Regulatory Submission Specialist

Position/Job Role:

Location:

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Job Overview

We are seeking a highly skilled and detail-oriented Submission Expert specializing in Individual Case Safety Reports (ICSR) and aggregate report submissions to join our Pharmacovigilance team. This role is critical in ensuring the timely and accurate submission of ICSRs and aggregate reports to regulatory authorities in compliance with global pharmacovigilance regulations and guidelines.

Functional Responsibilities:

• Manage timely submission of global ICSRs to health authorities, license partners, and CROs.

• Prepare local paper submissions to the US FDA, following client-specific processes.

• Proficient in ICSR submissions including MedWatch, CIOMS I, E2B(R2), and E2B(R3) for approved

and investigational drugs, biologics, and medical devices.

• Support safety reporting for aggregate reports/periodic safety reports and related activities.

• Perform and oversee aggregate report submissions to regulatory authorities (RAs), ethics

committees (ECs), institutional review boards (IRBs), and investigators.

• Track and archive aggregate report submissions and correspondence.

• Support EudraVigilance registration and account maintenance, as well as registration to other

regulatory portals for submissions.

• Generate, review, and transmit reports to global health authorities (e.g., FDA, EMA, MHRA,

Health Canada).

• Stays updated on regulatory requirements through regulatory intelligence to ensure compliance

with submission rules across global health authorities

• Maintaining the submission requirements tracker with country-level safety reporting

requirements.

• Ensure timely report submissions to global partners in line with PVAs.

• Participate in gateway-to-gateway ICSR submission testing with health authorities and partners.

• Prepare ICSR submission packages per regulatory requirements.

• Monitor global submission mailboxes to address high-priority queries from authorities and

partners.

• Manage daily submission worklists to meet deadlines across all destinations.

• Monitor the safety database for failed transmissions and resolve them promptly.

• Coordinate with case processors and medical reviewers for timely case corrections.

• Investigate late submissions, identify root causes, and implement corrective and preventive

actions.

• Provide training and mentorship to new submission team members.

• Maintain accurate and up-to-date reporting rules in the safety database.

• Stay informed on global PV regulations and ensure compliance in all submission activities.

• Review PV Agreements and Safety Management Plans for updates impacting reporting

configuration.

Other Details:

• Maintain comprehensive documentation of submission activities for audit and inspection

readiness.

Education:

Skills and personal attributes:

• Fluency in spoken and written English; Good Communication skills.

• Ability to work in a team with ability to prioritize the assigned work.

• Proficiency in MS Office suite (Word/Excel/ PowerPoint).

Minimum Work Experience:

Must have a minimum of 3- 4 years of submission experience and strong knowledge of regulatory

guidelines/requirements