Healthcare and life sciences / Managed BPO
Pharmacovigilance case processing and ICSR intake support
Actigy BPO prepares individual case safety report (ICSR) records from incoming safety information. We preserve the original source and receipt time, enter the reported event and flag missing information. Your safety function makes medical assessments and decides whether and when to submit.
Agree the scope, access and reviewer before a paid pilot.
- Original information
- Retain awareness date and source
- Later information
- Capture a separate follow-up receipt time
- Discrepancy
- Different event date remains visible
- Decision
- Safety reviewer chooses follow-up or new case
A worked example of the record and decision flow. Not a client case or promised result.
The work. The handoff. Your decision.
A defined workflow in your systems
For sponsors, marketing authorization holders and safety service providers with a safety database, approved operating procedures and a named medical or safety reviewer.
You provide
Incoming source narrative, original awareness and receipt times.
Actigy BPO prepares
Structured ICSR preparation, source links and missing-information worklist.
You retain
Medical assessment, reportability and submission timing.
Decision owner: Designated safety reviewer. Confirm this role and the escalation contact in the written scope.
Service detail / 01
What arrives in the safety reviewer’s worklist?
Define your intake channels, products, territories, urgency rules and escalation contacts first. The preparer captures source information, separates reported facts from gaps and provides a traceable file for review.
- Log source, receipt timestamp and original wording. Follow your procedure to record information available about the patient, reporter, suspected product and event.
- Search for potential duplicates and existing cases. Record the references and unresolved differences for the authorized reviewer to assess.
- Prepare the draft narrative, field entries and follow-up questions under your conventions. Flag uncertainty and route urgent reports immediately through the agreed path.
Worked example
How is new information linked to an existing case?
A partner sends additional information with a familiar product and event, but a different event date. The preparer preserves the new receipt time and original wording, links the possible prior record and identifies the date discrepancy. The designated safety reviewer decides whether this is a follow-up or a separate case. Keep the original awareness date and later follow-up receipt distinct.
Service detail / 03
How does quality control work?
Agree which critical fields need an additional check. Compare entries to the source record, confirm that the narrative distinguishes reported details from unknowns, and check that open questions have an owner. Where controlled terminology is in scope, work against the dictionary version and conventions approved by the client. Record discrepancies for correction or safety review.
Service detail / 04
Which decisions stay with your safety function?
Your qualified team owns seriousness, causality, expectedness, reportability, applicable deadlines and regulatory submission. The intake team follows your escalation timetable and routes incomplete or potentially urgent information promptly. Waiting for a complete file cannot replace escalation under your procedure.
Service detail / 05
How should a pilot be assessed?
Choose one product and source channel, with a mix of initial and follow-up reports. Define training, access permissions, review turnaround and the urgent backup contact. Reconcile the intake log against the safety system so every item has a case reference or documented follow-up owner. Measure handoff time and material QC corrections separately from cases awaiting your medical reviewer.
Before the first live queue
Bring the inputs that shape your scope
The proposal should identify what can be assigned, who can decide, and how you will accept the work. Start with one representative queue; agree any expansion after reviewing the pilot.
Define the workload
Intake channels, product scope and client case-processing procedure.
Agree the controls
Safety database permissions, terminology and escalation contacts.
Review the right measures
Intake-to-case reconciliation, data-entry errors and unresolved follow-ups.
Before you decide
Buyer questions
Clarify the work, access and approval boundaries before assigning a team.
Which parts of an ICSR queue can our safety team outsource?
Actigy BPO can prepare intake records, identify missing fields, reconcile follow-up information and return cases for quality review under your procedures. Your safety function makes medical judgments and retains responsibility for submission.
Can we outsource only intake or follow-up tracking?
Yes. Scope intake logging, preliminary data entry, draft narratives, QC or follow-up tracking as separate tasks. Your team identifies the systems and roles authorized to send follow-up requests and release a case.
Can Actigy work in our existing safety database?
Describe the platform, required training, role permissions and source-document restrictions. Review access and a deidentified sample through the approved channel before assigning any live records.
What determines case processing capacity?
Language, report source, initial versus follow-up mix, completeness, medical review handoffs and coverage hours all affect effort. A paid sample can establish how much preparation and QC each case type requires.
Discuss an ICSR intake queue
Share approximate initial and follow-up case volumes, source channels, languages, safety system and responsibility for medical review. Do not send patient or safety reports.
Your inquiry
Pharmacovigilance case processing
Describe the workload and the decision owner. Keep confidential records out of the form; agree a suitable channel for any later sample.
- Review the fitWe review the workflow and the inputs you provide.
- Define the scopeDiscuss access, coverage, review and the proposed fee.
- Agree a paid pilotApprove the written scope before work begins.