Senior Safety Associate

job summary:
Take direct ownership of ICSR quality oversight, PV vendor performance, and safety database testing for Global Case Management. This role handles the hands-on mechanics of pharmacovigilance operations-running UAT, analyzing late case trends, and updating critical SOPs and training materials to keep global safety operations compliant and inspection-ready.

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

responsibilities:

• Supports workflow management-related tasks
• Supports ICSR quality oversight tasks such as performing quality review, analyzing quality trends and effectiveness of actions implemented by vendor
• Support review and assessment of late case investigations
• Support monthly compilation of safety case processing vendor performance KPIs
• Supports review and updates in controlled documents
• Supports distribution of external controlled documents
• Support monthly mailbox monitoring
• Supports Global Safety Database testing, including UAT testing
• Supports audit/inspection readiness activities
• Supports investigations of potential Global Safety Database issues
• Supports Data Migration related tasks
• Support other tasks as assigned by manager

 
qualifications:
REQUIRED:

• Must have advanced proficiency in Microsoft Office applications
• Must be able to multi-task and produce quality work within required timelines, with minimal supervision
• Must be able to work both independently and in a team setting
• Must have experience with PV case processing, quality review, oversight
• Must have experience with SOP, WI and other procedural documents authoring/updates
• Must have experience with PV training authoring, review, delivery

PREFERRED:

• Experience working with Veeva systems (e.g., Veeva Safety, Veeva Quality)
• Experience performing Global Safety Database testing, including UAT
• Exceptional organizational skills and attention to detail
• Excellent communication skills (written and verbal)
• Ability to work collaboratively in a team environment
• Ability to collaborate in multiple projects at a time

#LI-KH1

skills: Case Processing, Individual Case Safety Report (ICSR)


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.