, home
Customer access Request an enterprise demo
Request an enterprise demo Customer access

Pharmaceuticals & biotechnology / APPLICATION BLUEPRINT

Drug Safety Case Intake & Follow-up

Coordinate suspected adverse-event intake, missing-information follow-up, qualified medical review and approved reporting records.

Start generatingExplore illustrative interface

12 workspace menus · 12 business workflows · 5 role profiles

Application blueprint only. This is a proposed design, not a deployed or production-tested system. Screens and sample figures are illustrative; workflows, business rules, approvals, permissions and integrations require confirmation before build.

Designed for Drug safety operations director

Drug Safety Case Intake & Follow-up workspace interface preview; illustrative records and figures.
Drug Safety Case Intake & Follow-up — operational workspaceIllustrative interface · Sample dataView full interface →

Explore an illustrative interface.

Illustrative workspace and record review. Select a concept screen to inspect it in full.

Drug Safety Case Intake & Follow-up workspace interface preview; illustrative records and figures.
Drug Safety Case Intake & Follow-up — operational workspaceIllustrative interface · Sample dataView full interface →
Drug Safety Case Intake & Follow-up record interface preview; illustrative records and figures.
Drug Safety Case Intake & Follow-up — record and workflow reviewIllustrative interface · Sample dataView full interface →

Operational dashboards and work queues.

Operational views

Review work, evidence, exceptions and authorised decisions within a defined operating scope.

Site / programmePeriodAssigned teamReview state

Dashboard measures

  • Active operational records
    Count of all records in the selected workspace.
  • Review queue
    Records at the third stage of the business workflow.
  • Needs attention
    Records with an assigned review requirement.
  • Final-stage records
    Records in the fourth business workflow stage.

Business workflow and operating scope

Coordinate suspected adverse-event intake, missing-information follow-up, qualified medical review and approved reporting records. A safety case can lose important context as source reports, follow-up requests and review decisions move between teams. The system connects intake to case closure with accountable review steps, preserving the source evidence and the approved reporting position for each case.

Operations

Operational overview

Review the work position and priority actions.

Safety report intake

Coordinate safety report intake with assigned responsibilities, linked records and review history.

Source evidence records

Coordinate source evidence records with assigned responsibilities, linked records and review history.

Follow-up requests

Coordinate follow-up requests with assigned responsibilities, linked records and review history.

Medical review routing

Coordinate medical review routing with assigned responsibilities, linked records and review history.

Coding records

Coordinate coding records with assigned responsibilities, linked records and review history.

Reporting task tracking

Coordinate reporting task tracking with assigned responsibilities, linked records and review history.

Case closure review

Coordinate case closure review with assigned responsibilities, linked records and review history.

Insights

Reports and saved views

Review the reporting scope and export agreed operational views.

Governance

Approvals and exceptions

Review delegated decisions, exceptions and recorded conditions.

Audit history

Trace accepted changes, decisions and accountable actions.

Access and configuration

Manage the agreed role permissions and configurable operating rules.

The end-to-end business journey.

From intake to authorised completion, with evidence at each decision.

01

Receive the report

Receive suspected adverse event report.

02

Complete source information

Collect missing source information.

03

Route qualified review

Route medical review and coding.

04

Track approved reporting

Track approved reporting and case closure.

Business workflows

Select a workflow to review the steps, responsibilities, approval and exception handling.

01 · Coordinate safety report intake

Coordinate safety report intake within Pharmacovigilance case intake and follow up.

Trigger
Safety report intake requires a new record, an agreed review or a controlled change.

Responsible role
Safety intake officer

  • Register safety report intake and its operating scope
  • Assign the accountable owner and required actions
  • Review the relevant evidence and unresolved conditions
  • Confirm the accepted outcome and retain its history

Approval
Reporting officer records the decision when the action changes an accepted commitment or requires delegated authority.

Exception handling
Required information or responsibility is missing, or an operating condition changes.

Outcome
A completed operating record with its linked evidence and remaining obligations.

02 · Coordinate source evidence records

Coordinate source evidence records within Pharmacovigilance case intake and follow up.

