Pharmacovigilance Expert, Drug Safety & Regulatory Compliance
Overview
You will own the safety signal evaluation and regulatory documentation for an AI-driven healthcare project. Work with a cross-functional team of data scientists and clinicians to review, evaluate, and refine DSURs, PSURs/PBRERs, and safety data. No prior AI experience is required, but your expertise in GVP guidelines and ICH E2F/E2C(R2) standards will drive accurate, compliant content. This remote contractor role lets you apply your drug safety knowledge to shape next-generation AI tools while maintaining the highest quality standards.
What You'll Do8
- 1Author and review evaluation tasks based on DSURs, PSURs/PBRERs, safety data, and case-level records.
- 2Assess safety findings and signal evaluations against regulatory requirements and ICH E2F/E2C(R2) standards.
- 3Reconcile aggregate safety data across sources, resolving case count and figure inconsistencies.
- 4Evaluate benefit-risk conclusions and signal management strategies for new data and events.
- 5Provide structured written feedback and rationales to improve AI-driven pharmacovigilance tools.
- 6Ensure accuracy and completeness of safety documentation, adhering to GVP guidelines and MedDRA coding.
- 7Drive quality improvements by identifying and correcting discrepancies in safety reports.
- 8Collaborate with team members to refine evaluation criteria and maintain regulatory alignment.
Requirements7
- 15+ years in pharmacovigilance or drug safety within a sponsor, CRO, or consulting environment.
- 2Proven experience authoring or reviewing DSURs and/or PSURs/PBRERs.
- 3Strong knowledge of ICH E2F, ICH E2C(R2), and GVP guidelines.
- 4Hands-on experience with signal management, benefit-risk assessment, MedDRA coding, and safety data analysis.
- 5Experience reconciling aggregate safety data with case-level information.
- 6Advanced degree in life sciences, pharmacy, nursing, medicine, or related fields (PharmD, MD, MSc, or equivalent).
- 7Experience in clinical development safety, post-marketing surveillance, QPPV/deputy QPPV roles, safety committees, or AI-assisted safety review tools is a plus.
Salary Insight
$146 - $166k per year
Location
Required Skills
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