Submission Specialist

Job Overview

Responsible for the submission of Individual Case Safety Reports (ICSRs) following Sponsor standard operating procedures, internal business practices, and regulatory guidance documents, to ensure compliance with worldwide safety and Pharmacovigilance regulations.

Principle Responsibilities

• Responsible for reporting of ICSRs arising from post marketing and Interventional Clinical trial sources to Regulatory Authorities.
• Responsible for distributing ICSRs to Business Partners/License Partners per applicable Pharmacovigilance Agreements.
• Responsible for various formats of ICSR reporting that are submitted, such as xml, CIOMs, MedWatch format and E2B gateway reporting and transmission.
• Responsible for portal submissions, courier, and manual email submissions and attachments like CIOMS, MEDWATCH.
• Responsible for ICSR regulatory submissions for device reports and vaccines, as applicable.
• Responsible for monitoring submission workflows to ensure regulatory reporting within applicable due dates.
• Monitors and tracks E2b acknowledgements.
• Responsible for supporting investigation into compliance investigations.
• Responsible for late case tracking and preparation of submission metrics.
•  Performs the quality checks as applicable for “no submits” and cases submitted.
• Monitor and facilitate resolution for ICSR failed distributions and submissions.
• Provides support for other activities such as daily report review,  monitoring group mailbox, ad hoc data analyses.
• Identifies and communicates concerns and issues which may require raising tickets with Support Desk.
• May be requested to attend audits or inspections.

Required Skills/Abilities

• Intermediate Information Technology Skills
• Data entry experience desired
• Accountability for delivery of results
• Decision making skills.
• Problem solving skills.
• Proactive approach/uses own initiative.
• Manages own work, able to prioritize, plan and organize work assignments and work under strict timelines.
• Ability to follow guidelines, working practices etc. Experience of working with SOP/WI preferred
• Quality oriented, with attention to detail/accuracy
• Flexibility/Adaptability

Required Years of Experience

• 1-3 years of experience

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