Karyopharm Therapeutics Inc.

  • Medical Director, Pharmacovigilance

    Job Locations US-MA-Newton
    Job ID
    2018-1081
    # of Openings
    1
    Category
    Other
    Type
    Regular Full-Time
  • Overview

    Karyopharm Therapeutics is a clinical-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.

    Responsibilities

    The Medical Director, Pharmacovigilance (PV) will report to Sr Medical Director, PV. He/she will provide broad support of activities requiring medical safety input for assigned products, pre- and post-approval. He/she will support and/or lead periodic safety signaling reviews and meetings, as well as perform individual and aggregate case review. He/she will also participate, in varying degrees, on clinical teams/programs and other intra and/or inter-departmental activities and initiatives.

    • Represent department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issues.
    • Provide timely and sound medical review of individual case safety reports from clinical trials or post-marketing sources as needed.
    • Participate in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans.
    • Participate in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports.
    • Contribute to preparation and review of periodic reports (IND, Annual Safety, DSUR, PSURs, CSR).
    • Review and provide medical content, as needed, for key study-related documents, e.g. IB, ICF, IDMC Charter.
    • Participate in departmental development activities including SOP and Work Instructions development.
    • Provide guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective.
    • Provide a contributory role in Partner /Affiliate agreements and interactions, as needed.
    • As directed by the PV Head, assume primary responsibility/chair for the conduct of one or more Safety Team(s) for assigned products.
    • Participate in the regular review of safety data for assigned products for the identification of new safety signals, in accordance with signal detection practices.
    • Participate in Risk Management Strategy.

     

    Qualifications

    • MD, DO or equivalent.
    • Minimum of 5 years Drug Safety/Pharmacovigilance or Medical Monitor experience.
    • Solid knowledge of General Medicine, MD, DO, MBBS.
    • Adequate knowledge of GCP, ICH and Global regulations.
    • Prior NDA experience and oncology experience preferred.
    • Experienced in the evaluation and interpretation of data.
    • Ability to multi-task.
    • Solid written and oral communication skills.
    • Solid judgment and decision-making skills, including the identification and communication of relevant safety- related issues or concerns to Medical Safety Management in an appropriate and timely manner.
    • Experienced in safety reviews of AEs/SAEs, IBs, protocols, clinical study reports, informed consents, and other safety-related documents.
    • Close attention to detail.

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