Pharmacovigilance Staffing for Drug Safety Teams on a 15-Day Clock
Case processors, drug safety scientists and safety physicians for pharma and biotech teams whose reporting clock keeps running through a vacancy.
Quick quiz. What day is it on the oldest serious case in your safety inbox?
Pharmacovigilance staffing places the case processors, drug safety scientists and safety physicians who keep a drug company’s adverse event reporting on time. KORE1 recruits them for pharma and biotech teams as contractors, contract-to-hire or direct hires.
Last updated: October 6, 2026
If the answer took more than a few seconds, you already know which seat is empty. A serious, unexpected adverse event has to reach FDA within 15 calendar days of the day anyone in your company first hears about it. Not the day it gets entered. The day it arrives.
That clock doesn’t pause for a resignation, a backlog or a vendor that missed a week. So drug safety hiring has a deadline built in, and the people you hire either protect it or spend it. Usually quietly.
- This desk
- Case intake and case processing, drug safety scientists, signal and aggregate report writers, safety physicians and medical reviewers, PV quality and compliance, and the managers who run a safety team or a safety vendor.
- Routed elsewhere
- Safety database configuration and validation go to our pharmaceutical IT staffing team, trial site and monitoring roles to clinical research staffing, and regulatory affairs seats run as their own search.
Pharmacovigilance is one desk inside KORE1’s life sciences staffing practice, next to the quality, manufacturing and lab searches. That matters more than it sounds, because a safety team leans on people from all three, and KORE1’s 92% twelve-month retention holds for drug safety hires as well.
The Seats Pharmacovigilance Recruiters Fill
Drug safety looks like one department from the outside. Inside, it’s four different jobs that hand the same case to each other. Same case, four desks.
Case intake and processing
Drug safety associates and case processors. They log the report, decide whether it’s a valid case, code the events, write the narrative and chase the follow-up. Most of the headcount lives here.
Medical review
Safety physicians and medical reviewers who judge seriousness, expectedness against the label and causality. Small group. Hard to find.
Safety science
Drug safety scientists who look across cases instead of at one. Signal detection, the periodic reports, the development safety update report for products still in trials, and the question of whether a pattern is real.
PV quality and operations
The people who own the SOPs, the training records, the vendor oversight and the inspection binder, so an auditor finds a system instead of a heroic analyst.
Titles drift between companies, so I screen for the work, not the label. A “drug safety specialist” at a big sponsor might never have written a narrative, while a case processor at a safety vendor has written thousands of them and coded every one against MedDRA. Hire for the desk.
One seat we don’t fill is the EU one. Europe’s good pharmacovigilance practices guidance requires a qualified person responsible for pharmacovigilance who lives and works in the EU, so we staff the U.S. team that feeds that person instead. Wrong side of the ocean.
Pharmacovigilance Staffing, Read on a Stopwatch
One serious, unexpected case and the desks it passes through before day 15. The split between desks is an example. The 15 is federal law.
- Day 0 to 1Intake and triage. Is it a valid case, is it serious, is it expected?
- Day 1 to 6Case processing. Data entry, event coding, the narrative, the follow-up request.
- Day 6 to 10Medical review. Causality and expectedness, signed by a physician.
- Day 10 to 15Quality check and submission. The case goes out electronically to FDA.
The rule is short. Under 21 CFR 314.80, a company with an approved drug must report each adverse event that is both serious and unexpected “as soon as possible but no later than 15 calendar days from initial receipt of the information.” Biologics get the same clock. Day 0 is receipt.
Watch the days. Medical review is the thinnest desk on most teams, because a sponsor might have two physicians signing off on everything, and when one of them takes a week of vacation in a launch year every case on the dial slides toward day 15 while case processors sit on finished work waiting for a signature.
So count desks, not heads. A team of twelve with one medical reviewer has a single point of failure. A team of eight with two doesn’t.
Follow-up has its own rule, which is why case processing is the widest arc. New information gets another 15 days, and if the reporter never answers, the same regulation expects records of the unsuccessful steps taken to get it. Somebody has to write those letters, log them and know when to stop. That’s a skill.
The other clocks a drug safety team runs
- 5 daysA distributor or partner named on the label that sends its serious reports to you, the applicant, has 5 calendar days from receipt to get them over.
- 7 daysIn clinical trials, an unexpected fatal or life-threatening suspected adverse reaction goes to FDA within 7 calendar days under 21 CFR 312.32. Other IND safety reports get 15.
- 30 daysEverything not sent as a 15-day report goes in a periodic report, quarterly for the first three years after approval, due 30 days after each quarter closes.
- 60 daysAfter those three years the periodic report goes annual, due 60 days after the approval anniversary.
- 10 yearsHow long the company keeps every adverse event record, raw data and correspondence included.
What Changed for Drug Safety Teams on October 1
Two things. One is old news that keeps getting bigger, and one went live last week.
