Pharmacovigilance Specialist, Submission

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

📋 Description

• Comply with pharmacovigilance regulatory reporting procedures and guidelines.

• Daily monitoring of scheduled expedited and non-expedited ICSR submissions as well as safety partner communications.

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

• Support testing of gateway-to-gateway submissions to health authorities and ICSR exchanges.

• Aid in the creation and closure of submission-related deviations and related CAPAs.

• Generate Argus-based line listings and summary tabulations for Periodic Safety Reports across multiple tenants.

• Assist in the generation and verification of customized periodic reporting reports.

• Help set up and verify Periodic Safety Report requirements for health authorities.

• Collaborate with the pharmacovigilance management team in coordinating, developing, and maintaining pharmacovigilance reporting services.

• Conduct performance qualification testing for multi-tenant Argus upgrades, patches, and specialized projects.

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

• Execute submissions-based PQ testing for data migration imports related to the multi-tenant Argus database.

⛳️ Requirements

• Post-secondary education or equivalent professional experience (preferably in life sciences).

• English language proficiency at C1 level.

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

• Proficient in computer applications, particularly the Microsoft Office Suite (Outlook, Word, Excel).

• Competent keyboarding skills.

• Capable of working both independently and collaboratively within a multidisciplinary team.

🏝️ Benefits

• Equal Opportunity Employer dedicated to diversity, equity, and inclusion.

• A safe and empowering work environment.

• Support for remote work arrangements.

• Hybrid working model encouraged for new hires residing within a reasonable commuting distance from an office, as agreed upon with the manager.

• Applications are personally reviewed by a member of the recruitment team.

• Applicants receive feedback regarding the outcome of their application.