Job Description
Prepare the respective submission documents to Health Authorities
Supervision of proper flow of confirmations of receipt of documentation sent to the Health Authorities.
Preparation and everyday distribution of respective DS&E documents externally.
Participation in the verification process of data correctness in the global safety database.
Verification of correctness and compliance of documentation sent to Country Group (CG) DS&E Department
Preparation of the CPO DS&E training materials (incl. confirmations) and logistic organization of these trainings
Archiving all safety documentation as per respective policies, guidance and procedures.
Monitoring the compliance with support of DS&E Associate
Verification and update of respective CG DS&E archiving system (incl. review, update, management)
Manage collection, processing, documentation, reporting and follow-up of all Serious Adverse Events (SAE) reports for all Novartis products from clinical trials, post-marketing studies (PMS), registries, and all adverse events from commercial, sales and marketing programs and all Spontaneous Reports (SR). 11. Transcribe, translate and enter data of all Serious Adverse Events (from Clinical Trials, post-marketing studies (PMS), registries) and all adverse events (from commercial, sales and marketing programs and all Spontaneous Reports) from source documents onto safety systems (e.g. Argus Affiliate) accurately and consistently with emphasis on timeliness and quality.
Record and track receipts, submissions and distributions of SAEs, SRs, Investigator Notifications (IN)/Suspected Unexpected Serious Adverse Reaction (SUSAR), Periodic Safety Report Updates (PSUR) and Development Safety Update Report (DSUR).
Minimum Requirements
Education
Degree in Medicine, Pharmacy OR Life Sciences
Fluent in both written and spoken English
Good working knowledge of local language
Knowledge of French desirable
Experience
Proven ability to work in cross-functional teams
Experience on similar position in drug safety or drug registration or clinical research department would be an additional asset.
Computer technical skills (e.g. Excel, Word, Power Point) and ability to learn new systems quickly.
