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Clinical Trial Consultant 2

TalentBurst, an Inc 5000 company

Role overview

Qualifications

  • 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

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

Key facts

Hard skills

Other skills

  • Non-Verbal Communication
  • Microsoft Office

About the company

TalentBurst, an Inc 5000 company logo

TalentBurst, an Inc 5000 company

Staffing & Recruiting

Founded in 2002, TalentBurst is a certified MBE firm that provides award winning solutions globally including: IT/Eng, Prof, & F&A Staffing Life Sciences & Clinical Staffing SLED (State, Local, Education) Staffing High Hazard & Global Payroll 1099/IC Validation & Compliance Recognitions & awards include: 2023 Top Workplaces Best Place to Work 2023 Top Workplaces Culture Excellence 2023 World Staffing Summit Top 100 Staffing Firms to Work For 2023, 2022 SIA Diverse Owned Staffing Firms 2021 BBJ #1 Largest MBE Enterprise in MA 2020-2021 BBJ Fast50 2020 SIA Large Life Sciences Staffing Firms 10 time BBJ Pacesetter & INC 500/5000 5 time SIA-fastest growing GNEMSDC Supplier of Year Category 4 2019-2020 AgileOne Diverse Supplier of the Year 2021 AgileOne Gold Supplier 2017 Allegis Global Solutions Strategic Partner 2018-2023 Allegis Global Solutions Diversity Partner of the Year 2020 Coupa Advantage and Link Silver Partner Magnit Global Supplier Excellence 2023 PRO Unlimited Silver, Gold, & Platinum Supplier 2012-2020 PRO Unlimited VOP Supplier of the Year 2020 Randstad Premier Supplier 2021-2023 TAPFIN Premier Partner 2017-2018 Workforce Logiq Proven Performer 2016-2020 First Data #1 supplier for 12 Quarters Thermo Fisher Supplier of the Quarter Toyota Best in Compliance & Retention Excellence Dominion Energy Supplier of the Year 2020 Western Union Supplier of the Year 2017 Top Supplier for PerkinElmer, VISA, Mass Mutual, and more! We currently have workforce in 46 states & 12+ countries for customers such as Amazon, Apple, VISA, Exelon, Securian, Salesforce, Dropbox, Twitter, Otsuka, Adobe, Western Union, First Data, FIS, SANOFI, Merck, Abbott, Roche, Dell, and Corning among many others. We are headquartered in Natick, MA (Boston) along with operations in New Jersey, Virginia, North Carolina, Canada, India as well as remote Executives strategically placed nationwide. Check us out at www.TalentBurst.com or via Linkedin or Facebook

Company details

Company typeLarge
IndustryStaffing & Recruiting
Company size1001 - 5000

Links

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Job description

Title: Clinical Trial Consultant II
Location: Remote (Preferred EST)
Duration: 1 Year
​Number of Hours per week: 40 per weeks

Job Scope:
Responsible for case processing and/or QC of clinical trial ICSRs and postmarket case processing from sanctioned countries.

Key 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

Essential Skills and Qualifications 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

Education and Experience Requirements for Job:
Education : Bachelor's degree in science or healthcare related field
Experience : 4+ years experience in pharmacovigilance

Why TalentBurst?
At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.

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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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