Senior Pharmacovigilance Specialist, Regulatory Intelligence and Submissions

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. Are you passionate about pharmacovigilance compliance, regulatory intelligence, and global safety reporting? Join our team as a Senior Pharmacovigilance (PV) Specialist, Regulatory Intelligence & Submissions, where you will play a critical role in ensuring timely and compliant safety submissions, supporting regulatory intelligence activities, and contributing to the continuous improvement of pharmacovigilance systems and processes. This is an exciting opportunity for a detail-oriented PV professional who enjoys working in a fast-paced, global environment and has hands-on experience with safety databases, regulatory reporting requirements, and health authority submissions. What You'll Do Adverse Event Submission & Compliance Manage and monitor expedited and non-expedited Individual Case Safety Report (ICSR) submissions and exchanges. Ensure compliance with global pharmacovigilance reporting requirements and internal procedures. Conduct monthly ICSR reconciliation activities with clients and safety partners. Support gateway-to-gateway testing for health authority submissions and safety partner exchanges. Assist with the investigation, documentation, and resolution of submission-related deviations and CAPAs. Periodic Safety Reporting Generate Argus-based line listings and summary tabulations for periodic safety reports. Assist in the creation, validation, and quality review of custom reports and reporting outputs. Support the setup, verification, and maintenance of periodic reporting requirements across global markets. Coordinate periodic report submissions in compliance with local regulatory requirements. Partner with the pharmacovigilance leadership team to support reporting services and operational excellence. Regulatory Intelligence Research, collect, and maintain global pharmacovigilance reporting requirements for pharmaceutical, biologic, and medical device products. Conduct monthly regulatory surveillance and impact assessments. Support regulatory intelligence tools, mailboxes, tickets, queries, and ad hoc projects. Provide guidance and support on evolving PV regulations and reporting obligations. Systems, Testing & Process Improvement Perform Performance Qualification (PQ) testing for Argus upgrades,…