Pharmacovigilance & Drug Safety Outsourcing Services
Inovera is expanding into operational pharmacovigilance support for pharmaceutical companies, biotechnology organisations and contract research organisations (CROs) — delivering case processing and drug safety activities within your agreed systems, SOPs and procedures.
- UK-registered company (Scotland)
- Works within your systems & SOPs
- Dedicated, task or project-based
Delivered within your safety database
Using client-authorised systems, subject to agreed access and training.
This division is being established. Arrangements below describe our proposed approach — specific controls are agreed and evidenced with each client during supplier qualification.
Operational pharmacovigilance support
The services we are preparing to offer — core case processing and drug safety activities, performed to your conventions and quality standards once contracts, qualification and training are in place.
ICSR Processing
ICSR processing support under client-approved procedures and agreed responsibilities.
Adverse Event Data Entry
Accurate, structured entry of adverse event information into your authorised safety database, in line with your data entry guidelines.
Case Narrative Writing
Clear, chronological case narratives prepared to your templates and style conventions, ready for medical review.
Medical Coding Support
Coding of events, indications and medical history using your licensed dictionaries (e.g. MedDRA) and coding conventions.
Case Quality Control
Case quality checks against client-approved procedures and checklists.
Literature Monitoring
Screening of scientific and medical literature for potential safety information, following your search strategy and procedures.
Pharmacovigilance Documentation
Support with case-related documentation, trackers, reconciliation logs and filing in line with your document management requirements.
Dedicated Drug Safety Operational Support
A dedicated resource working as an extension of your safety team, under your SOPs, priorities and supervision.
A quality-first approach to drug safety support
We are clear about what is planned and what is agreed with each client. Evidence of the controls in place is provided during supplier qualification — not assumed.
Planned arrangement — being established by Inovera ahead of engagements. Agreed per client — defined through each client’s contract, SOPs and qualification.
Quality Management & GVP Awareness
A planned quality management approach, with training and GVP competency appropriate to assigned activities, and working practices aligned to the Good Pharmacovigilance Practices (GVP) modules relevant to the agreed services.
MHRA & Applicable Regulatory Requirements
Work is performed to support each client’s obligations under MHRA and other applicable regulations. Regulatory responsibility remains with the client (e.g. the marketing authorisation holder).
Standard Operating Procedures (SOPs)
Services are delivered under the client’s SOPs and work instructions. Inovera’s supporting internal procedures are being developed and will be shared during qualification.
Quality Control & Case Accuracy
Planned QC checkpoints, case quality checks against client-approved procedures and checklists, and client-agreed quality metrics, with findings tracked and fed back into training.
Training & Competency
Documented training records and client-specific training completed before any access to client systems or case data is granted.
Confidentiality & UK GDPR
Confidentiality agreements and data processing terms in place before work begins, with personal data handled only on documented client instructions in line with UK GDPR.
Information Security
Access through client-authorised accounts only, least-privilege principles and no storage of case data outside client-approved systems.
Client Audits & Supplier Qualification
Support for supplier qualification questionnaires, due-diligence requests and client audits, as agreed in the contract.
Business Continuity
Business continuity arrangements to be documented and shared with clients during supplier qualification.
Inovera Limited does not claim any pharmacovigilance-specific certifications or accreditations on this page. Responsibility for the pharmacovigilance system, regulatory reporting and medical assessment remains with the client unless otherwise agreed in writing.
A structured path from first conversation to delivery
Each engagement follows a controlled onboarding process, so services start only once contracts, qualification, access and training are in place.
- 1
Client Requirements
We understand your products, case volumes, services required and the systems and procedures in use.
- 2
Contract Agreement
Scope, responsibilities, timelines, confidentiality and data protection terms are agreed in writing.
- 3
Supplier Qualification
You complete your supplier qualification process; we provide the information and evidence you require.
- 4
Client Database Access & Training
Access to your client-authorised safety database is set up, and client-specific training is completed.
- 5
Service Delivery
Agreed activities are delivered within your systems, under your SOPs and to agreed timelines.
- 6
Quality Review
Ongoing quality review against agreed metrics, with regular reporting and continuous improvement.
Client-authorised safety database arrangements
Service delivery can take place within client-authorised safety databases, subject to agreed access and training. Inovera does not operate its own safety database — case data stays within the systems you control and approve.
Supplier details for your qualification process
Key company information for procurement, vendor onboarding and supplier qualification teams.
Contracting options
Dedicated
A dedicated resource allocated to your safety team on an agreed ongoing basis.
Task-based
Defined activities — such as case processing or QC — delivered as and when required.
Project-based
Time-bound support for backlogs, reconciliations or specific safety projects.
Company Profile
- Legal name
- INOVERA LIMITED
- Company number
- SC874398
- Registered office
- Ferry Road Avenue, Edinburgh
- Registration
- UK-registered company, Scotland
- Division
- Pharmacovigilance & Drug Safety Services
- Business enquiries
- support@inovera.co.uk
Supplier qualification & due diligence
Supplier questionnaires, confidentiality agreements and due-diligence requests can be raised through the business enquiry form below. We will respond with the information available and agree next steps with your quality team.
Discuss your pharmacovigilance requirements
Tell us about the support you need. We’ll respond within one business day.
Business enquiries only
Do not submit patient information or adverse event reports through this form. To report a suspected side effect in the UK, use the MHRA Yellow Card scheme or contact the medicine’s manufacturer.
support@inovera.co.uk
Supplier
INOVERA LIMITED · Company No. SC874398
Response time
Within one business day