Your Actual Job — The 11-Step Workflow & Global Reporting Deadlines

Every single case, in every PV department on earth, moves through the same 11 steps: receipt of the source document, triage against the four minimum validity criteria, Day-0 determination, book-in to the safety database with a unique case number, full data entry, MedDRA coding of the event, WHO Drug Dictionary coding of the suspect and concomitant drugs, narrative writing, quality check, medical review (where causality assessment is formally applied), and submission to the regulator in E2B(R3) format. The deadlines change by country. The destination changes. The workflow does not.

Because ICH E2A — the foundational guideline on expedited safety reporting — was adopted by the major regulatory regions decades ago, the core timelines are remarkably harmonised globally. The universal baseline is 7 calendar days for fatal or life-threatening SUSARs (with a complete follow-up within an additional 8 days), and 15 calendar days for other serious SUSARs and for serious post-marketing ADRs. The US FDA’s IND Safety Report framework mirrors this exactly for clinical trials, and its 15-day Alert Reports apply the same logic post-marketing — with one narrow exception worth knowing: certain non-prescription (OTC) products marketed without an approved application get 15 business days rather than calendar days. The EU applies the same 7/15-day structure to EudraVigilance submissions, and India follows the same ICH E2A-aligned timelines under the 2019 New Drugs and Clinical Trials Rules, reporting to CDSCO and PvPI.

This matters more than it seems: missing one of these deadlines is not a minor administrative slip — it’s an audit finding, and repeated late submissions can trigger regulatory action against the entire company, not just the individual case. That’s why, on day one of any PV job anywhere in the world, the first thing you’re trained on is your company’s tracking system for these deadlines.

It’s worth sitting with just how uniform this workflow really is. A drug safety associate in Bengaluru processing a case for a US-marketed product runs through the exact same 11 steps as a colleague in a European CRO handling an EU-marketed drug — the databases might say Argus instead of Vault Safety, the destination might say EudraVigilance instead of the FDA gateway, and the deadline clock might read 15 calendar days instead of 15 business days for that narrow US OTC exception — but the shape of the job, step for step, doesn’t change. That uniformity is exactly what makes PV skills so portable across companies, countries, and even CRO client accounts.