Job Details

Pride Health is hiring for a Sr. Safety Associate in Cambridge, MA! (Hybrid, Contract)

Schedule: 40hrs/week (2 days in the office)

Contract: 1 year

Pay Rate: $55-60/hour

Key Responsibilities:

• Perform triage, intake, case entry, and QC of ICSRs from sponsored studies and other assigned cases
• Prepare case narratives, conduct MedDRA coding, draft follow-up queries, and generate event notifications for internal stakeholders
• Conduct retrospective quality reviews of processed cases
• Independently manage assigned case workloads, including weekends and holidays, to ensure timely delivery to internal stakeholders and completion of cases to support on-time regulatory reporting
• Review and resolve reconciliation discrepancies between clinical and safety databases in collaboration with Data Management
• Provide investigative details related to late regulatory reporting of clinical trial cases

Essential Skills and Qualifications:

• Knowledge of global and local safety regulations
• Experience with ICSR processing in safety databases such as ArisG, Argus, and Veeva
• Understanding of global safety reporting regulations and guidelines, including FDA, ICH, and EU pharmacovigilance requirements
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, and Outlook)
• Knowledge of medical and clinical practices with a strong understanding of medical concepts and terminology
• Education : Bachelor's degree in science or healthcare related field
• Experience : 4+ years experience in pharmacovigilance

Apply with Pride Health for this opportunity!

"Pride Global offers eligible employee's comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, auto, home insurance, pet insurance, and employee discounts with preferred vendors."
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