Karyopharm Therapeutics Inc.

  • Pharmacovigilance Compliance Specialist/Sr Specialist

    Job Locations US-MA-Newton
    Job ID
    2019-1335
    # of Openings
    1
    Category
    Research and Development
    Type
    Regular Full-Time
  • Responsibilities

    The Pharmacovigilance (PV) Compliance Specialist/Sr Specialist reports to the Manager of PV Compliance and performs specific work delegated by Pharmacovigilance management.  Responsibilities include but not limited to:

    • Support deviation documentation, training and CAPAs
    • Assist with PSMF maintenance
    • Assist with establishing an inspection readiness process for pharmacovigilance
    • Assist with audit/inspection responses from Pharmacovigilance and external partners/vendors and evaluate proposed corrections, corrective actions, and or preventative actions for compliance with applicable regulations, guidelines and Karyopharm policies
    • Track and Monitor compliance (ICSRs to Health Authorities, Partners, & Central Ethics Committees)
    • Utilize PVQ to generate metrics and reports for senior management
    • Monitor activities of CROs/business partners to ensure adherence and compliance with applicable SMPs, KPIs/Metrics, PVAs and other contractual agreements
    • Interface with internal and external stakeholders and ensure that the appropriate contact points are established with the other groups (e.g., Quality, Regulatory Affairs, etc.) to respond and address gaps or compliance issues that need resolution by team specialists
    • Assist in monitoring department adherence and compliance regarding training with SOPs, and other PV specific procedural documents

    Qualifications

    • Minimum of B.S. or the equivalent combination of relevant education and professional experience
    • 3+ years’ experience in Pharmacovigilance compliance preferred
    • Ideally have a working knowledge of Argus and PVQ
    • Broad understanding of relevant US, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments is desirable
    • Excellent communication skills, both written and verbal
    • Strong computer skills (MS Office), especially in Excel is a plus
    • Strong analytical and problem-solving skills
    • Strong organizational skills and very detail oriented
    • Ability to identify opportunities for continuous improvement
    • Excellent multi-tasking skills and ability to manage competing priorities

    Overview

    Karyopharm Therapeutics is a clinical-stage pharmaceutical company, based in Newton, MA, USA, focused on the discovery, development and commercialization of novel, first-in-class agents targeting nuclear transport for the treatment of cancer and other major diseases. Karyopharm is the industry leader in oral Selective Inhibitor of Nuclear Export (SINE) technology, developed to address a central mechanism of oncogenesis via the inhibition of exportins specifically XPO1. Selinexor, Karyopharm’s lead candidate, has been administered to patients with hematologic malignancies or solid tumors in clinical trials worldwide. Karyopharm is currently preparing for its first potential U.S. commercial launch in 2019.

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