory submission
-
Delivery model built on:
-
Strong medical expertise
-
Robust quality management systems
-
Technology-enabled workflows
-
Proven capability in handling high-volume global case processing environments
-
Ensures seamless execution under stringent SLAs
Need more details? Contact us
We are here to assist. Contact us by phone, email or via our social media channels.
Call us: +91-8950072720
Mail us: pharmacovigilance.in@gmail.com