Karyopharm Therapeutics Inc.

  • PV Scientist/Sr PV Scientist

    Job Locations US-MA-Newton
    Job ID
    2019-1354
    # of Openings
    1
    Category
    Research and Development
    Type
    Regular Full-Time
  • Responsibilities

    The Pharmacovigilance Scientist/Sr PV Scientist supports the medical component of pharmacovigilance activities including:  surveillance activities providing scientific/clinical PV expertise with a focus on the identification, evaluation and management of safety risks for Karyopharm products.  He/She collaborates closely with the safety physician and cross-functional partners to evaluate and actively manage risks in accordance with global regulatory frameworks.

    • Organize and perform independently or collaboratively as necessary, the relevant safety data analysis for Safety Review meeting; ensure adequate documentation of meeting minutes
    • Create and maintain an effective signal tracking process that fully documents signaling activities and can be used for regulatory inspection
    • Support other function teams for Karyopharm investigational products; serve as PV expert and liaise with Clinical Operations, Medical Affairs, Biostatistics, Regulatory Affairs, Contract Research and other entities as needed
    • Contribute to health authority and other safety related query responses
    • Support study teams for Karyopharm investigational products; serve as PV expert and liaise with Clinical Operations, Medical Affairs
    • Demonstrate knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.)
    • Ensure compliance with Karyopharm and PVG & Risk Management policies and procedures
    • Prepares aggregate safety reports (e.g. DSURs, PSURs, RMP), including project management, safety database requests, understanding and writing the content, assimilating information from other groups, and quality checks
    • Plans and executes literature surveillance
    • Provide leadership in the development, implementation, and maintenance of robust procedures for the planning, preparation, and submission of high quality safety reports

    Qualifications

    • PharmD, MD, PhD, MPH, advance healthcare degree, or equivalent professional experience
    • Minimum 2 years’ pharmacovigilance or relevant experience, including at least 2 years’ concentration on aggregate safety report writing
    • Thorough understanding of the drug development process and context applicable to safety surveillance activities
    • Knowledge of MedDRA terminology and its application
    • Excellent written and oral communication skills, strong attention to detail, and high performance standards for quality
    • Ability to analyze, interpret, and summarize complex clinical and medical literature data
    • Ability to prioritize and complete work in a resourceful, self-sufficient manner while maintaining a strong mentality
    • Displays ability to understand established procedures and communicate those procedures to others
    • Exhibits comprehension of industry practices and regulations for drug development and pharmacovigilance
    • Demonstrates awareness of related medical disciplines and an understanding of general concepts and some experiential detail within those areas
    • Possesses computer skills to support use of electronic systems and development of writing deliverables

    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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