Pharmacovigilance Specialist, Submission

Lifelancer

. Adhere to pharmacovigilance regulatory reporting processes and instructions .

Posted 9/15/2026full-timeRemote • SerbiaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmacovigilance regulatory reporting processes, including ICSR submissions and safety partner exchanges, while ensuring compliance with health authority requirements. Proficient in generating and verifying reports using Argus and Microsoft Office Suite.

Highest-signal resume keywords

Pharmacovigilance Regulatory ReportingICSR Submission MonitoringArgus Database ManagementPeriodic Safety Report GenerationC1 Level English Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceICSR ReconciliationData Migration TestingPerformance Qualification TestingE2B Profile Updates

Soft Skills

Independent WorkCollaborative Teamwork

Tools & Technologies

ArgusMicrosoft Office Suite

Industry Keywords

Life Science DegreePharmacovigilance Reporting ServicesSafety Partner ExchangesSubmission-Related DeviationsCAPAs

About the role

Key responsibilities & impact

Adhere to pharmacovigilance regulatory reporting processes and instructions
Monitor scheduled expedited and non-expedited ICSR submissions and safety partner exchanges daily
Execute monthly ICSR reconciliation reports with PV clients and safety partners
Assist with testing gateway-to-gateway submissions to health authorities and ICSR exchanges
Assist with creation and closeout of submission-related deviations and associated CAPAs
Generate multi-tenant Argus-based line listings and summary tabulations for Periodic Safety Reports
Assist with generation and verification of custom periodic reporting reports
Assist with setup and verification of Periodic Safety Report requirements for health authorities
Assist the pharmacovigilance management team with coordinating, developing, and maintaining pharmacovigilance reporting services
Perform performance qualification testing for multi-tenant Argus upgrades, patches, and custom projects
Execute process and documentation updates for new territory-specific and custom E2B profiles
Perform Submissions-based PQ testing for data migration imports involving the multi-tenant Argus database

Requirements

What you’ll need

Post-secondary education or equivalent professional work experience (life science degree preferred)
C1 level of English
2 years of proven experience in a similar role
Proficient computer knowledge, specifically Microsoft Office Suite (Outlook, Word, Excel)
Computer keyboarding skills
Ability to work independently and collaboratively in a multidisciplinary team

Benefits

Comp & perks

Equal Opportunity Employer committed to diversity, equity, and inclusion
Safe and empowering workplace
Remote working support
Hybrid working encouraged for new hires within a reasonably short commute of an office, as agreed with the manager
Applications personally reviewed by a member of the recruitment team
Applicants receive an outcome to their application