Demo

Scientist

Kelly Science, Engineering, Technology & Telecom
Clark, NJ Full Time
POSTED ON 1/29/2025
AVAILABLE BEFORE 4/27/2025

Scientist

  • Location : Clark, NJ
  • Type : W2 contract (NO C2C OR THIRD PARTY)
  • Length : Until 8 / 2025 (Contract extension expectation)
  • Pay Rate – $29.41 hourly
  • Work Authorization - Must be able to work in the U.S. with approved authorization status.

What You'll Do :

  • Prioritization of workload for US OTC / Medical Devices (MD) & Hospital visit cases, data entry, MedDRA coding and completion of case narratives of incoming potential Health Related Complaints (HRCs) into the Post-marketing Safety (PMS) database while ensuring completeness and legibility.
  • Reconciliation of daily cases received from Consumer Care Center (CCC), identify missing cases, correct errors in the Salesforce database & notify CCC manager of discrepancies.
  • Provide feedback using discretion regarding database issues or with case details that are documented by CCC and communicate database discrepancies.
  • Support PMS team members with projects regarding completion of cases with missing data or formula numbers as needed and serve as a backup for preparing statistical reports.
  • Perform data extractions for global PMS analyses and validate data.
  • Provide ongoing training / feedback of operating tools coordinating with colleagues in France to ensure accuracy.
  • Provide prompt queries of vendor’s database to review all AEs received, notify appropriate partner contacts, review for potential quality-related complaints, notification of manufacturing sites, while maintaining appropriate recording and archiving of information.
  • Conduct database and data entry training of PMS newcomers within the Americas zone.
  • Ensure documentation management of departmental work files, including organization of department training documents, Quality Investigations, and maintenance of FDA correspondence.
  • Review / update standard operating procedures (SOP) and work processes (WP) as needed.
  • Participate in department presentations to CCC or other métiers.
  • Ensures compliance with company policies, procedures, and standards.
  • Ensuring prioritization of data entry workload (OTC / Hospital / MD cases), data exploitation / validation working with colleagues in Global Data Management, ensure department document retention, while working with other Sr. Scientists, Vigilance Coordinators & Head of Post-Marketing Safety.
  • Qualifications :

  • A completed BS or MS in biology or a related field preferred with case processing experience & relevant data exploitation experience in pharmacovigilance.
  • Minimum of 3-5 years of relevant experience.
  • Experience in MedDRA coding preferred.
  • Basic understanding of US Regulations pertaining to Post Marketing Safety preferred.
  • Knowledge of medical terminology preferred.
  • Excellent communication (verbal, written) and interpersonal skills required.
  • Well organized while handling multiple projects simultaneously.
  • Demonstrated skills in analyzing, reporting, and documenting information with strong attention to detail.
  • Ability to work independently with minimum supervision in a matrix environment.
  • Important information :

  • To be immediately considered, please send an updated version of your resume to Danh704@kellyservices.com
  • Kelly does not expense relocation / interview costs)
  • In addition to working with the world’s most recognized and trusted name in staffing, Kelly employees can expect :

  • Competitive pay
  • Paid holidays
  • Year-end bonus program
  • Recognition and incentive programs
  • Access to continuing education via the Kelly Learning Center
  • Salary : $29

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