Junior) Safety Data Management Specialist (m/f)

REFERENZNUMMER:

289728/11

IHRE AUFGABEN:

-Carry out case processing activities regarding adverse events/adverse drug reactions
-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
-Participate, as appropriate, in local, internal and external safety activities

IHRE QUALIFIKATIONEN:

-Professional experience in health care or equivalent experience preferred
-Experience in pharmacovigilance and/or data management, clinical care or clinical/scientific research preferred but not required
-Experience in use and management of relational databases preferred
-Good knowledge regarding medical terminology
-Ability to solve routine problems under supervision and to surface issues constructively
-Ability to make basic decisions with an understanding of the consequences
-Fluency in spoken and written English and German
-Good understanding of written French is an advantage
-Good knowledge of Italian is an advantage

WEITERE QUALIFIKATIONEN:

Drug safety manager