Submission Analyst

Overview

Member of the Safety Submissions team within Global Pharmacovigilance, responsible for electronic distribution and submission of individual case safety reports (ICSRs), including maintaining and setting up electronic submission rules in the pharmacovigilance database.

What you'll do

• Create, review, and issue regulatory safety reports, including Individual Case Safety Reports (ICSRs), in compliance with global pharmacovigilance requirements.
• Execute and monitor electronic submissions of ICSRs to regulatory authorities, affiliates, and business partners, ensuring timely and accurate reporting.
• Participate in peer reviews of safety submissions to maintain data quality and regulatory compliance.
• Maintain and support electronic reporting configurations, submission rules, and reportability settings within the pharmacovigilance database.
• Support the implementation and maintenance of electronic reporting standards, including ICH E2B and HL7 data exchange requirements.
• Troubleshoot electronic submission issues and E2B rejections, working with Safety Operations and stakeholders to ensure successful report transmission.
• Collaborate with global and regional pharmacovigilance teams to facilitate electronic regulatory submissions and distribution of safety reports.
• Partner with Pharmacovigilance Technology teams on database maintenance, reporting processes, and system enhancements.
• Work closely with Safety Operations, Regulatory Affairs, Quality, IT, Legal, and other cross-functional teams to support efficient and compliant adverse event reporting.
• Identify, assess, and escalate potential safety, quality, or compliance risks in a timely manner.
• Contribute to process improvements, special projects, and other pharmacovigilance activities that support business and regulatory objectives.
• Ensure all assigned activities are performed in accordance with applicable regulations, company procedures, and quality standards.

What you'll need

• Solid knowledge of pharmacovigilance terminology, specifically International Council for Harmonisation (ICH E2B), and system data entry conventions.
• Capacity to analyze and resolve problems with analytical and problem-solving skills.
• Strong organizational skills with strong attention to detail.
• Excellent written and oral communication skills.
• Operates effectively in a team environment.
• Global Safety Database knowledge.
• Solid technical system skills (e.g. word processing, spreadsheet, databases, and markup languages).
• Knowledge of medical terminology.
• Bachelor's degree in computer science, life sciences or equivalent.

Nice to have

• One year of previous experience in Safety Submissions or other area of pharmacovigilance, regulatory affairs and/or clinical research.
• Additional job experience in quality assurance, data management, or IT is relevant.