Inside Safety Watch

What this team does

Collects every side effect reported in a study or after a drug is sold.

Decides how serious it is, whether it is expected, and reports it on time.

Watches the pattern across thousands of reports for a signal nobody saw yet.

A day here

1. 8:00Twelve new cases in the inbox. One is a hospital stay reported late on Friday.
2. 9:00Day 14 of 15 for that case. It goes first.
3. 11:30The site report is missing the start date of the event. You query the site and call the CRA.
4. 14:00The medical reviewer agrees it is unexpected. It goes to the regulator today.
5. 16:00Signal meeting. Three cases of the same rash. Not enough yet, but you start watching.

Roles, junior to senior

• Drug safety associate
• Safety scientist
• Medical reviewer or medical monitor
• Safety reporting lead
• Head of pharmacovigilance

1. Drug safety associateEntering and checking cases, from first report to follow-up.PharmacovigilanceParticipant Safety and Safety ReportingClinical Systems and Data Workflow
2. Safety scientistCase review, aggregate reports and looking for signals.PharmacovigilanceParticipant Safety and Safety ReportingRegulatory and Essential Records
3. Medical reviewer or medical monitorThe medical call on seriousness, expectedness and what to do next.PharmacovigilanceParticipant Safety and Safety ReportingProtocol Interpretation
4. Safety reporting leadWho gets which report by when, in every country.PharmacovigilanceParticipant Safety and Safety ReportingRegulatory and Essential RecordsQuality
5. Head of pharmacovigilanceThe safety system, the inspections and the person regulators call.PharmacovigilanceParticipant Safety and Safety ReportingQualityCommunication

Who they talk to every day

• The Clinic
• Site 204
• Reg House
• Data Works
• City Hall

Words you will hear

PV

Pharmacovigilance. The work of finding and reporting drug side effects.

SUSAR

A serious side effect that might be caused by the drug and was not expected.

Day 0

The day anyone in the company first heard about the case. The clock starts here.

Expectedness

Whether the side effect is already listed in the drug's documents.

MedDRA

The shared dictionary of words used to code side effects.

Signal

A pattern in reports that might mean a new risk.

DSUR

The yearly safety report for a drug still in trials.

Common moves in and out

Nurses, pharmacists and life science graduates move in most often.

From here people go into signal work, safety leadership, regulatory or medical affairs.