Pharmacovigilance
Pharmacovigilance process and system support
A reliable pharmacovigilance system depends on processes that people understand and follow. We help design and set up PV systems, improve existing ones, train staff and partners, and prepare for audits and inspections.
- Areas Workflows, literature monitoring, intake channels, training, audits
- Typical inputs Products, markets, organisation, current processes
- You receive Working processes, training and audit-ready records
Overview
About PV Process & System Support
Common weaknesses in PV systems are not technical — they are unclear responsibilities, missed information from sales or medical-information channels, inconsistent literature searches and training that does not reach the people who first hear about adverse events.
We map how safety information flows through your organisation and partners, close the gaps and set up the controls and training that keep the system working.
Use cases
When this service helps
Building a new PV system
Design processes before the first approval.
Improving an existing system
Fix gaps found in audits or inspections.
Training staff and partners
Ensure everyone knows how to recognise and pass on adverse events.
Pre-inspection checks
Audit the system ahead of an inspection.
Scope
What the service covers
- Process mapping of safety-information flows
- Adverse event intake through medical information and other channels
- Literature monitoring strategy (local and global)
- Training programmes, including initial and refresher training
- PV audits and inspection readiness
- Safety database selection support and process configuration
- Key performance indicators and oversight
Who does what
Safety database software, validation and hosting are provided by system vendors. Globaxa supports process design, configuration requirements and user training.
Why does literature monitoring matter?
Published case reports are a regulatory source of adverse events. Authorities expect systematic, documented searches of relevant literature — including local journals in markets where the product is sold.
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.
- MapHow safety information enters, moves and leaves the system.
- DesignProcesses, responsibilities and controls.
- ImplementProcedures, tools and training are rolled out.
- VerifyAudits and metrics confirm the system works.
Deliverables
What you receive
Process design
Process maps, responsibilities and controls.
Training
Material and records for staff and partners.
Audit report
Findings and recommendations for the PV system.
Technical basis
Guidelines we work to
- EU GVP Module I and IVPharmacovigilance systems, quality systems and PV audits.
- ICH E2D(R1)Post-approval safety data management.
- India: PvPI guidanceNational expectations for pharmacovigilance systems of MAHs.
What we need from you
- Product list and markets
- Organisation chart and current PV responsibilities
- Existing procedures and training records
- Previous audit or inspection findings
Please share confidential information only after an NDA is in place — we are happy to sign one first.
Market and jurisdiction considerations
PV system expectations are converging internationally around ICH and WHO principles, but local responsible-person, reporting and documentation rules still differ. We design systems that meet the requirements of each market where your products are authorised.
FAQs
PV Process & System Support: frequently asked questions
Can you train our sales and distribution partners?
Yes. Adverse event awareness training for staff and partners who may receive safety information is an important part of the system.
Do you carry out PV audits?
Yes, for your own system or for partners and service providers.
Do you set up medical information call centres?
We help design intake processes for medical information channels so adverse events are captured; call-centre staffing is arranged separately.
Talk to us about PV Process & System Support
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