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Safety Data Management Specialist

  • Unicon Pharma
  • 02/20/21
  • Peapack, NJ
  • 07977
  • 33.00 / Hourly
  • Contractor
Job Description:
Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of clients products and to meet regulatory requirements. Determination of local submission of individual and, where appropriate, aggregate safety reports
Carry out case processing activities
Review, rank, verify, process and document case-related information: terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments
Review case criteria to determine appropriate workflow for case processing
Assess case to distinguish those with particular complexities and/or specific issues, and escalate appropriately
Write and edit case narrative
Determine and perform appropriate case follow-up, including generation of follow-up requests

Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios
Liaise with key partners, locally, and other stakeholders regarding safety data collection and data reconciliation
Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database
Determine reportability of scheduled reports, ensuring adherence to regulatory requirements
Consistently apply regulatory requirements and policies
Participate, as appropriate, in local, internal and external safety activities

Reports to Country Safety Lead or Safety Team Lead or Safety Officer (depending on local organization and safety group size)
Experience in pharmacovigilance and/or data management preferred but not required
Experience and skill with medical writing an advantage
Demonstrated computer literacy
Experience in use and management of relational databases preferred

Additional Requirements:
Health care Professional or equivalent experience preferred
Ability, with supervison, to solve routine problems and to surface issues constructively
Ability to make basic decisions with an understanding of the consequences
Ability to achieve personal objectives while meeting departmental standard of performance
Ability to work under supervison in a matrix organization
Fluency in spoken and written English

Employer Information

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