Trigger
Source evidence records requires a new record, an agreed review or a controlled change.

Responsible role
Qualified medical reviewer

  • Register source evidence records and its operating scope
  • Collect the linked records and qualified evidence
  • Assign the responsible reviewer and record findings
  • Accept the outcome or assign corrective follow-up

Approval
Reporting officer records the decision when the action changes an accepted commitment or requires delegated authority.

Exception handling
Evidence is incomplete, disputed, expired or outside the reviewer’s authority.

Outcome
A review finding, its accepted evidence and any accountable corrective actions.

03 · Coordinate follow-up requests

Coordinate follow-up requests within Pharmacovigilance case intake and follow up.

Trigger
Follow-up requests requires a new record, an agreed review or a controlled change.

Responsible role
Safety intake officer

  • Register follow-up requests and its operating scope
  • Assign the accountable owner and required actions
  • Review the relevant evidence and unresolved conditions
  • Confirm the accepted outcome and retain its history

Approval
Reporting officer records the decision when the action changes an accepted commitment or requires delegated authority.

Exception handling
Required information or responsibility is missing, or an operating condition changes.

Outcome
A completed operating record with its linked evidence and remaining obligations.

04 · Coordinate medical review routing

Coordinate medical review routing within Pharmacovigilance case intake and follow up.

Trigger
Medical review routing requires a new record, an agreed review or a controlled change.

Responsible role
Qualified medical reviewer

  • Register medical review routing and its operating scope
  • Collect the linked records and qualified evidence
  • Assign the responsible reviewer and record findings
  • Accept the outcome or assign corrective follow-up

Approval
Reporting officer records the decision when the action changes an accepted commitment or requires delegated authority.

Exception handling
Evidence is incomplete, disputed, expired or outside the reviewer’s authority.

Outcome
A review finding, its accepted evidence and any accountable corrective actions.

05 · Coordinate coding records

Coordinate coding records within Pharmacovigilance case intake and follow up.

Trigger
Coding records requires a new record, an agreed review or a controlled change.

Responsible role
Safety intake officer

  • Register coding records and its operating scope
  • Assign the accountable owner and required actions
  • Review the relevant evidence and unresolved conditions
  • Confirm the accepted outcome and retain its history

Approval
Reporting officer records the decision when the action changes an accepted commitment or requires delegated authority.

Exception handling
Required information or responsibility is missing, or an operating condition changes.

Outcome
A completed operating record with its linked evidence and remaining obligations.

06 · Coordinate reporting task tracking

Coordinate reporting task tracking within Pharmacovigilance case intake and follow up.

Trigger
Reporting task tracking requires a new record, an agreed review or a controlled change.

Responsible role
Safety intake officer

  • Register reporting task tracking and its operating scope
  • Assign the accountable owner and required actions
  • Review the relevant evidence and unresolved conditions
  • Confirm the accepted outcome and retain its history

Approval
Reporting officer records the decision when the action changes an accepted commitment or requires delegated authority.

Exception handling
Required information or responsibility is missing, or an operating condition changes.

Outcome
A completed operating record with its linked evidence and remaining obligations.

07 · Coordinate case closure review

Coordinate case closure review within Pharmacovigilance case intake and follow up.

Trigger
Case closure review requires a new record, an agreed review or a controlled change.

Responsible role
Qualified medical reviewer

  • Register case closure review and its operating scope
  • Collect the linked records and qualified evidence
  • Assign the responsible reviewer and record findings
  • Accept the outcome or assign corrective follow-up

Approval
Reporting officer records the decision when the action changes an accepted commitment or requires delegated authority.

Exception handling
Evidence is incomplete, disputed, expired or outside the reviewer’s authority.

Outcome
A review finding, its accepted evidence and any accountable corrective actions.

08 · Register the operating requirement

Coordinate operating requirement within Pharmacovigilance case intake and follow up.

Trigger
Operating requirement requires a new record, an agreed review or a controlled change.

Responsible role
Safety intake officer

  • Register operating requirement and its operating scope
  • Compare options, dependencies and operating constraints
  • Review the selected option with its accountable owners
  • Accept the plan and track its delivery conditions

Approval
Reporting officer records the decision when the action changes an accepted commitment or requires delegated authority.

