Associate Director Drug Safety & Pharmacovigilance
Supports and deputizes the Drug Safety Officer/GPO to ensure adequacy of all drug safety procedures to comply with all applicable regulations;
Is responsible for safety data analysis and presentation, signal detection and benefit-risk assessment in agreement with the Drug Safety Officer/GPO;
Generates/contributes to safety parts of clinical trial related essential documents such as Investigator's Brochure, protocols, patient information and consent form, clinical study reports, clinical (CDP) and product development plan (PDP), and/or has oversight over safety documents prepared in-house or by a CRO (e.g. CIOMS, SMP, DMP, SAP, SAE reconciliation plan);
Generates periodic reports such as DSUR/periodic line listing reports and acts as author of DSURs for MOR programs including managing regulatory submissions.