Temporary Meddra Coder Jobs (NOW HIRING)

AllSTEM Connections is seeking a Global Drug Safety & Pharmacovigilance Data Management Specialist to work hybrid/onsite in Plainsboro, NJ.

This is a six-month contract position. Possible extension/temp-to-hire.

Hourly rate is up to $55/hour.

M-F, 8AM - 5PM. Hybrid Work Schedule - onsite 3 days per week

SUMMARY:

A member of the Global Drug Safety & Pharmacovigilance Safety Operations team with the primary focus of case processing of safety information from clinical sources.

RESPONSIBILITIES:

• Perform safety case data entry in compliance with the data entry conventions and MedDRA/WHO DD coding conventions.
• Perform both real-time quality control of safety case data entry to ensure quality and compliance with the data entry conventions and MedDRA/WHO DD coding conventions.
• Support the management of the daily safety case workload as needed ensuring compliance with regulatory submissions and internal timelines including, but not limited to:
• Communicating to safety vendor as needed
• Monitor and triage email communications received in Safety Operation Mailboxes, as needed.
• Support the set-up and maintenance of individual study-specific activities.
• Perform reconciliation to ensure cases are received as per the relevant agreement.
• Participate or support Client initiatives and projects on Safety Operations behalf
• Other activities, as needed or as requested by supervisor.

QUALIFICATIONS:

• Drug Safety professional with minimum 3 years of experience within drug safety and PV inclusive of case quality control and regulatory submissions of ICSRs worldwide.
• Bachelor's/Master's degree in science.
• Knowledge of ICH E2B (R2) and (R3) specifications and entry guidance.
• Experience with clinical case processing, including MedDRA and WHO DD coding and narrative writing.
• Experience with safety database; Argus is a plus but not mandatory.
• Experience with EDC for clinical trial data collection is a plus but not mandatory.
• Excellent in detailed-oriented tasks.