GPV Submission Specialist I

GPV Submission Specialist I 12 month contract On-site in Princeton, NJ ResponsibilitiesManage daily operational activities of the Global Submissions team within case processing. Manage timely submission of global ICSRs to Health Authorities, License Partners, and CROs. Monitor the global submissions mailbox and address high priority emails and queries related to ICSR submissions. Prepare local paper submissions to the US FDA in accordance with internal processes. Complete daily worklists to ensure submissions are sent to all applicable reporting destinations. Generate, review, and transmit reports to global Health Authorities including FDA, European Agencies, Health Canada, and other regulatory agencies. Submit reports to global partners within defined timelines per Pharmacovigilance Agreements. Submit expedited ICSR reports to Ethics Committees and Investigators according to country-specific requirements. Monitor the safety database for failed transmissions and resolve issues in a timely manner. Prepare safety ICSR submission packages for Health Authorities as required. Follow up with Case Processing teams and Medical Reviewers to obtain case corrections for timely report submissions. Provide training and support to new members of the submissions team. Collaborate with Regulatory Intelligence and Safety Data Management teams to maintain accurate reporting rules within the safety database. Review Pharmacovigilance Agreements and Safety Management Plans to identify new requirements or updates for reporting rule configurations. Configure clinical studies within the safety database and establish reporting rules based on clinical trial protocols and regulatory requirements. Support local safety managers with ICSR submission-related activities as the submissions subject matter expert. Identify root causes for late ICSR submissions and provide corrective and preventive actions to Compliance and Business Management teams. Investigate, analyze, and respond to Health Authority queries in a timely manner. Monitor and manage weekly ICSR submission reconciliations with local safety managers. Assist the Global Pharmacovigilance team with projects focused on enhancing system performance. QualificationsBachelor of Science or related healthcare degree preferred; equivalent relevant experience may be considered. 1 to 3 years of submissions experience. Experience within the pharmaceutical, biotechnology, or CRO industry. Demonstrated proficiency with safety database functionality. Drug safety experience including processing AE/SAE reports, narrative generation, query management, safety databases, and regulatory submissions. Knowledge of global safety reporting regulations and guidelines including FDA, ICH, and EU Pharmacovigilance requirements. Experience with expedited ICSR submissions to Health Authorities, Ethics Committees, and Investigators. Knowledge of medical device submissions. Experience with ARGUS Safety Database. Prior experience in case processing. Strong technical skills with the ability to interpret and integrate scientific data from multiple sources. Strong written and verbal communication skills. Proficiency with Microsoft Office programs including Word, Excel, PowerPoint, and Outlook. Ability to apply organizational policies and regulatory procedures across various situations. Ability to work under pressure and meet tight timelines. Ability to work effectively in a matrix environment. Strong attention to detail and problem-solving skills. Ability to work effectively in a team environment. Ability to manage multiple projects simultaneously.