Senior Safety Associate

About the role

Join a top-tier global pharma leader driving innovation in patient safety. As a Senior Safety Associate III, you will serve as a vital bridge between drug safety operations and systems functionality. This position plays a critical role in optimizing database functions, driving global regulatory compliance, and delivering high-quality case safety processing workflows.

Responsibilities

• Execute UAT scripts and conduct informal testing to validate global safety database behavior prior to release.
• Draft, update, and maintain Data Entry Guidelines (DEGs), quick reference guides, and operational documentation.
• Partner with IT and the TCOE team by supplying realistic business scenarios and reviewing test materials.
• Translate database functionality and global safety requirements into clear step-by-step instructions for end users.
• Investigate complex user inquiries, data migration issues, and safety database configuration challenges.
• Review vendor case processing materials to ensure operational alignment and regulatory accuracy.

Qualifications

Required

• Strong Pharmacovigilance background with deep knowledge of ICSR processes and global regulations (GVP, ICH).
• Hands-on experience executing UAT scripts and testing safety database systems.
• Direct experience writing and maintaining DEGs, SOPs, Work Instructions, or related procedural documents.
• Experience authoring, reviewing, and delivering PV training content.
• Advanced proficiency in Microsoft Office applications with exceptional organizational skill and detail orientation.
• Strong communication skills to collaborate effectively with IT teams, internal groups, and vendor partners.

Preferred

• Direct experience with Veeva systems (Veeva Safety, Veeva Quality).
• Background writing test scenarios and supporting software release cycles in pharma or biotech.
• Experience supporting Business Process Owners (BPO) during safety system implementations.

Skills

• Drug Safety
• Veeva Vault Safety

Location: Cambridge, Massachusetts
Job type: Contract
Pay: $55 - 60 per hour
Work hours: 9 to 5
Education: Bachelors