Sr Safety Associate, Case Management

job summary:
Responsible for case processing and/or QC of clinical trial ICSRs and post-market case processing from sanctioned countries.

location: Cambridge, Massachusetts
job type: Contract
salary: $55.00 - 58.72 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Triage, Intake, case entry and QC of ICSRs originating from sponsored studies or other assigned cases
• Includes narrative writing, MedDRA coding, drafting of follow-up queries and event notifications to internal stakeholders
• Perform retrospective quality checks on processed cases
• Independently manage assigned cases, accounting for weekends and holidays, to deliver cases to internal stakeholders on time and ensure case completion allowing for on-time regulatory reporting
• Review and resolution of reconciliation issues between the clinical and safety databases per in collaboration with Data Management
• Provide investigation details into late regulatory reporting of CT cases

qualifications:

• Knowledge of Global and local safety regulations
• Excellent written and verbal communication skills
• Experience in ICSR processing in safety database systems such as ArisG, Argus and Veeva
• Understanding of global safety reporting regulations and guidelines including the FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance
• Strong computer skills within Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
• Knowledge of medical and clinical practices and a strong understanding of medical concepts and terminology required
• Bachelor's degree in science or healthcare related field
• 4+ years experience in pharmacovigilance

skills: Pharmacovigilance, 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 [email protected].


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.