DSA/SDSA- ICSR

About Navitas Life Sciences:

Navitas Life Sciences is a technology-backed global clinical research organization, headquartered in Princeton, NJ, with over 1000 employees and spread across 5 countries.

At Navitas Life Sciences, we are committed to accelerate time to market for life-saving therapies. We are a technology driven CRO with end-to-end and point services and solutions for drug development and beyond. We provide outsourced data science, regulatory & safety, and full-service CRO services to large and mid-sized biopharmaceutical clients. Navitas Clinical Research provides full service CRO offerings to global biopharma companies. Navitas Data Sciences is our global clinical data functional service provider.

Our functional service expertise optimizes the clinical trial process, drives cost efficiencies for our clients, and ensures adherence to regulatory compliance requirements. Navitas Life Sciences industry-focused consulting services enable our clients to build innovative and sustainable processes, systems & organizations. For over 20 years our industry-leading networks bring together top companies worldwide and shape the future of the industry.

Navitas Life Sciences is proud to be an HIG Portfolio company.

Key Skills

Education:

Responsibilities & functions: Individual Case Safety Report

• Responsible for Data entry services
• Responsible for data entry of individual case safety reports (all case report types) into the safety database. Review and evaluate AE case information to determine required action based on and following internal policies and procedures.
• Process all cases to meet timelines as per prioritisation with defined quality and productivity in order to meet the project SLAs/KPIs.
• Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD)
• Responsible for writing and /or checking for correctness and completeness of the medically relevant safety narrative in chronological order.
• Responsible for checking the completeness and accuracy of the data entered in the various fields.
• Perform self-quality check before routing the case to the next workflow.
• Source document preparation and archival will be done as required.
• Performing necessary changes in the demoted/back routed cases from Quality reviewer/ Medical reviewer.
• Addressing case corrections for any internal/external findings post case locking.
• Generate follow up queries where necessary.
• Maintain Knowledge of global health authority regulations and requirements
• Support the team with other additional tasks as needed.
• Reviewing the QR feedback received and if necessary, ensure that the feedback comments were addressed.
• Co-ordinate with other workflows as required.
• Support leads/manager on operational activities as needed.