Bridgewater, NJ - Drug Safety Data Management Specialist

Job Description:

• Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of the company’s 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: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency
• Process cases based on these assessments
• Review case criteria to determine the appropriate workflow for case processing
• Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately
• Write and edit the 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 company policies
• Participate, as appropriate, in local, internal and external safety activities

REQUIREMENTS:

• Regulatory Documentation: Regulatory Knowledge Required 1-3 Years
• Ability, with supervision, 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 standards of performance
• Ability to work under supervision in a matrix organization
• Health Care Professional required
• 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
• Excellent oral and written communication skills
• Fluency in spoken and written English

SUBMIT RESUME to Resume@ABOUT-Consulting.com
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