Service
Pharmacovigilance & Drug Safety
Safety case handling, surveillance and aggregate reporting support aligned to good practice.
Overview
Patient safety depends on timely, consistent handling of adverse event information. We provide structured, documented support for the day-to-day work of drug safety.
Our teams operate within the procedures and safety systems you specify, with clear escalation routes for medical judgement.
Standards & frameworks we work within
- ICH E2A–E2F safety guidelines
- EU GVP modules
- Pharmacovigilance Programme of India (PvPI) guidance
- FDA 21 CFR 312 / 314 safety reporting requirements
These are frameworks we work within or align to. They do not imply certification, accreditation or endorsement.
What we deliver
- Adverse event case intake and data entry support
- MedDRA and WHO Drug coding support
- Literature surveillance and screening
- Aggregate report drafting support (e.g. PSUR/PBRER, DSUR inputs)
- Safety reconciliation with clinical databases
- Signal detection support and tracking
Typical deliverables
- Processed case documentation
- Literature screening logs
- Aggregate report drafts
- Reconciliation reports
Engagement models
Project-based
A defined scope, timeline and set of deliverables agreed up front.
Dedicated capacity
Specialists embedded in your workflow on a longer-term, scalable basis.
Advisory & ad hoc
Targeted expert input, reviews or surge support when you need it.
Frequently asked questions
Service descriptions are general and informational. Scope, responsibilities and outputs are defined in a written agreement for each engagement.
Explore other services in the services overview.
Discuss pharmacovigilance & drug safety
Tell us about your programme. We’ll respond with an honest view of how we can help, and where we can’t.