Reimagine trial coordination, pharmacovigilance, and regulatory submissions.
Three roles in pharma ops, where people and AI work together
Illustrative work to adapt to your enterprise. Define the records, review rules and checks for your project.
Clinical trial coordination
Responsibilities to review
- Read the protocol and prior deviations
- Review site monitoring notes
- Draft the deviation note with classification
- Draft the corrective action plan
AI can compare protocol extracts, deviation records and monitoring notes and draft a deviation summary. The clinical operations coordinator verifies source references and missing facts against the approved SOP. The authorized quality or clinical reviewer determines classification, corrective action and sign-off; the draft does not establish GxP compliance.
Pharmacovigilance case processing
Responsibilities to review
- Read the adverse event report
- Review proposed MedDRA terms
- Review source evidence for the qualified causality assessment
- Draft the seriousness call
AI can organize an adverse-event report, suggest MedDRA terms and draft an evidence-linked case summary. A qualified pharmacovigilance reviewer checks every proposed coding, seriousness and causality assessment against the source. The authorized PV owner determines reportability and signs off on submission or escalation under the applicable procedure.
Regulatory submission
Responsibilities to review
- Read the source data packages
- Review prior submissions and agency guidance
- Draft the submission section with cross-references
- Build traceability and cross-reference index
AI can draft a submission section from approved source packages and supplied agency guidance, retaining cross-references. The regulatory specialist checks each material claim, completeness and traceability. The authorized regulatory owner resolves discrepancies and signs off before submission; preparation does not establish agency acceptance.
Counts from selected roles in our job-posting dataset, read 2026-10-24. They describe source coverage, not industry totals, client engagements or operating outcomes. Current reviewed-example availability is shown separately below.
Reference workflows to adapt to your organization
Explore these reference workflows and adapt one to your organization. See a proposed division of work between people and agents, with decisions, responsibilities and handoffs. Task Intelligence provides the detail behind the redesign.
Quality Management
Explore deviation, CAPA and change-review preparation. Qualified quality owners review source evidence and retain regulatory and release decisions.
Talent Acquisition
Explore sourcing and credential-evidence preparation for clinical and regulatory hiring. Authorized recruiters verify evidence and make selection decisions under approved hiring rules.
Procure-to-Pay
Explore supplier-document review and purchase preparation. Agree qualification requirements, controlled-material restrictions and human authorization for orders and payment release.
Maintenance (Preventive/Predictive)
Explore maintenance-evidence preparation for laboratory and manufacturing equipment. Qualified owners determine validation requirements and approve work under the applicable procedure.
Make this work real in your enterprise.
Choose an example above or bring work from your own team. Decide what should change and what people and agents will produce. Agree the records, tools and practice cases needed to build, configure and test it. Nuvepro scopes the bespoke project, environment and preparation with you. Your enterprise names who checks the result and who will operate it.
Reviewed AI-support or automation examples are not yet published for this selection. Discuss your workflow →
How we work with pharma orgs
Start with your clinical, pharmacovigilance, regulatory and quality owners. Choose actual work such as deviation review, adverse-event preparation or submission drafting, agree the intended change and scope a bespoke project around your approved source packages, SOPs and qualified review gates. Your team builds or configures the agreed solution; Nuvepro supplies scoped projects, environments and preparation. The 6 to 8 week AI Bootcamp is one preparation option. Integration, rollout and ongoing operation are separately agreed, with your enterprise owning operating acceptance.
Want a pharma-specific walkthrough?
Bring one workflow, your stack and the people responsible. Discuss what changes, what your team would build or configure and how the owners would check and accept the result.
Book a time