Pharmacovigilance

We support the individual case safety report from receipt through preparation for submission. The steps we can take on are intake, triage, data entry, MedDRA and WHO-DD coding, narrative drafting, quality check, and submission support.

Cases may be spontaneous, solicited, from literature, or from clinical trials, when your procedures include that source. Seriousness, expectedness, and causality follow your conventions. Medical review stays with the reviewer your procedure names.

We support screening of the literature sources and search strategies you approve, identification of reports that meet your case criteria, and a documented decision to process or to exclude.

Hits that meet your case definition are handed to ICSR processing. We do not claim a proprietary literature database.

We support drafting and update of periodic aggregate safety reports from the data cuts, line listings, and templates you provide.

Report types we support include PSUR/PBRER, DSUR, and PADER. Sign-off remains with the safety physician or other role your procedure names. We draft. We do not approve the benefit-risk conclusion in your place.

We support signal detection and the path after a signal is seen: case-series review, validation, assessment, and tracking through to a decision you record.

Sources can include your case data, literature, and other datasets you make available. A signal is not communicated to an authority, an investigator, or the public except through the path in your signal procedure.

We support risk management plans: drafting and update of safety concerns, pharmacovigilance activities, and risk-minimisation measures so they match the safety profile you hold.

Approval of the plan, and any commitment it creates, stays with your safety governance.

We support qualified-person and local safety activities: deputy and local-contact tasks, procedure maintenance, and the document chase that an inspection requires, where you have appointed people to those roles.

A listing on this page is not an appointment. A QPPV is named in your pharmacovigilance system and accepted by the relevant authority. ForeMed does not state that it holds that appointment.

We support day-to-day work in the safety database you license and host: case entry, workflow queues, and reconciliation tasks your administrators define.

ForeMed does not claim a licence to any safety database. Configuration changes that affect validation are proposed, not applied, unless your change-control says otherwise.

We support pharmacovigilance audits of partners, affiliates, or internal processes: planning, sampling, interviews, and a findings report mapped to your procedure.

An audit report is a set of findings. It is not a certificate, and it is not an inspection outcome.