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

About the role

We are seeking a Clinical Safety Specialist to support pharmacovigilance activities on a contract basis. The role is fully remote and offers flexible weekly hours ranging from 10 to 40. You will work with safety data, regulatory reporting and AI‑driven documentation tools.

Key responsibilities

• Author and review evaluation tasks for DSURs, PSURs/PBRERs and related safety data.
• Assess accuracy and adequacy of interval safety findings and signal evaluations.
• Ensure reports conform 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.
• 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

• Pharmacovigilance
• DSUR authoring
• PSUR/PBRER authoring
• ICH E2F compliance
• ICH E2C(R2) compliance
• GVP guideline application
• MedDRA coding
• Aggregate safety data analysis
• AI‑driven pharmacovigilance documentation tools