Drug Safety Specialist jobs in United States
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SGS Consulting · 1 day ago

Drug Safety Specialist

positionCambridge, MA
timeContract
remoteHybrid
seniorityMid Level
money$58/hr - $62/hr
date4+ years exp

SGS Consulting is seeking a US Clinical Trial Consultant II to manage case processing and quality control of clinical trial ICSRs and postmarket case processing. The role involves triaging, intake, and quality checks of cases, as well as ensuring timely regulatory reporting and collaboration with data management.

ConsultingRecruitingStaffing Agency
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Growth Opportunities
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H1B Sponsor Likelynote
Hiring Manager
Shivam Goswamy
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Responsibilities

Triage, Intake, case entry and QC of ICSRs originating from Biogen sponsored studies or other assigned cases
Includes narrative writing, MedDRA coding, drafting of follow-up queries and event notifications to internal stakeholders
Perform retrospective quality checks on processed cases
Independently manage assigned cases, accounting for weekends and holidays, to deliver cases to internal stakeholders on time and ensure case completion allowing for on-time regulatory reporting
Review and resolution of reconciliation issues between the clinical and safety databases per in collaboration with Data Management
Provide investigation details into late regulatory reporting of CT cases

Qualification

ICSR processingGlobal safety regulationsSafety database systemsMedical terminologyMicrosoft SuiteWritten communicationVerbal communication

Required

Knowledge of Global and local safety regulations
Excellent written and verbal communication skills
Experience in ICSR processing in safety database systems such as ArisG, Argus and Veeva
Understanding of global safety reporting regulations and guidelines including the FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance
Strong computer skills within Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
Knowledge of medical and clinical practices and a strong understanding of medical concepts and terminology required
Bachelor's degree in science or healthcare related field
4+ years experience in pharmacovigilance

Company

SGS Consulting

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SGS Consulting is a client-centric organization that offers workplace and payroll solutions.
dateFounded in 1997
location
Princeton, New Jersey, USA
people-size1001-5000 employees
web-link
http://www.sgsconsulting.com

H1B Sponsorship

SGS Consulting 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
2022 (1)

Funding

Current Stage
Late Stage
Company data provided by crunchbase