Product Safety Coordinator jobs in United States
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Zenith LifeScience · 3 hours ago

Product Safety Coordinator

positionUnited States
timeContract
remoteRemote
seniorityMid, Senior Level
date5+ years exp

Zenith LifeScience is seeking a Product Safety Coordinator to manage adverse event reports for their products. The role involves evaluating clinical trial reports, preparing cases, and ensuring compliance with regulatory deadlines while communicating with partners and affiliates.

Clinical TrialsConsultingLife SciencePharmaceuticalProduct Research
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H1B Sponsor Likelynote
Hiring Manager
Amita Chandidas
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Responsibilities

Receipt and triage of Adverse event reports for marketed and investigational products from all sources
Preliminary evaluation of clinical trial, spontaneous (post-marketing), and solicited reports of adverse events, including communication with partners and affiliates when necessary to verify completeness and accuracy
Case preparation - duplicate searches, initial data entry, and assignment of cases to Specialists
Particular emphasis is placed on determination of seriousness, expectedness, and validity
Prioritizes workload to ensure Company and Regulatory Authority deadlines are met
May include internal and external distribution of information to co-marketing partners, Company affiliate offices, and others as requested

Qualification

Data codingRetrievalMedical terminologyProduct Safety/PharmacovigilanceBachelor’s degreeMulti-taskingIndependenceAttention to detailCommunication skillsTeamwork

Required

Bachelor's degree required, preferably in a Scientific or Medical discipline
Around 5 to 7 years of experience in data coding and retrieval skills using database technology
Knowledge of Medical terminology
Precise attention to detail and ability to multi-task
Good communication skills, both written and verbal
Ability to work independently, and as part of a team

Preferred

Prior work experience in Product Safety/Pharmacovigilance

Company

Zenith LifeScience

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Zenith LifeScience is a consulting company that specializes in clinical trials, research, pharmacovigilance, and regulatory compliance.
location
South Plainfield, New Jersey, USA
people-size51-200 employees
web-link
https://zenithlifescience.com/

H1B Sponsorship

Zenith LifeScience has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (21)
2024 (10)
2023 (3)
2022 (14)
2021 (4)
2020 (4)

Funding

Current Stage
Growth Stage
Company data provided by crunchbase