Pharmacovigilance Specialist, Submission

This is a fully remote position, open to applicants in Serbia.

📋 Description

• Comply with pharmacovigilance regulatory reporting protocols and guidelines.

• Daily oversight of scheduled expedited and non-expedited ICSR submissions and exchanges.

• Conduct monthly ICSR reconciliation reports in collaboration with PV clients and safety partners.

• Assist in the testing of gateway-to-gateway submissions to health authorities and ICSR exchanges.

• Create and resolve deviations related to submissions along with associated CAPAs.

• Produce Argus-based line listings and summary tabulations for Periodic Safety Reports.

• Support the generation and verification of customized periodic reports.

• Aid in the setup and validation of Periodic Safety Report requirements.

• Collaborate, develop, and maintain pharmacovigilance reporting services alongside the management team.

• Conduct PQ testing for multi-tenant Argus upgrades, patches, custom projects, and data migration imports.

• Implement process and documentation updates for territory-specific and custom E2B profiles.

⛳️ Requirements

• Post-secondary education or equivalent professional experience (life science degree preferred).

• C1 level proficiency in English.

• A minimum of 2 years of demonstrated experience in a similar role.

• Strong computer skills, especially with Microsoft Office Suite (Outlook, Word, Excel).

• Competent keyboarding abilities.

• Capacity to work both independently and as part of a multidisciplinary team.

🏝️ Benefits

• Support for remote work arrangements.

• Hybrid working model encouraged for new hires residing within a reasonable commute to an office, as agreed with the manager.

• Commitment to an equal opportunity workplace.

• Dedication to diversity, equity, and inclusion.