Position Title: Scientist I, Post Market Safety & Cosmetovigilance
Location: Clark, New Jersey (Hybrid)
3 month contract
Must be able to work on a W2
We are seeking a Scientist to join our Post Market Safety & Cosmetovigilance team in our Clark, New Jersey Research facility. The Post Marketing Safety group has direct responsibilities for cosmetovigilance operations for the United States and close collaborations across the Americas Zone. This position is responsible for the receipt and data entry of both initial and follow-up Adverse Events (AEs) for Over-the-Counter (OTC) & Cosmetic products marketed in US, while ensuring data accuracy, case validity, compliance with relevant regulations, Standard Operating Procedures (SOPs) and Work Practices (WP). In addition, the Senior Scientist will interface with the Product Safety Evaluation group for the safety assessment of products, including data extraction for the review of individual and aggregate AEs. This is required for cumulative review and medical assessment of cases worldwide and is key to ensure the determine any safety signals with marketed products. In addition, the Senior Scientist will collaborate with PMS & Worldwide Safety Evaluation Data Management for developing methods, tools and analysis.
As a Scientist in our Post Market Safety & Cosmetovigilance team, your main responsibilities are:
• 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.
To Succeed in this Position, You Have:
• 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.
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