Senior Pharmacovigilance Specialist, Regulatory Intelligence and Submissions

Location: Belgrade, Serbia. Remote working is supported, with hybrid work encouraged for new hires within a reasonably short commute of a hirify.global office.

Company

hirify.global provides consulting solutions across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology for biotech, medical device, and pharmaceutical organizations.

What you will do

• Manage and monitor expedited and non-expedited ICSR submissions and exchanges, ensuring compliance with global pharmacovigilance requirements.
• Conduct monthly ICSR reconciliation with clients and safety partners, and support gateway-to-gateway testing.
• Generate Argus-based line listings and summary tabulations for periodic safety reports and coordinate submissions across global markets.
• Research regulatory requirements, perform monthly surveillance and impact assessments, and provide guidance on evolving PV obligations.
• Perform PQ testing for Argus upgrades, patches, custom developments, data migrations, and E2B profile implementations.
• Prepare, maintain, peer-review, and quality-control xEVMPD submissions, updates, removals, product entries, and related master data changes.

Requirements

• At least 3 years of experience working with pharmacovigilance safety databases.
• Experience with safety reporting, ICSR submissions, E2B exchanges, and regulatory compliance activities.
• High school diploma required; post-secondary education in life sciences is preferred, or equivalent professional experience.
• Strong attention to detail, quality focus, communication, organization, and problem-solving skills.
• Ability to manage multiple priorities, work independently, and collaborate with cross-functional global teams.
• Proficiency in Microsoft Office applications, including Outlook, Word, and Excel.

Nice to have

• Experience with Oracle Argus Safety or a similar safety database.
• Knowledge of xEVMPD and global pharmacovigilance regulations.
• Post-secondary education in a life sciences discipline.

Culture & Benefits

• Work with a global team of pharmacovigilance and regulatory experts.
• Gain exposure to international safety reporting requirements and health authority interactions.
• Contribute to projects supporting patient safety and regulatory compliance worldwide.
• Develop expertise across submissions, regulatory intelligence, testing, and PV systems.
• Remote working is supported, with in-person collaboration and hybrid work encouraged where practical.
• Inclusive workplace focused on diversity, equity, inclusion, collaboration, and innovation.

Hiring process

• Applications are personally reviewed by a member of the recruitment team.
• Applicants receive an outcome regarding their application.