Pharmacovigilance Expert - Remote
YO AI Labs
Job Description
Job Description
Job Title: Pharmacovigilance Expert
Job Type: Contractor
Location: Remote
We are seeking experienced Pharmacovigilance Experts to support an AI healthcare project by reviewing drug safety documentation, evaluating regulatory content, and improving AI-generated outputs. No AI experience is required—your pharmacovigilance expertise is what matters.
Key Responsibilities- Review and author DSURs, PSURs/PBRERs, and safety reports.
- Evaluate safety signals and benefit-risk assessments.
- Ensure compliance with ICH E2F, ICH E2C(R2), and GVP guidelines.
- Analyze aggregate safety data and reconcile case information.
- Review MedDRA coding, causality, seriousness, and expectedness.
- Provide structured feedback to improve AI-generated content.
- Maintain high standards of quality and regulatory compliance.
- Pharmacovigilance
- Drug Safety
- DSUR/PSUR/PBRER Review
- ICH E2F & ICH E2C(R2)
- GVP Guidelines
- Signal Management
- Benefit-Risk Assessment
- MedDRA Coding
- Safety Data Analysis
- Regulatory Documentation
- Strong Written Communication
- Attention to Detail
- 5+ years of pharmacovigilance or drug safety experience.
- Experience with DSURs, PSURs/PBRERs, and aggregate safety reports.
- Strong knowledge of ICH E2F, ICH E2C(R2), and GVP.
- Experience with signal management and safety data review.
- Degree in Pharmacy, Medicine, Nursing, Life Sciences, or related field.
- Experience in clinical safety, post-marketing surveillance, or CRO/pharmaceutical environments is a plus.
Vacancy posted 16 days ago
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