Back to jobsLiaises with Global Safety, as well as NNI medical, clinical and regulatory, on all relevant safety matters
Narrative writing, medical evaluation of a case, reconciliation of databases, review of protocols, etc.
Provide medical input in the safety review of ICSRs where the US affiliate has case processing responsibilities, namely post-marketing sources
Responsible for performing review of individual safety reports for medical content, evaluation of expectedness/ listedness and assessing regulatory status for expedited reporting, and possible signal detection
Performs aggregate medical review of post-marketing, non-serious adverse events in collaboration with Global Safety
Handles local aggregate report activities, incl. review and safety input for assigned products, e.g. PBRERs, PADERs
Provides guidance and expertise to case processing personnel in triaging and evaluating adverse events and malfunction report with respect to assessment of seriousness, expectedness/ listedness, and causality for FDA reportability. Serves as Patient Safety lead SME in PRB meetings for all assigned NN products
Responsible for the determination of regulatory submissions for ICSRs and performs the quality check of the assessments in collaboration with the case processing teams
Supports internal and external training activities such as Introduction program for new employees in Patient Safety, annual safety training for Patient Safety employees etc.
Complies with all Federal regulations and company SOPs regarding complaint handling and regulatory reporting for adverse experiences, marketed product and clinical investigations
Maintains up to date knowledge of the regulations and guidelines issued by FDA and ICH as well as other industry sources of information concerning current standards for safety surveillance and FDA reportability
Performs gap analysis and impact assessment on new and revised regulatory reporting and safety surveillance regulations and guidelines issued by the FDA
Provides Patient Safety input to assigned products Local Labeling Committee
Reviews and disseminates information from the affiliate mailbox
