Pharmacovigilance Expert

What you'll do

This is aggregate safety report review, pointed at AI tools that will help draft them. You write and review evaluation tasks built on DSURs, PSURs/PBRERs, and the safety data and case-level records underneath them. The checks are the ones a safety lead runs before sign-off:

• Are the interval safety findings, signal evaluations and benefit-risk conclusions accurate and adequate?
• Does the report conform to ICH E2F and ICH E2C: the right section content, cumulative versus interval data presented correctly, appendices complete?
• Do figures and case counts reconcile across sections and sources, and which discrepancies would matter to a regulator?
• Do the safety conclusions still hold in the light of new data or events?

Each call gets a structured written rationale, and your feedback shapes the AI tools being built for PV documentation and analysis.

Reconciliation is where PV experience counts most. Models are prone to case counts that drift between the executive summary and the tabulations, and catching that requires someone who has chased the same discrepancy through a real report.

Who fits

• At least five years in pharmacovigilance or drug safety at a sponsor, CRO or as an independent consultant
• Authoring or reviewing DSURs and/or PSURs/PBRERs end to end
• Working fluency with ICH E2F, ICH E2C(R2) and GVP, including signal management and benefit-risk methodology
• Hands-on MedDRA coding, seriousness and causality assessment, expectedness determination and aggregate data analysis
• Skill at reconciling aggregate data against case-level information
• An advanced degree in life sciences, pharmacy, nursing or medicine (PharmD, MD, MSc or equivalent)

Both development-stage and post-marketing experience, QPPV or deputy QPPV roles, safety committee work or AI-assisted safety review tools are pluses.

What it pays

$70–80/hour, micro1's published figure, with a tight band. It is above micro1's $30–60 Medical Writer (Pharmaceutical) listing, which covers overlapping DSUR and PSUR material from the writing side, and well below the $160–200 oncology clinician listing, which needs a practising specialist. No compensation structure, weekly hours or duration is stated.

Worth knowing

Good:

• Forty openings, flagged high demand
• A narrow, predictable band
• Nursing degrees count alongside pharmacy and medicine
• Independent PV consultants explicitly qualify

Less good:

• End-to-end aggregate report experience is a firm filter; case processing alone is not enough
• No hours, duration or pay structure published
• Posted two months ago; check it is still open
• Contractor engagement: no benefits, no notice period, your own tax to manage

About this listing

Posted by micro1 on its own jobs portal and read on 24 September 2026. The $70–80/hour band, forty openings, five-year floor and guideline list are its own published text. Location is given only as remote with no country restriction, so eligibility is left open. Payment terms and schedule are not published on the listing. Related: Medical Writer (Pharmaceutical). See micro1.