Drug Safety Specialist

Role Overview

This position is a contract role for a Pharmacovigilance Specialist focused on drug safety evaluations. The job is remote and offers hourly compensation between $70 and $80, with a flexible weekly commitment of 10 to 40 hours.

Primary Responsibilities

• Compose and critically assess evaluation tasks for documents such as Development Safety Update Reports (DSURs) and Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports (PSURs/PBRERs) along with supporting safety data.
• Validate the precision and sufficiency of safety interval outcomes and signal detection assessments.
• Ensure that reporting templates and structures comply with ICH E2F and ICH E2C standards.
• Verify consistency of numerical data and case counts between different sections of reports and data repositories.
• Analyze safety conclusions considering emerging data or events.
• Provide detailed feedback aimed at enhancing AI-powered pharmacovigilance documentation tools.

Candidate Requirements

• Extensive relevant background in pharmacovigilance or drug safety fields.
• Demonstrated capability in authoring or reviewing DSURs and PSURs/PBRERs.
• Proficient knowledge of International Council for Harmonisation (ICH) guidelines, specifically E2F and E2C(R2), and the Good Pharmacovigilance Practices (GVP).
• Practical experience with Medical Dictionary for Regulatory Activities (MedDRA) coding and aggregated safety data analysis.
• Possession of an advanced degree in life sciences, pharmacy, nursing, or medicine is desirable.

Additional Information

• Application includes a streamlined process with resume evaluation and interview phases.
• Compensation: $70-$80 per hour.
• Work commitment ranges from 10 to 40 hours weekly.