Pharmacovigilance
Outsourced pharmacovigilance services
Pharmacovigilance is a continuous obligation, but few growing companies need a large in-house team. We provide flexible support — from single activities such as literature monitoring to a coordinated package of PV operations — while you keep oversight and responsibility.
- Activities ICSR processing, literature, aggregate reports, signals, PSMF, training
- Typical inputs Product list, markets, existing SOPs and agreements
- You receive Defined PV services with agreed timelines and reports
Overview
About Pharmacovigilance Services
The marketing authorisation holder remains responsible for its pharmacovigilance system even when activities are outsourced. Successful outsourcing therefore depends on clear agreements, defined timelines, good communication and oversight metrics.
We start by understanding your products, markets and current arrangements, then agree which activities we perform and how we report on them. The result is a PV service sized to your needs, with documented responsibilities.
Use cases
When this service helps
Small or new PV functions
Get started with compliant processes and support.
Peaks in workload
Additional capacity for case processing or periodic reports.
Multi-market portfolios
Coordinated activities across several countries.
Partner and licensing arrangements
Support for safety data exchange agreements.
Scope
What the service covers
- Individual case safety report (ICSR) processing
- Local and global literature monitoring
- Aggregate report preparation (PSUR/PBRER, PADER, DSUR, national reports)
- Signal detection support and evaluation
- PV documentation: PSMF, SOPs, safety data exchange agreements
- Training for staff and partners on adverse event reporting
- Support to your QPPV or local responsible person
Who does what
Regulatory responsibility for pharmacovigilance remains with the marketing authorisation holder. Globaxa performs the agreed activities and provides oversight reports.
What should a PV agreement include?
Activities and responsibilities, timelines for exchanging and reporting safety information, data formats, reconciliation, quality metrics, audit rights and how changes are managed.
Methodology
How we work
A defined sequence, agreed with you at the start, so you always know what happens next and what we need from you.
- ScopeProducts, markets and activities are defined.
- AgreeResponsibilities, timelines and metrics are written into an agreement.
- TransitionProcesses, access and training are set up.
- Operate and reportActivities are performed and reported against agreed metrics.
Deliverables
What you receive
PV services
The agreed activities, performed to defined timelines.
Oversight reports
Regular metrics on volumes, timeliness and quality.
Documentation
SOPs, agreements and records supporting inspection readiness.
Technical basis
Guidelines we work to
- ICH E2 seriesInternational standards for expedited reporting (E2A), ICSR transmission (E2B), periodic reports (E2C), post-approval safety data (E2D), PV planning (E2E) and DSURs (E2F).
- EU Good Pharmacovigilance Practices (GVP)Detailed modules on PV systems and processes in the EU.
- India: NDCT Rules, 2019 and PvPINational pharmacovigilance requirements and reporting to the Pharmacovigilance Programme of India.
What we need from you
- Product list and markets where products are authorised
- Existing PV SOPs, PSMF and agreements
- Sources of safety information (medical information, partners, literature)
- Current case volumes and reporting obligations
Please share confidential information only after an NDA is in place — we are happy to sign one first.
Market and jurisdiction considerations
PV requirements vary by country — local reporting forms, timelines, periodic report schedules and responsible-person rules. We map the obligations for each market where your products are authorised.
FAQs
Pharmacovigilance Services: frequently asked questions
Can we outsource only some activities?
Yes. Many clients start with literature monitoring or periodic reports and add services later.
How do we keep oversight?
Through the written agreement, regular metrics, reconciliations and periodic review meetings — all of which we provide.
Do you work with partners’ PV systems?
Yes. We can support safety data exchange with licensing partners and distributors.
Talk to us about Pharmacovigilance Services
Share your product, target market and timeline. We will review your requirement and propose a defined scope.
- OfficeFlat no 8-9-3/23/1, Subhash Chandra Bose Colony, Dathunagar, Kanchanbagh, Hyderabad, Telangana 500058, India
Open in Google Maps - Phone+91 81219 33381
+91 99894 74590 - Emailbd@globaxa.in
- Office hoursMonday to Friday, 10:00–19:00 IST