Senior Pharmacovigilance Specialist, Regulatory Intelligence and Submissions

🔥 0 minutes ago

🌐 United States, Serbia, +2 more countries – Remote

🇺🇸 United States – Remote 🇷🇸 Serbia – Remote 🇭🇷 Croatia – Remote 🇲🇰 North Macedonia – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

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ProPharma

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 2001

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

💰 $8.6M Venture Round on 2020-10

Healthcare • Logistics • Manufacturing

ProPharma is a leading research consulting organization in the life sciences industry. The company specializes in providing custom solutions across the full product lifecycle, from early discovery to post-market monitoring. ProPharma's services include regulatory sciences, clinical research solutions, quality and compliance services, pharmacovigilance, medical information, and R&D technology. Known for its deep domain expertise, ProPharma assists clients in the pharmaceuticals, biotechnology, and medical device sectors with regulatory support, clinical development, and quality management. ProPharma's global team supports a wide range of therapeutic areas including oncology, cardiovascular, and rare diseases, among others, ensuring effective and efficient delivery of life-saving therapies.

📋 Description

• 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 investigation, documentation, and resolution of submission-related deviations and CAPAs • Generate Argus-based line listings and summary tabulations for periodic safety reports • Assist in creating, validating, and quality reviewing custom reports and reporting outputs • Support setup, verification, and maintenance of periodic reporting requirements across global markets • Coordinate periodic report submissions in compliance with local regulatory requirements • Support pharmacovigilance reporting services and operational excellence • Research, collect, and maintain global pharmacovigilance reporting requirements • Conduct monthly regulatory surveillance and impact assessments • Support regulatory intelligence tools, mailboxes, tickets, queries, and ad hoc projects • Provide guidance on evolving pharmacovigilance regulations and reporting obligations • Perform Performance Qualification (PQ) testing for Argus upgrades, patches, and custom developments • Support implementation and validation of territory-specific and custom E2B profiles • Participate in data migration testing and submissions-related system enhancements • Contribute to projects improving efficiency, quality, and system performance • Prepare and maintain xEVMPD submissions, updates, removals, and new product entries • Conduct peer review and quality control of xEVMPD submissions • Support bulk updates, QPPV changes, master file location updates, and developmental product registrations

🎯 Requirements

• High school diploma required • Post-secondary education in a life sciences discipline is preferred • Equivalent professional experience in pharmacovigilance regulatory submissions or regulatory intelligence will also be considered • Minimum of 3 years' experience working with pharmacovigilance safety databases • Experience with safety reporting, ICSR submissions, E2B exchanges, and regulatory compliance activities preferred • Experience with Oracle Argus Safety or similar safety databases highly desirable • Knowledge of xEVMPD and global pharmacovigilance regulations is an advantage • Strong attention to detail and commitment to quality • Excellent verbal and written communication skills • Strong organizational and problem-solving abilities • Ability to manage multiple priorities and adapt to changing business needs • Ability to work independently while collaborating effectively within cross-functional and global teams • Proficiency in Microsoft Office applications, including Outlook, Word, and Excel

🏖️ Benefits

• Work with a global team of pharmacovigilance and regulatory experts • Gain exposure to international safety reporting requirements and health authority interactions • Contribute to meaningful projects supporting patient safety and regulatory compliance worldwide • Develop expertise across submissions, regulatory intelligence, testing, and PV systems • Hybrid working encouraged for new hires based within a reasonably short commute of an office, as agreed with the manager • Equal Opportunity Employer workplace committed to diversity, equity, and inclusion