Senior Manager, Pharmacovigilance & Epidemiology: Los Angeles

Senior Manager, Pharmacovigilance & Epidemiology: Los Angeles

October 1st, 2019 by

Job Description

  • The Senior Manager, Pharmacovigilance & Epidemiology is responsible for or supports various pharmacovigilance and risk management/minimization activities for ┬áinvestigational 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 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.

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