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Micro1
Remote Pharmacovigilance ExpertMicro1 • North Augusta, South Carolina, US
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Remote Pharmacovigilance Expert

Remote Pharmacovigilance Expert

Micro1 • North Augusta, South Carolina, US
24 days ago
Salary
$70.00 hourly
Job type
  • Full-time
  • Remote
Job description

Pharmacovigilance Expert

$70 - $80/hourpay

Required Skills

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

About micro1

micro1 is the leading AI data lab for training frontier models and evaluating AI agents. Experts contribute their diverse subject matter knowledge across domains such as finance, healthcare, STEM engineering, and more. micro1 transforms that real-world expertise into high-quality training data, evaluations, and feedback loops that improve how AI systems learn, reason, and perform.

Our platform identifies and vets top talent through an AI recruiter, enabling high-quality expert contributions at scale. We aim to enable 1 billion people to do meaningful work by applying their expertise to AI. As our global expert network grows, micro1 is building the human intelligence layer for frontier AI.

Role Title: Pharmacovigilance Expert


Role Type: Contractor


Location: Remote


micro1 is engaging Pharmacovigilance Experts to contribute their advanced drug safety expertise on a key customer project. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required — your domain knowledge is what matters. This opportunity is ideal for professionals experienced in authoring and reviewing complex safety reports, passionate about data quality, and committed to clear written and verbal communication.


Scope of Work

  1. Author and review evaluation tasks based on DSURs, PSURs/PBRERs, and associated safety data and case-level records.
  2. Apply expert judgment to assess the accuracy and adequacy of interval safety findings, signal evaluations, and benefit-risk conclusions in alignment with best practices.
  3. Assess template and structural conformity to ICH E2F and ICH E2C requirements, including proper section content, presentation of cumulative versus interval data, and completeness of appendices.
  4. Reconcile figures and case counts across report sections and data sources, identifying and documenting discrepancies significant for regulatory review.
  5. Evaluate safety conclusions in light of new data or events, and provide clear, structured written rationales supporting your determinations.
  6. Deliver structured feedback to inform the development of AI-driven tools for pharmacovigilance documentation and analysis.


Preferred Qualifications

  1. 5+ years of pharmacovigilance or drug safety experience at a sponsor, CRO, or as an independent consultant.
  2. Demonstrated proficiency in authoring or reviewing DSURs and/or PSURs/PBRERs from start to finish.
  3. Working fluency with ICH E2F, ICH E2C(R2), and GVP guidelines, including signal management and benefit-risk assessment methodology.
  4. Hands-on experience with MedDRA coding, seriousness and causality assessment, expectedness determination, and aggregate safety data analysis.
  5. Expertise in reconciling aggregate safety data and identifying inconsistencies with case-level information.
  6. Advanced degree in life sciences, pharmacy, nursing, or medicine (PharmD, MD, MSc, or equivalent).
  7. Experience in both development-stage and post-marketing safety reporting, QPPV or deputy QPPV roles, safety committee participation, or AI-assisted safety review tools is a plus.
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Remote Pharmacovigilance Expert • North Augusta, South Carolina, US

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