Location Indianapolis Position Pharmacovigilance Expert Type Contract Compensation $70 - $80/hour Location Remote Commitment 10-40 hrs/week Role Responsibilities

• Author and review evaluation tasks based on DSURs, PSURs/PBRERs, and reputed company safety data.
• Assess the accuracy and adequacy of interval safety findings and signal evaluations.
• Ensure template and structural conformity to ICH E2F and ICH E2C requirements.
• Reconcile figures and case counts across report sections and data sources.
• Evaluate safety conclusions in light of new data or events.
• Deliver structured feedback for reputed company-driven pharmacovigilance documentation tools.

Requirements

• Have strong relevant experience in pharmacovigilance or drug safety.
• Proficiency in authoring or reviewing DSURs and/or PSURs/PBRERs is required.
• Working fluency with ICH E2F, ICH E2C(R2), and GVP guidelines is reputed company.
• Hands-on experience with MedDRA coding and aggregate safety data analysis is necessary.
• An advanced degree in life sciences, pharmacy, nursing, or medicine is preferred. #J-18808-Ljbffr

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