Clinical Safety Specialist – Remote, $70‑$80/hr

About the role

The Clinical Safety Specialist will support pharmacovigilance activities on a contract basis, working remotely to author and review safety evaluation documents such as DSURs, PSURs and PBRERs.

Key responsibilities

• Author and review evaluation tasks based on DSURs, PSURs/PBRERs, and associated safety data.
• Assess accuracy and adequacy of interval safety findings and signal evaluations.
• Ensure templates and structure comply with 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.
• Provide structured feedback for AI‑driven pharmacovigilance documentation tools.

Required profile

• Strong experience in pharmacovigilance or drug safety.
• Proficiency in authoring or reviewing DSURs and/or PSURs/PBRERs.
• Working fluency with ICH E2F, ICH E2C(R2) and GVP guidelines.
• Hands‑on experience with MedDRA coding and aggregate safety data analysis.
• Advanced degree in life sciences, pharmacy, nursing or medicine preferred.

Required skills

• MedDRA coding
• DSUR authoring
• PSUR/PBRER authoring
• ICH E2F compliance
• ICH E2C(R2) compliance
• GVP guideline application