Pharmacovigilance Expert (Remote)
$70 – $80 / hour | Remote | Contract (40 Openings)
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Overview:
SourceBridge Co. is engaging Pharmacovigilance Experts to contribute their advanced drug safety expertise to a key customer project. In this role, you will apply your domain expertise to help train next-generation AI systems. Your work will directly 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 most. This opportunity is ideal for professionals experienced in authoring and reviewing complex safety reports who are passionate about data quality and committed to clear documentation.
Responsibilities:
- Author and review evaluation tasks based on DSURs, PSURs/PBRERs, and associated safety data and case-level records.
- Apply expert judgment to assess the accuracy and adequacy of interval safety findings, signal evaluations, and benefit-risk conclusions in alignment with best practices.
- Assess template and structural conformity to ICH E2F and ICH E2C requirements, including section content, cumulative vs. interval data presentation, and completeness of appendices.
- Reconcile figures and case counts across report sections and data sources, identifying and documenting discrepancies significant for regulatory review.
- Evaluate safety conclusions in light of new data or events, providing clear, structured written rationales supporting your determinations.
- Deliver structured feedback to inform the development of AI-driven tools for pharmacovigilance documentation and analysis.
Requirements:
- Core expertise in pharmacovigilance, drug safety report authoring, aggregate safety data analysis, signal management, and benefit-risk assessment.
- In-depth knowledge of ICH E2F, ICH E2C(R2) compliance, GVP guidelines, MedDRA coding, seriousness/causality assessment, and expectedness determination.
- Proven ability in regulatory data reconciliation and structured written communication with exceptional attention to detail.
Preferred Qualifications:
- 5+ years of pharmacovigilance or drug safety experience at a sponsor, CRO, or as an independent consultant.
- Demonstrated proficiency in authoring or reviewing DSURs and/or PSURs/PBRERs from start to finish.
- Advanced degree in life sciences, pharmacy, nursing, or medicine (PharmD, MD, MSc, or equivalent).
- Experience in both development-stage and post-marketing safety reporting, QPPV/deputy QPPV roles, safety committee participation, or exposure to AI-assisted safety review tools.
Benefits:
- Competitive hourly rate ($70–$80/hr).
- 100% remote flexibility.
- Opportunity to apply drug safety and regulatory expertise toward building cutting-edge pharmacovigilance technology.
Hiring Process:
- Application Review: Evaluation of drug safety experience, safety report authoring history, and life sciences credentials.
- AI Assessment: Practical review of DSUR/PSUR analysis, MedDRA/ICH compliance understanding, and reconciliation precision.
- Onboarding: Remote project integration and setup.
Why Join Us?
Partnering with SourceBridge Co. offers you a unique opportunity to monetize your pharmacovigilance and drug safety background on a flexible schedule. You will work alongside top industry professionals to train future AI models that streamline regulatory compliance, safety report accuracy, and risk assessment protocols.
Apply Now: