Karyopharm Therapeutics Inc.

  • Manager/Senior Manager, Pharmacovigilance Compliance

    Job Locations US-MA-Newton
    Job ID
    2018-1229
    # 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 Manager/Sr Manager, PV Compliance is a key role and will provide expertise and leadership in developing, implementing, and maintaining a robust global compliance program within the Pharmacovigilance Department.  The PV Compliance Manager will also be responsible for ensuring appropriate and applicable training of pharmacovigilance staff to ensure compliance with good pharmacovigilance practices, development of metrics and reporting to senior management across all PV activities including but not limited to: case management and reporting, management of external pharmacovigilance vendors, and lead the action plan and resolution of inspection/audit findings and/or corrective actions; preventative actions (CAPAs). 

    The Manager/Sr Manager, PV Compliance will also participate in department and cross-functional meetings with regulatory affairs and quality teams, as well as other intra and/or inter-departmental activities and initiatives. 

    • Assess and develop a robust, global pharmacovigilance compliance program
    • Develop key metrics and reporting process for these metrics to senior management
    • Work closely with all stakeholders in the Pharmacovigilance Department to understand existing processes and procedures, and identify gaps and opportunities for improvement in both effectiveness and efficiency
    • Partner with members from the Quality Department to align compliance processes and procedures with existing or required quality processes
    • Develop a professional relationship with existing pharmacovigilance vendors and establish a management and oversight program to assess both the quality and the compliance of deliverables
    • Assist with end-to-end case processing activities, as needed, within the ARGUS safety database; writing patient narratives, performing quality checks, querying clinical sites
    • Participate in both departmental and cross-functional meetings and initiatives to increase the awareness, education, training, and leadership for pharmacovigilance compliance
    • Identify and support training programs for members of the pharmacovigilance department
    • Develop SOPs and Work Instruction (WI)
    • Other activities, as needed or as requested by manager

     

    Qualifications

    • Bachelor degree in science; advanced degree preferred
    • Minimum of 5 years' experience in Drug Safety/Pharmacovigilance within oncology development programs (post-marketing experience helpful but not required)
    • Solid medical knowledge and understanding to support safety reporting
    • Robust and sound knowledge of GCP, GPV, and ICH regulations regarding drug development
    • Strong knowledge, understanding, and familiarity with ARGUS, with experience in end-to-end case processing for oncology events coming from development program(s)
    • Experienced and demonstrated success in the development and implementation of compliance processes in a pharmacovigilance setting
    • Ability to multi-task in a high-paced, fast-moving environment with changing priorities
    • Solid written and oral communication skills
    • Detail and solution-oriented, able to think outside the conventional “Big Pharma” mentality, and comfortable working in a small company/biotechnology environment

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