Senior Pharmacovigilance Specialist, Regulatory Intelligence and Submissions

ProPharma

. Manage and monitor expedited and non-expedited Individual Case Safety Report (ICSR) submissions and exchanges .

Posted 9/22/2026full-timeRemote • United States, Serbia, Croatia, North MacedoniaSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in pharmacovigilance reporting, including ICSR submissions, regulatory compliance, and the use of Oracle Argus Safety. Proficient in managing multiple priorities while ensuring quality and adherence to global regulations.

Highest-signal resume keywords

Pharmacovigilance Regulatory SubmissionsOracle Argus SafetyICSR SubmissionsXEVMPD KnowledgeRegulatory Compliance Activities

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Pharmacovigilance ReportingICSR ReconciliationE2B ExchangesPerformance Qualification TestingData Migration TestingQuality ControlCustom Report ValidationPeriodic Reporting RequirementsRegulatory SurveillanceSafety Database Management

Soft Skills

Attention to DetailOrganizational AbilitiesProblem-Solving SkillsVerbal CommunicationWritten Communication

Tools & Technologies

Microsoft OfficeOracle Argus SafetyRegulatory Intelligence Tools

Industry Keywords

Global Pharmacovigilance RegulationsCAPAHealth Authority SubmissionsSafety Partner ExchangesCross-Functional Collaboration

Tech Stack

Tools & technologies

Oracle

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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