Workflow Manager, Pharmacovigilance Operations – Specialist II

Job not on LinkedIn

🔥 0 minutes ago

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

💵 $80k - $105k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

⚙️ Operations

🚫👨‍🎓 No degree required

👻 Ghost score 20%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Lifelancer

WebsiteLinkedInAll Job Openings

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

• Manage the receipt and processing of adverse event reports from spontaneous sources and clinical trials • Enter safety data into the safety database and review adverse events • Write patient narratives with coding • Follow up on missing information • Assess cases against the appropriate product label for marketed products, if applicable • Submit expedited Serious Adverse Event reports to clients, regulatory authorities, ethics committees, investigators, third-party vendors, partners, and Fortrea project personnel when required • Prioritize cases requiring expedited reporting and ensure submission within regulatory and study-specific timelines • Work with Data Management or clients on reconciliation of safety databases, when appropriate • Support audit or inspection preparations • Coordinate workflow activities across safety operations • Monitor case progression and compliance metrics • Identify and resolve workflow delays • Ensure efficient utilization of resources and high-quality service delivery • Provide operational support to client project teams and standalone programs • Comply with applicable pharmacovigilance regulations, company procedures, quality standards, and health and safety requirements • Perform other duties as assigned by management

🎯 Requirements

• Non-degree + 2-3 years of Safety experience or 5 years of relevant experience • Associate degree + 2-3 years of Safety experience or 4 years of relevant experience • BS/BA + 2 years of safety experience or 3-4 years of relevant experience • MS/MA + 2 years of safety experience or 2-3 years of relevant experience • PharmD + 2 years of safety experience or 2-3 years relevant experience • Minimum of 2 years of pharmacovigilance (PV) work experience • Advanced command of English language, including speaking, writing, and reading • Strong knowledge of safety databases (e.g., Argus), workflow tracking systems, and case management tools • Strong organizational and project management skills • Analytical mindset with problem-solving capabilities • Good understanding of ICH guidelines and global regulatory requirements for the reporting of adverse events for both marketed and investigational products • Candidates must be legally authorized to work in the country in which they reside (United States or Canada) • Fortrea is unable to provide current or future employment sponsorship for this position • Regular and consistent attendance • Ability to access and use a variety of computer software developed both in-house and off-the-shelf • Ability to perform the stated physical requirements, including occasional crouching, stooping, bending, twisting, and light to moderate lifting/carrying of 15-20 lbs • Bachelor’s degree in life sciences, pharmacy, or a related field preferred; equivalent combination of education and relevant experience will also be considered • Experience supporting U.S. and/or Canadian regulatory environments is preferred • Preferred experience: 4-5 years in pharmacovigilance or drug safety operations

🏖️ Benefits

• Remote-based office environment • Occasional travel both domestic and international • All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data