Drug Safety Specialist | $80/hr Remote
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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