Safety Risk Management Lead (Senior Manager)

Location
Boston, MA, United States
Posted
Mar 27, 2021
Ref
2ADC93C85C
Hotbed
Genetown
Required Education
Other
Position Type
Full time
Location: London

Reporting to: Head of Safety Risk Management

Orchard Therapeutics is a leading global fully integrated commercial-stage company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies. Orchard's portfolio of autologous ex vivo gene therapy programs has demonstrated sustained clinical benefit in over 150 patients across five disease areas. These programs include Strimvelis®, the first autologous ex vivo gene therapy approved by the EMA in 2016, 3 programs in advanced registrational studies in MLD (metachromatic leukodystrophy), WAS (Wiskott Aldrich syndrome) and ADA-SCID (adenosine deaminase severe combined immunodeficiency), 2 other clinical programs in X-CGD (X-linked chronic granulomatous disease) and beta-thalassemia, as well as an extensive preclinical pipeline.

Responsibilities

The Safety Risk Management Lead is responsible for supporting global PV activities and deliverables for the Safety Risk Management team, including:

  • Production of aggregate reports and coordination of collaborator review and approvals
  • Collating safety data from post-marketing sources and from clinical trials for the purpose of signal management
  • Maintaining signal management tools and trackers
  • Archiving supporting documentation for Safety Risk Management activities
  • Production of controlled documents for Safety Risk Management processes.


  • Requirements

    Requirements
    • Production and coordination of collaboration, review, and finalization of aggregate reports for assigned products
    • Leads the signal management process (i.e., signal detection, record management and scheduling Safety Management meetings, etc.) for post-marketing product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities for investigational products. Includes synthesis of data from multiple sources and authoring signal evaluation reports.
    • Oversees collection, in cooperation with medical monitors, of the interim data from ongoing studies for safety management activities.
    • Records and archives decisions and action items resulting from signal management meetings.
    • Ensures compliance to signal management activities as defined on the signal management activities tracker
    • Involved in the coordination process for responding to safety questions from regulatory authorities


    • Creating and maintaining controlled processes.

    Education & Skills

    • Prior experience in pharmacovigilance or clinical development.
    • Knowledge of pre- and post- marketing pharmacovigilance regulations whereas Orchard's products are in clinical development and/or on the market
    • Excellent grammatical, editorial and proofreading skills
    • Effective organizational and planning skills
    • Understands, interprets, analyses, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).
    • Develop and maintain relationships with program counterparts in Clinical Development, Regulatory, Clinical Operations, Medical Affairs and other internal departments