Senior Pharmacovigilance Specialist, Regulatory Intelligence and Submissions

This is a fully remote position, open to applicants in United States, +3 more countries.

📋 Description

• Oversee and track expedited and non-expedited Individual Case Safety Report (ICSR) submissions and exchanges.

• Ensure adherence to global pharmacovigilance reporting standards and internal protocols.

• Conduct monthly reconciliation activities for ICSRs with clients and safety partners.

• Assist with gateway-to-gateway testing for submissions to health authorities and exchanges with safety partners.

• Aid in the investigation, documentation, and resolution of issues related to submissions and CAPAs.

• Produce Argus-based line listings and summary tabulations for periodic safety reports.

• Help in the creation, validation, and quality review of custom reports and reporting outputs.

• Support the establishment, verification, and upkeep of periodic reporting needs across global markets.

• Coordinate periodic report submissions in alignment with local regulatory standards.

• Enhance pharmacovigilance reporting services and operational excellence.

• Research, gather, and maintain global pharmacovigilance reporting requirements.

• Perform monthly regulatory surveillance and impact assessments.

• Assist with regulatory intelligence tools, mailboxes, tickets, queries, and ad hoc projects.

• Provide insights on evolving pharmacovigilance regulations and reporting responsibilities.

• Conduct Performance Qualification (PQ) testing for Argus upgrades, patches, and custom developments.

• Support the implementation and validation of territory-specific and custom E2B profiles.

• Engage in data migration testing and enhancements related to submissions systems.

• Contribute to initiatives aimed at improving efficiency, quality, and system performance.

• Prepare and maintain xEVMPD submissions, updates, removals, and new product entries.

• Conduct peer reviews and ensure quality control of xEVMPD submissions.

• Assist with bulk updates, QPPV changes, master file location updates, and registrations for developmental products.

⛳️ Requirements

• A high school diploma is mandatory.

• A post-secondary qualification in a life sciences field is preferred.

• Relevant professional experience in pharmacovigilance regulatory submissions or regulatory intelligence will also be taken into account.

• A minimum of 3 years of experience with pharmacovigilance safety databases is required.

• Preference will be given to candidates with experience in safety reporting, ICSR submissions, E2B exchanges, and regulatory compliance activities.

• Experience with Oracle Argus Safety or similar safety databases is highly desirable.

• Familiarity with xEVMPD and global pharmacovigilance regulations is advantageous.

• A strong attention to detail and commitment to quality is essential.

• Excellent verbal and written communication skills are required.

• Strong organizational and problem-solving skills are necessary.

• Capacity to manage multiple priorities and adapt to shifting business needs is important.

• Ability to work independently while effectively collaborating within cross-functional and global teams is essential.

• Proficiency in Microsoft Office applications, including Outlook, Word, and Excel, is required.

🏝️ Benefits

• Collaborate with a global team of pharmacovigilance and regulatory specialists.

• Gain insights into international safety reporting requirements and interactions with health authorities.

• Contribute to impactful projects that support patient safety and regulatory compliance on a global scale.

• Develop expertise across submissions, regulatory intelligence, testing, and pharmacovigilance systems.

• Hybrid working arrangements are encouraged for new hires living within a reasonable commuting distance from an office, as agreed upon with the manager.

• Work in an Equal Opportunity Employer environment committed to diversity, equity, and inclusion.