Carry safety signals into product action

Link an assessed signal to complaint investigations, labeling, regulatory commitments and distributor communication. PV and medical owners decide escalation while QA and RA assess affected markets.

An inspection, incident, assessed signal or proposed operating change requires action.

People in the process

PPharmacovigilanceProcess Owner
MMedical AffairsParticipating Team
QQuality AssuranceParticipating Team
RRegulatory AffairsParticipating Team
LLegalParticipating Team

Records it works with

Inspection or incident record
Applicable controls, conditions and approved procedures
Technical findings, photographs and remediation records

The process is a starting point.The standards are yours.

Configure by product, authorisation and destination market. Regulatory Affairs and authorised quality personnel retain product-change, submission and batch-release decisions. Safety reporting and UCPMP requirements use the applicable reviewed scope.

Keep the work connected.

Pharmacovigilance

Complete safety cases with source-preserving follow-up

Connect the original report, product/batch details, follow-up questions and case assessment in the safety system. PV specialists decide seriousness, causality and market reporting; Rilin tracks missing inputs and handoffs.

MRD

Regulatory Affairs

Scope a product change across registered markets

Map proposed site, process, formula or specification changes to product dossiers, approved manufacturers and target markets. Regulatory affairs determines each filing route and implementation gate with QA before commercial rollout.

QMR

Regulatory Affairs

Reconcile approved artwork with every market version

Link label text, pack size, registration conditions and artwork proofs to the countries and batches concerned. Regulatory and QA approve cutover and stock disposition before packaging changes.

QPC

Explore all Pharma processes.

Order for the work. Room for the people.