Pharmacovigilance Expert

$70–80/hrrate as listed

micro1 is contracting pharmacovigilance specialists to write and review evaluation tasks built from DSURs, PSURs/PBRERs, and case-level safety data used to train and test AI systems. The work centers on judging whether interval findings, signal evaluations, and benefit-risk conclusions hold up against ICH E2F and E2C(R2) expectations — and documenting exactly where they don't.

Summary, eligibility guidance and screening preparation are prepared by Sidequest from the platform's posting. Check the source listing before applying.

The work

You will spend most of your time doing two things: authoring evaluation tasks that a capable AI model should be able to reason through, and grading model or draft outputs against your own expert determination. Source material is aggregate safety documentation — Development Safety Update Reports, PSURs/PBRERs, signal evaluation summaries, line listings, and the case-level records behind them. A typical task might ask you to check whether cumulative and interval exposure figures reconcile across sections and appendices, whether a benefit-risk conclusion is actually supported by the data presented, or whether an expectedness determination is consistent with the reference safety information.

Write-ups matter as much as verdicts. A finding of "case counts don't reconcile" is only useful to the customer if you specify which sections, which figures, the likely source of the discrepancy, and whether it would be material to a regulatory reviewer. Expect to produce structured rationales, not checkbox scores. Reviewers on the project will push back on reasoning that is correct but unexplained.

What the screening measures

micro1's process is AI-led, with a conversational interview followed by domain tasks. It is looking for evidence you have owned aggregate reports end to end rather than contributed to one section — so be ready to describe specific reports you authored or reviewed, the therapeutic areas, the regulatory context, and decisions you made under time pressure. Expect follow-up questions that go a layer deeper than your first answer, particularly on ICH E2F versus E2C(R2) structural requirements, signal management workflow, MedDRA coding judgment, and how you handled a discrepancy you could not fully resolve. Writing clarity is assessed directly; short, vague answers screen poorly regardless of credentials.

Logistics

Contractor engagement, fully remote, no fixed hours.
Asynchronous task queues with per-batch deadlines; most contributors work in blocks of a few hours rather than full days.
Observed pay band for this listing is $70–80/hr, stated as observed and not guaranteed — actual rate depends on assessed depth, task type, and project stage.
Volume fluctuates with customer demand; treat it as supplemental rather than a replacement for primary work.
No prior AI or annotation experience expected.

What they look for

pharmacovigilance
drug safety report authoring
dsur/psur/pbrer review
ich e2f and ich e2c(r2) compliance
gvp guidelines
aggregate safety data analysis
signal management
benefit-risk assessment
meddra coding
seriousness and causality assessment
expectedness determination
data reconciliation
regulatory documentation
structured written communication
attention to detail

Before you apply

Would you pass this screen?

Drawn from what this listing actually requires. Answered in your browser — nothing is sent to us, and we do not store your answers.

Do you have at least 5 years of pharmacovigilance or drug safety experience in a sponsor, CRO, or as an independent consultant?
Pharmacovigilance or drug safety experience · required
Have you authored or led the review of at least one complete DSAR (Development Safety Update Report) or PSUR/PBRER (Periodic Safety Update Report or Periodic Benefit-Risk Evaluation Report) from initiation through delivery?
DSAR or PSUR/PBRER authoring or review · required
Do you hold an advanced degree in life sciences, pharmacy, nursing, or medicine (PharmD, MD, MSc, or equivalent)?
Life sciences degree · preferred
Do you have working knowledge of ICH E2F and ICH E2C(R2) safety reporting guidelines and their application to regulatory pharmacovigilance documents?
ICH E2F and E2C guideline fluency · required
Do you have hands-on experience with MedDRA coding, seriousness assessment, causality assessment, and expectedness determination in aggregate safety data?
MedDRA coding experience · preferred
Are you able to work remotely and communicate clearly in writing and verbally in English on complex safety topics?
Remote work and communication · required

0 of 6 answered

Included with this listing

Interview prep — 10 questions

Matched to what this platform's screening actually measures. Answer each out loud in 60–90 seconds: claim → concrete example → implication.

What it tests: Testing whether the candidate has genuinely written or reviewed these documents end-to-end, not just touched them. Pharmacovigilance credibility rests on real report ownership and judgment under regulatory pressure.
A strong answer: A concrete example naming the drug, indication, and a specific safety decision (signal classification, benefit-risk trade-off, or data inconsistency resolved)—showing they shaped the narrative, not just checked boxes. Should reveal how they weighed evidence and justified conclusions.
Where people lose it: Vague language like 'helped with safety reporting' or describing only data collection/entry tasks, not actual evaluation judgment. Inability to recall specific findings or explain the reasoning behind a conclusion signals document familiarity without deep ownership.