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.

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, patches, and custom developments.
• →Support implementation and validation of new territory-specific and custom E2B profiles.
• →Participate in data migration testing and submissions-related system enhancements.
• →Contribute to projects aimed at improving efficiency, quality, and system performance.

xEVMPD Management

• →Prepare and maintain xEVMPD submissions, updates, removals, and new product entries within required timelines.
• →Conduct peer review and quality control of xEVMPD submissions.
• →Support bulk updates, QPPV changes, master file location updates, and developmental product registrations.

Education

• 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.

Experience

• 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 is 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.
• Comfortable working independently while collaborating effectively within cross-functional and global teams.
• Proficiency in Microsoft Office applications, including Outlook, Word, and Excel.