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

About the role

We are looking for an experienced Clinical Safety Specialist to author and review pharmacovigilance evaluation tasks on a remote contract basis. The role focuses on ensuring safety reporting complies with international guidelines and supports AI‑driven documentation tools.

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 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.
• Provide structured feedback for AI‑driven pharmacovigilance documentation tools.

Required profile

• Strong relevant experience in pharmacovigilance or drug safety.
• Advanced degree in life sciences, pharmacy, nursing or medicine (preferred).

Required skills

• Proficiency authoring or reviewing DSURs and PSURs/PBRERs.
• Working fluency with ICH E2F, ICH E2C(R2) and GVP guidelines.
• Hands‑on experience with MedDRA coding and aggregate safety data analysis.