Senior Safety Associate

job summary:
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.

location: Cambridge, Massachusetts
job type: Contract
salary: $55 - 60 per hour
work hours: 9 to 5
education: Bachelors

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.

#LI-AH1

skills: Drug Safety, Veeva Vault Safety


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on randstadusa.com.


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.