Exception handling
An assumption changes, prerequisites are missing or stakeholders cannot accept the proposed commitment.

Outcome
An approved operating plan and owned actions for its accepted conditions.

09 · Resolve operating exceptions

Coordinate operating exceptions within Pharmacovigilance case intake and follow up.

Trigger
Operating exceptions requires a new record, an agreed review or a controlled change.

Responsible role
Safety intake officer

  • Register operating exceptions and its operating scope
  • Gather the relevant evidence and review options
  • Route the case to the delegated decision owner
  • Record the outcome, conditions and follow-up obligations

Approval
Reporting officer records the decision when the action changes an accepted commitment or requires delegated authority.

Exception handling
The case exceeds delegation, contains a conflict or has disputed evidence.

Outcome
An authorised decision or escalation with accountable resolution actions.

10 · Verify completion and follow-up

Coordinate completion and follow-up within Pharmacovigilance case intake and follow up.

Trigger
Completion and follow-up requires a new record, an agreed review or a controlled change.

Responsible role
Qualified medical reviewer

  • Register completion and follow-up and its operating scope
  • Collect the linked records and qualified evidence
  • Assign the responsible reviewer and record findings
  • Accept the outcome or assign corrective follow-up

Approval
Reporting officer records the decision when the action changes an accepted commitment or requires delegated authority.

Exception handling
Evidence is incomplete, disputed, expired or outside the reviewer’s authority.

Outcome
A review finding, its accepted evidence and any accountable corrective actions.

11 · Review controlled operating changes

Coordinate controlled operating changes within Pharmacovigilance case intake and follow up.

Trigger
Controlled operating changes requires a new record, an agreed review or a controlled change.

Responsible role
Qualified medical reviewer

  • Register controlled operating changes and its operating scope
  • Collect the linked records and qualified evidence
  • Assign the responsible reviewer and record findings
  • Accept the outcome or assign corrective follow-up

Approval
Reporting officer records the decision when the action changes an accepted commitment or requires delegated authority.

Exception handling
Evidence is incomplete, disputed, expired or outside the reviewer’s authority.

Outcome
A review finding, its accepted evidence and any accountable corrective actions.

12 · Prepare scoped operational reports

Coordinate scoped operational reports within Pharmacovigilance case intake and follow up.

Trigger
Scoped operational reports requires a new record, an agreed review or a controlled change.

Responsible role
Safety intake officer

  • Register scoped operational reports and its operating scope
  • Assign the accountable owner and required actions
  • Review the relevant evidence and unresolved conditions
  • Confirm the accepted outcome and retain its history

Approval
Reporting officer records the decision when the action changes an accepted commitment or requires delegated authority.

Exception handling
Required information or responsibility is missing, or an operating condition changes.

Outcome
A completed operating record with its linked evidence and remaining obligations.

Governance and control

  • Authoritative obligations and thresholds must be version-controlled.
  • High-risk cases require designated reviewer approval.
  • Automated alerts may prioritise but must not silently make accountable regulatory decisions.
  • Evidence and decision rationale must be retained.
  • Periodic reviews must be scheduled from risk and policy rules.
  • Jurisdiction-, regulator- or authority-specific rules must be configurable and validated by an authorised domain owner before production use.
Operating rules by business workflow
  • For safety report intake, the record retains an accountable owner, its supporting evidence and accepted outcome.
  • For source evidence records, evidence, reviewer authority and acceptance conditions are visible before a reviewed outcome is accepted.
  • For follow-up requests, the record retains an accountable owner, its supporting evidence and accepted outcome.
  • For medical review routing, evidence, reviewer authority and acceptance conditions are visible before a reviewed outcome is accepted.
  • For coding records, the record retains an accountable owner, its supporting evidence and accepted outcome.
  • For reporting task tracking, the record retains an accountable owner, its supporting evidence and accepted outcome.
  • For case closure review, evidence, reviewer authority and acceptance conditions are visible before a reviewed outcome is accepted.
  • For operating requirement, the accepted plan records assumptions, rejected alternatives, dependencies and conditions.
  • For operating exceptions, a decision retains its authority, reason, supporting evidence and resulting obligations.
  • For completion and follow-up, evidence, reviewer authority and acceptance conditions are visible before a reviewed outcome is accepted.
  • For controlled operating changes, evidence, reviewer authority and acceptance conditions are visible before a reviewed outcome is accepted.
  • For scoped operational reports, the record retains an accountable owner, its supporting evidence and accepted outcome.

