Global Drug Safety & Pharmacovigilance Data Management Specialist

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 .

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 IC S R s 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. #J-18808-Ljbffr AllSTEM Connections