Senior Manager, Pharmacovigilance & Epidemiology: Los Angeles

The Senior Manager, Pharmacovigilance & Epidemiology is responsible for or supports various pharmacovigilance and risk management/minimization activities for investigational and marketed products Responsibilities (include but are not limited to): Author and coordinate/project manage development of periodic safety reports (e.g., PSUR/PBRER, PADER, DSUR, etc) in accordance with Kite SOPs and regulatory requirements Support preparation and maintenance of Risk Management plans Contribute to development of signal detection strategy for post marketed products Support signal detection, evaluation and management according to SOPs and guidelines Support development and/or maintenance of core and local label for products (e.g., CDS, USPI, SmPC, IB, etc) Serve as the Safety Lead for one or more clinical programs Assist in oversight of PV vendors/CROs as applicable Contribute to preparing safety assessments reports Participate in preparing responses to safety related requests from health authorities Provide safety content review of clinical protocols, CSRs, and ICFs Requirements: Bachelor’s level degree in life sciences required; PharmD or PhD highly preferred. At least 5 years of direct Pharmacovigilance Safety Science is required. Solid knowledge of FDA, EMA, and ICH safety reporting regulations and GVP guidelines. Strong knowledge of safety database (preferably ARGUS), MedDRA, and WHO Drug Strong quality focus, with a good understanding of quality systems. Excellent communicator, both oral and written, specifically medical writing skills Ability to critically analyze individual and aggregate safety data with scientific rigor Previous experience in preparing periodic safety reports and risk management plans Excellent written and verbal communication skills to a variety of levels and teams, internally and externally. #J-18808-Ljbffr TANNER & ASSOC INC