Job Description

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 [email protected]
• *** (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

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