Pharmacovigilance Expert Focused on DSUR PSUR Review and ICH Compliance
Overview
The role brings seasoned pharmacovigilance know‑how to a remote, contractor engagement for a key client project. You’ll author and review complex safety documents such as DSURs, PSURs, and PBRERs, while ensuring alignment with ICH guidelines and GVP. Your input will also help shape AI-driven tools for safety documentation by providing high‑quality, real‑world feedback. A strong emphasis on precise written communication and data integrity drives success in this position, which centers on detailed evaluation, reconciliation, and justification of safety conclusions. DSURs, PSURs, PBRERs, ICH E2F/E2C(R2), and MedDRA familiarity are core to daily work.
What You'll Do5
- 1Author and review evaluation tasks tied to DSURs, PSURs/PBRERs, and related safety data and case records.
- 2Apply expert judgment to verify the accuracy of safety findings, signal reviews, and benefit‑risk conclusions per industry best practices.
- 3Check templates and structure against ICH E2F and ICH E2C requirements, ensuring correct data presentation and complete appendices.
- 4Reconcile numbers across report sections and data sources, flagging discrepancies relevant to regulatory review.
- 5Provide clear written rationales when safety conclusions change in light of new data, and offer structured feedback to help develop AI‑driven pharmacovigilance tools.
Requirements7
- 15+ years in pharmacovigilance or drug safety with sponsor, CRO, or independent consultancy experience.
- 2Proven track record authoring or reviewing DSURs and/or PSURs/PBRERs from start to finish.
- 3Fluency with ICH E2F, ICH E2C(R2), and GVP guidelines, including signal management and benefit‑risk assessment methods.
- 4Hands‑on MedDRA coding, seriousness and causality assessment, expectedness determination, and aggregate safety data analysis.
- 5Experience reconciling aggregate safety data with case‑level information to spot inconsistencies.
- 6Advanced degree in life sciences, pharmacy, nursing, or medicine (PharmD, MD, MSc, or equivalent).
- 7Experience in development‑stage and post‑marketing safety reporting; QPPV or deputy QPPV roles, safety committee participation, or AI‑assisted safety review tools is a plus.
Who Should Apply
The ideal candidate brings at least five years of hands‑on pharmacovigilance experience and a proven ability to author or review DSURs and PSURs end‑to‑end. You should be comfortable navigating ICH E2F and E2C(R2) standards and translating complex safety data into clear rationales. This role suits professionals who value data quality, meticulous documentation, and the chance to influence AI tooling in safety reviews. It is less suitable for someone without extensive drug safety reporting experience or those who struggle with structured scientific writing. Common reasons for a lower fit include limited exposure to DSUR/PSUR cycles and weaker proficiency with MedDRA coding or regulatory reconciliation tasks.
Salary Insight
Pay is $70 - $80 per hour. Pay terms are discussed later in the process.
Location
Required Skills
Application Tip
Highlight DSUR/PSUR/PBRER experience in your resume, and quantify accuracy improvements or time saved on safety document reviews to demonstrate your fit for AI‑assisted safety tooling.
See NearSkill jobs more often in your search
How your application is processed
1Application received
Your resume and details are logged the moment you apply.
2ATS + eligibility screening
We check your profile against the role’s skills, seniority, and requirements.
3Employer sees qualified profiles only
Only candidates who clear screening move forward.
Similar open positions
Explore active roles that match your skills and interests.
Mercor
VerifiedMedical Safety Expert
This project pairs medical safety expertise with AI evaluation. You will build and validate the safety layer of clinical data rooms, covering adverse event data, SAE records, patient narratives, discontinuations, and protocol deviations. You will also author complete DSURs and PBRERs and design prompt sets, golden outputs, and grading rubrics that measure how well an AI agent reproduces pharmacovigilance work. The role requires an MD, PharmD, or PhD and prior authorship of both pre- and post-commercial aggregate reports. Work is remote and paid hourly at $140-$190 per hour.
Micro1
VerifiedMedical Writer for Regulatory CSR and AI Tool Training
Remote contractor role shaping AI-assisted clinical writing tools through real-world input. You’ll author and review regulatory documents such as Clinical Study Reports, DSURs, and PSURs to train AI systems. Your domain expertise drives how models learn and reason about clinical content, with emphasis on accuracy and structure. Expect to work with ICH E3 guidelines, eCTD placement, and TFL analysis to guide model behavior. Oncology and haematology experience adds value on multiple projects.
Micro1
VerifiedRegulatory Affairs Specialist for AI Regulatory Docs
Remote contractor role focused on regulatory documentation for an AI-oriented project. You’ll apply deep regulatory expertise to evaluate, draft, and critique responses aligned with agency expectations. The work centers on clinical documentation review, CTD/eCTD structure, and interactions with health authorities, shaping how AI models learn from real-world regulatory input. You don’t need AI experience, just solid domain knowledge and precise written communication. Bold ICH guidelines, CTD/eCTD and health authority interactions in your day-to-day work.
Mercor
VerifiedPharmacologist
This remote contract role places a clinical pharmacologist at the center of an AI evaluation pipeline. You will build the pharmacology layer for synthetic data rooms, producing PK/PD datasets, dose escalation schemes, and bioanalytical reports that are defensible under expert review. You will also author dose rationale documents and interaction sections, then design prompts, golden outputs, and scoring rubrics that measure whether an AI agent can replicate your work. The engagement runs 20 to 30 hours per week and pays an hourly rate.
Micro1
VerifiedPharmacology Expert for AI Training Remote Contract
A remote contract role for a Pharmacology Expert to help train next generation AI systems. You will review pharmacology content for accuracy, build scenarios and datasets around pharmacokinetics, pharmacodynamics, and drug interactions, and provide expert feedback on AI-generated pharmacology responses. Your domain knowledge takes priority, no AI background required.
Micro1
VerifiedClinician Oncology Hematology Expert for AI Healthcare Project
A remote contractor role for an experienced clinician in oncology or hematology to support a customer project at the intersection of AI and healthcare. You’ll review and author evaluation materials, judge the clinical defensibility of efficacy and safety conclusions, and ensure reported endpoints align with real-world clinical significance. You will translate complex clinical reasoning into clear, guideline-based rationales for non-clinical audiences using your domain knowledge and structured documentation. Key focus areas include dose escalation decisions, adverse event grading, and detailed outcome endpoints across oncology and hematology trials. CTCAE, RECIST, and Lugano criteria are core tools in this work.