Safety Data Management Specialist

Where

Bridgewater, NJ

What you'll be doing

Carry out case processing activities. Review, rank, verify process, and document case-related information: event terms; validity, seriousness, special scenarios; time lines; accuracy and consistency. Review case criteria to determine the appropriate work flow 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 report ability 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.

What your background should be

Zero to one year of health care professional or equivalent experience preferred. Experience in pharmacovigilance and/or data management preferred but not required. Experience and skill with medical writing an advantage. Experience in use and management of relational databases preferred. Ability to work under supervision in a matrix organization. Ability to make basic decisions with an understanding of the consequences.

Required Schooling / Training

BA/BS degree

Who is the client company

This is an American multinational pharmaceutical corporation.
If you are interested in this position, send your resume to apply@kochdavis.com