Associate II – Patient Safety Solutions

Job not on LinkedIn

🕒 Yesterday

🇨🇦 Canada – Remote

💵 $67k - $82k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

👻 Ghost score 20%

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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

• Assist with Clinical Safety and/or Patient Safety Solutions operations for clinical-trial and post-approval products • Manage receipt and processing of spontaneous and clinical-trial adverse-event reports • Triage incoming cases and prioritize daily workflow • Perform medical adjudication for event validity, seriousness, expectedness, listedness, and causality using the WHO-UMC system • Enter safety data into adverse-event databases and tracking systems • Review adverse events for completeness, accuracy, appropriateness, and expedited-reporting requirements • Write patient narratives and code adverse events using MedDRA • Determine listedness against the appropriate product label • Identify missing clinically significant information and conduct follow-up • Process cases requiring expedited reporting to worldwide regulatory agencies within required timelines • Maintain understanding of SOPs, work instructions, guidance documents, and pharmacovigilance directives • Support root-cause analysis and CAPA development and implementation • Support or participate in audits and inspections • Build and maintain Patient Safety Solutions relationships across functional units • Perform other duties as needed

🎯 Requirements

• Associate’s degree OR RN + 2 years of Safety experience OR BS/BA + 1 year of Safety experience OR MS/MA + 1 year of Safety experience OR PharmD + 1 year of Safety experience • Relevant and equivalent experience may be considered in lieu of educational requirements • Minimum of two years of pharmacovigilance (PV) work experience in Canada / US • Advanced command of English, including speaking, writing, and reading • Proven expertise in processing U.S. post-approval cases • Proficiency with the Argus safety database • Strong typing ability • Familiarity with Microsoft Office Suite and Windows environment advantageous • Strong attention to detail and high degree of accuracy • Ability to work independently with minimal supervision • Good understanding of ICH guidelines and global regulatory requirements for adverse-event reporting • Willingness to work flexible or varied hours • Regular and consistent attendance • Ability to use in-house and off-the-shelf computer software • Ability to perform physical requirements including stationary work for 6–8 hours, repetitive hand movements, occasional travel, and lifting 15–20 lbs

🏖️ Benefits

• Full-time, home-based position • Flexible hours as needed to meet business needs • Compensation considers skills, prior relevant experience, degrees/certifications, internal equity, and market data • EEO & accommodations support

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