The old news is who’s reporting. FDA’s adverse event database took in 1,307,769 reports dated 2025, and 625,389 of them came from consumers rather than doctors, pharmacists or nurses. That’s 48%. A consumer report is a phone call or a web form from someone who may not know the dose, the lot or what a liver panel is, so it’s longer to process and far more likely to need a follow-up.
The new part is the format. A Federal Register notice from April 2026 says that starting October 1, 2026, postmarketing case reports sent to FDA must use the ICH E2B(R3) data standards. FDA stopped taking the older R2 format after September 30. The database got a new name too, the Adverse Event Monitoring System, so the acronym on your job posts may need an update.
The database work belongs to your IT team. The people side is yours. Ask candidates about it.
- Walk me through a case where the Day 0 date was in dispute. Who won?
- Tell me about a follow-up letter that finally got an answer.
- Which coded term did you argue with a medical reviewer about last?
- Have you submitted in E2B(R3) yet, or only R2?
A strong case processor answers the first one with a date. A weak one answers with a feeling.
1,307,769
adverse event reports FDA received in 2025
657,530
of them arrived as expedited 15-day reports
48%
came from consumers, not health professionals
92%
of KORE1 placements stay past year one
From FDA adverse event data via openFDA, reports with a 2025 receipt date, data as of July 30, 2026. KORE1 retention data.
When Pharmacovigilance Staffing Should Be Contract
Safety volume isn’t steady. It jumps after a launch, a new indication, a label change, a recall or a news story, and it piles up whenever a vendor contract changes hands. None of those last forever. Volume comes in waves.
Put the volume on contract and the judgment on payroll. Experienced case processors on contract can clear a backlog and hold the clock through a launch without adding permanent headcount you’ll need to justify in eighteen months. FDA doesn’t care whose name is on the paycheck. It cares that the report was on time and that your written procedures covered the person who did it.
Keep judgment on your payroll. The safety physician, the lead scientist on signal work and the person who owns the inspection binder build up knowledge of your products that walks out the door with a contractor.
When I call a drug safety candidate, the conversation sounds like one between friends. Do they like the rhythm of a case queue, or do they want the one hard question nobody has answered yet? Both are good people. They belong at different desks, and an honest first conversation tells you which.
How Our Pharmacovigilance Recruiters Staff a Safety Team
Pick by how long the need lasts, then by the seat. Each card names the arrangement I’d start with.
Contract
Backlogs and launch surges
Case processors and intake staff who know the queue on day one and leave when volume settles.
Contract-to-hire
A safety team that’s growing
Associates and specialists who prove themselves on your SOPs before you add a permanent seat.
Direct hire
Scientists and physicians
Drug safety scientists, safety physicians and PV quality leads whose product knowledge should stay.
Confidential search
Heads of drug safety
Safety leaders approached quietly, often while the current head is still running the team.
Surge seats run through KORE1 contract staffing, a team still finding its size usually suits contract-to-hire, and the seats you mean to keep belong in direct hire. Senior safety leadership is a pharmaceutical executive search.
If the rest of the building is hiring too, our pharmaceutical recruiters handle quality and manufacturing seats, the pharmaceutical staffing agency desk covers contract plant and lab work, and biotech recruiters take the earlier-stage companies. Safety teams that sit on validated systems also hire through our life sciences IT staffing group, and our guide to hiring for regulated industries covers what changes when a regulator reads your records.
Common Questions
How does a pharmacovigilance staffing agency work?
A pharmacovigilance staffing agency finds the case processors, drug safety scientists and safety physicians a drug company needs, on contract or permanent. A good one screens for the work the seat does, not the title, because drug safety titles mean different things at different companies.
Is a case processor the same as a drug safety scientist?
Different jobs. A case processor works one report at a time, from intake to narrative to follow-up, against a deadline. A drug safety scientist looks across hundreds of cases for signals and writes the periodic reports. Some processors grow into scientists, and plenty prefer the queue.
Can a contractor process our safety cases?
Yes. The reporting duty stays with your company either way, so what matters is that the contractor works inside your written procedures and training records like any employee. Many sponsors already send all case processing to a safety vendor. Same idea, bigger scale.
Can you find us an EU QPPV?
Not for the EU seat itself. European guidance says the qualified person responsible for pharmacovigilance must reside and operate in the EU, or in Norway, Iceland or Liechtenstein, so a U.S. recruiter is the wrong tool. We staff the U.S. safety team that reports into that person.
Does the E2B(R3) change mean we need new people?
October 1, 2026 is when FDA began requiring E2B(R3) for postmarketing case reports, so mostly it means training the people you have. Where it changes hiring is the next case processor you bring in. Ask whether they’ve submitted in R3, because some have only worked in R2.
Should we staff drug safety on contract or direct hire?
Start with how long the volume lasts. Launch surges, backlogs and vendor changes end, so contract case processors fit them. Medical review, signal work and PV quality hold knowledge about your products for years, and those seats belong on your payroll. Most teams end up with both.
Tell Me How Old Your Oldest Case Is
Intake, processing, medical review or the science seat. Tell me which desk is short and how close your cases are running to day 15, and I’ll give you a straight read on the market for it.
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