Drug Safety Specialist | $80/hr Remote

• Author and review evaluation tasks based on DSURs, PSURs/PBRERs, and associated 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 AI-driven pharmacovigilance documentation tools.

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 associated 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 AI-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 essential.
• 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.