Pharmacovigilance Specialist, Submission

Location: Belgrade, Serbia. Remote work is supported, with hybrid work encouraged for employees within a short commute of an office.

Company

hirify.global provides consulting and operational expertise 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

• Monitor scheduled expedited and non-expedited individual case safety report submissions and safety partner exchanges in the multi-tenant Argus database.
• Execute monthly ICSR reconciliation reports with clients and safety partners.
• Support gateway-to-gateway submission testing, health authority reporting, and submissions to new territories or product types.
• Generate Argus-based line listings and summary tabulations for Periodic Safety Reports and support report verification.
• Support the setup and verification of Periodic Safety Report requirements and help manage submission-related deviations and CAPAs.
• Perform qualification testing for Argus upgrades, patches, custom projects, E2B profiles, and data migration imports.

Requirements

• At least 2 years of experience in a similar pharmacovigilance or submissions role.
• Post-secondary education or equivalent professional experience; a life science degree is preferred.
• English at C1 level is required.
• Proficiency with Microsoft Office, including Outlook, Word, and Excel, plus strong keyboarding skills.
• Ability to work independently and collaboratively in a multidisciplinary team.

Culture & Benefits

• Remote work is supported, with hybrid collaboration available for employees near an office.
• Inclusive workplace focused on diversity, equity, inclusion, and equal opportunity.
• Applications are reviewed personally by the recruitment team without AI screening tools.
• Every applicant receives an outcome regarding their application.