Data, interfaces and operating requirements.

Core records

Obligation / ruleSubject / entityAssessmentAlert / issueReviewDecisionRemediationEvidence
Record fields and linked information
  • Record identifier — Stable reference for the operating transaction.
  • Site / programme — Business scope used for responsibility and reporting.
  • Operating subject — The request, commitment or work item being handled.
  • Accountable owner — Named responsibility for the next action.
  • Workflow stage — Current position in the agreed business journey.
  • Review requirement — Required review and outstanding decision.
  • Due or review date — Agreed action window or review trigger.
  • Linked evidence — Source records supporting the operating decision.
  • Decision authority — The delegated authority relevant to the accepted outcome.
  • Accepted outcome — Recorded decision and its business consequences.
  • Follow-up obligation — Remaining responsibilities after an accepted action.
  • Revision history — Trace of accepted changes and their evidence.
  • Safety report intake reference — Link the relevant safety report intake to the operating transaction and its decision evidence.
  • Source evidence records reference — Link the relevant source evidence records to the operating transaction and its decision evidence.
  • Follow-up requests reference — Link the relevant follow-up requests to the operating transaction and its decision evidence.
  • Medical review routing reference — Link the relevant medical review routing to the operating transaction and its decision evidence.
  • Coding records reference — Link the relevant coding records to the operating transaction and its decision evidence.

Systems and interfaces

  • Validated safety systems
  • Licensed terminology services
  • Approved reporting interfaces

Interface scope, data mapping and testing are agreed for each engagement.

Implementation requirements
Requires validated safety systems, licensed terminology and jurisdiction specific reporting rules; qualified reviewers determine causality, seriousness and reportability.

Mobile and tablet access

Responsive intake or reviewer access can be scoped under approved privacy and validation requirements.

Access approved workflows through the Dalfin mobile app. Device tasks and permissions are confirmed for the deployment.

Apple App Store ↗Google Play ↗

AI extensions

Prepare a draft evidence summary for medical reviewer confirmation. Causality, seriousness and reportability remain qualified-review decisions.

AI extensions are scoped around the required data, business outcome and review controls.

Engineered with Genesis.

Structured application engineering

Connect requirements, roles, records, workflows and interfaces through the agreed Genesis engineering process.

Controlled changes

Review dependency impact and validation requirements. Context Memory supports governed changes and accepted application revisions.

Deployment and support

Agree customer cloud or on-premises requirements, device access, implementation acceptance and ongoing engineering support.

AN EXAMPLE OPERATING SCENARIO

What to validate in a scoped demonstration.

A suspected adverse-event report lacks source information. The coordinator issues a follow-up request, the qualified reviewer records the medical assessment and approved coding, and the reporting officer tracks the authorised reporting tasks before closure.

What to review

  • A saved end-to-end transaction
  • An exception and its authorised resolution
  • Different operator, approver and reviewer permissions
  • Final records, history and the relevant report
Discuss this solution

Questions before implementation.

How is this system adapted to our organisation?

Roles, approval authority, business rules, records and reporting are configured around your operating model. Scope definition connects the required business outcome to workflows, interfaces and acceptance criteria.

How are approvals and responsibilities defined?

Operators, reviewers and authorised decision makers have defined responsibilities. Approval limits, exception handling and access permissions are agreed with your business owners and tested against the selected workflows.

Can it connect with our existing systems?

Interface requirements cover your existing business systems, data ownership, mapping and authentication. Connection design and testing form part of the agreed implementation scope.

What will we review in a solution walkthrough?

Start with a relevant business transaction, then review its approvals, an exception, role permissions and final records. Discuss the integrations, reporting and operating requirements that matter to your organisation.