Drug Safety Professional: what the role actually involves
A drug safety, or pharmacovigilance, professional receives, assesses and processes reports of adverse events associated with a study drug or marketed product, and helps make sure serious events are reported to regulators within required timelines.
This role sits in the pharmacovigilance and drug safety pathway.
What this role involves
- Receiving and triaging adverse event reports from sites, patients or literature
- Assessing case seriousness, causality and expectedness against the reference safety information
- Coding adverse events and medications using standard dictionaries such as MedDRA and WHODrug
- Preparing individual case safety reports (ICSRs) for regulatory submission
- Tracking expedited and periodic reporting timelines
- Contributing safety data to periodic reports such as DSURs or PBRERs
Where this role sits in drug development
Drug safety work runs continuously from early clinical development through post-marketing, since adverse events must be monitored and reported for as long as a product is being studied or sold.
BORAKA pathways for this role
- Explore BORAKA Academy
Role-mapped learning for case processing and safety reporting.
Go - See how assessment works
Case-processing casebooks scored against a rubric.
Go - Get a role readiness report
A structured look at readiness against drug safety work.
Go - Explore Careers
Career strategy for professionals targeting pharmacovigilance roles.
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Frequently asked questions
What is pharmacovigilance?
Pharmacovigilance is the science and practice of detecting, assessing, understanding and preventing adverse effects associated with medicines. Drug safety professionals carry out the case-level and signal-level work this requires.
What is an ICSR?
An individual case safety report (ICSR) is the structured report of a single adverse event, containing the patient, event, product and reporter information needed for a safety assessment and, where required, regulatory submission.
What are MedDRA and WHODrug?
MedDRA is a standard dictionary used to code adverse events and medical history terms consistently. WHODrug is a standard dictionary used to code medication names. Consistent coding lets safety data be aggregated and analyzed across cases.
What does 'expedited reporting' mean?
Expedited reporting refers to the requirement to report certain serious and unexpected adverse events to regulators within a short, defined timeline, separate from routine periodic safety reporting.
Does drug safety work require a clinical or scientific background?
Many drug safety professionals have a nursing, pharmacy or life-sciences background, since case assessment involves clinical judgment. Specific requirements are set by each employer.