Función del empleo: Research & Innovation

Tipo de puesto: Permanent

Tipo de empleo: Full - Time

Localización: Clark, NJ

País: United States

Sr. Scientist I

  • The Sr. Scientist is responsible for independently conducting technical reviews and monitoring process-related activities in the Vigilance group for all Over-the-Counter (OTC) Drugs and Cosmetic products sold in the USA. The main activities include:
  • Ensure the prioritization, completion, accuracy & validity of data entry for initial and follow-up Adverse Events (AEs) for both OTC Drugs & Cosmetic products in compliance with company Standard Operating Procedures (SOPs) and any applicable global regulatory guidelines
  • Ensure the completion, review and submission of all MedWatch Reports to FDA
  • Coordination & document management of Sharepoint files including organization of department training documents and maintenance of FDA correspondence
  • Review and complete medical assessments and determine seriousness criteria
  • Responsible for the triage of incoming Health Related Complaint cases, assessing if the cases meet criteria for an Adverse Event, determine and confirm timing of events, complete data entry compose narratives and MedDRA coding into the proprietary company safety database
  • Prepare & perform Quality Assessment on serious expedited MedWatch Reports and ensure timely submission to the FDA 
  • Provide feedback using discretion regarding database issues or with case details that are documented by our Consumer Care Center (CCC) and communicate database discrepancies
  • Perform medical assessment of case reports for seriousness, causality and expectedness
  • Ensure completion of daily case reconciliation process
  • Coordination & document management of Sharepoint files including organization of department training documents and maintenance of FDA correspondence
  • Ensure that Heath Related Quality Complaints that require investigation are analyzed promptly and forwarded to the plants, responses are consolidated and tracked, as well as maintaining records in Sharepoint
  • Provide patch test letters/kits for physicians when requested and follow-up the results once the skin investigations performed
  • Along with the Vigilance Manager & Sr. Vigilance Coordinator, serve as a point of contact regarding case inquiries from CCC or PMS French Colleagues.
  • Assist Manager to provide data entry training to new and permanent contract employees
  • Promptly perform vigilance database queries as requested from Regulatory, Product Safety or Global PMS
  • Assist Manager to review/update SOPs & WPs as needed
  • Work together with Manager & Sr. Vigilance Coordinator in safety signal activities by reviewing aggregate data, monitoring trends of reporting for Americas Region as needed
  • Pharm D, R. Ph or RN preferred with case processing & medical assessment experience and a working knowledge of basic medical terminology
  • Minimum of up to 2 years’ relevant experience in consumer products (OTC Drugs and Cosmetics)
  • Experience in the skill of MedDRA coding
  • Understanding of US Regulations and FDA compliance timelines
  • Basic knowledge of medical terminology
  • Proficient in Microsoft Excel and Word
  • Organization and written communication skills
  • Ensures compliance with company policies, procedures, and standards
  • Ability to work effectively in a team
  • Must be legally eligible to work in the US on an on-going basis
  • Data entry of Adverse Events, & medical assessment of Adverse Events, ensuring prioritization of workload, processing of FDA submissions & document retention, while working with other Sr. Scientist, Vigilance Coordinators, Medical Physicians & Post-marketing Surveillance Manager.
  • Reports to Post-marketing Surveillance Manager and can also operate independently; would require minimal supervision when needed.

We are an Equal Opportunity Employer and take pride in a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, sexual orientation, national origin, age, marital or veteran status, medical condition or disability, or any other legally protected status.

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