Pharmacovigilance Specialist, Submission

Job not on LinkedIn

🔥 2 minutes ago

🇷🇸 Serbia – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚫👨‍🎓 No degree required

👻 Ghost score 25%

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Lifelancer

51 - 200 employees

Founded 2020

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Pre Seed Round on 2022-03

Consulting • Healthcare • Logistics

Lifelancer is an AI-powered talent hiring platform that connects employers with skilled professionals in the Life Sciences, Pharmaceutical, and IT sectors. It enables individuals to create profiles showcasing their skills, get matched with high-paying international jobs or projects, and facilitates hiring and payroll for employers in multiple countries. The platform aims to streamline the hiring process with efficient AI sourcing and compliance support.

📋 Description

• 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

• 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

• 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

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