Insmed Incorporated

  • EU-Qualified Person Responsible for Pharmacovigilance (EU-QPPV)

    ID
    2019-1220
    Job Function
    Drug Safety & PV
  • Company Description

    At Insmed we are on a mission to transform the lives of patients battling serious rare diseases. We are developing novel, targeted therapies to help serve the critical unmet needs of these patients. In concert with developing therapeutic solutions, we are committed to improving the entire patient experience, from diagnosis and treatment to everyday living.

    Overview

    The QPPV will establish and maintain Insmed’s PV system to ensure compliance with all legal and regulatory requirements in the EU for the applicable Marketing Authorisations. The QPPV will be responsible to maintain oversight of the safety profiles and any emerging safety concerns in relation to the medicinal products for which Insmed holds authorisations in the EU and will be the point of contact with all EMA/EU competent authorities related to safety.

    Responsibilities

    • Establish, maintain and provide oversight for the Insmed PV system to ensure compliance with all legal and regulatory requirements for Insmed EU marketing authorisations
    • Maintain oversight of the safety profiles and any emerging safety concerns for Insmed EU market authorisations
    • Ensure continuous monitoring of the safety profiles of Insmed products
    • Act as the main point of contact with EU competent authorities for Pharmacovigilance
    • Be available to be contacted by EMA and EU Competent Authorities 24 hours a day, 7 days a week
    • Ensure Deputy QPPV availability during planned and unplanned absence
    • Delegate tasks whilst maintaining final responsibility
    • Provide oversight and/or support for the following (in agreement with the Head of Safety):
      • PSMF
      • Sources of Safety Information
      • ICSR Submissions
      • Global Safety Database
      • Standard Operating Procedures (SOP)
      • Aggregate Reports such as PSURs
      • Risk management Plans (RMP’s) and Risk Minimization Strategies
      • Post Marketing PV Commitments and Post Authorization Safety Study (PASS)
      • PV Quality Management System: Including audits, CAPAs, Quality Events, Deviations, Global PV Inspections
      • Evaluation of Safety Data, Signal Detection and Management Activities
      • Reference Safety Information (Labelling and CCDS)
      • Contracts and agreements

    Qualifications

    • At least 10 years of PV experience in the pharmaceutical industry and/or an EU regulatory authority
    • The most recent 5 years of experience should be devoted to working in a PV department as QPPV, Deputy QPPV or in the QPPV Office role
    • Healthcare Professional (MD, Pharmacist, Nurse)
    • Must reside in the EU
    • Strong post-marketing documentation skills
    • Must have experience in oversight of PSMF’s, PSURs, RMPs, PV Quality Management Systems
    • Must have strong working knowledge of European laws and regulations related to Pharmacovigilance, GPV Guidelines, ICH
    • Experience in EU Competent Authority and EMA Inspections
    • Device experience strongly preferred
    • Strong Leadership skills and ability to communicate with individuals at all levels (administrative to key thought leaders)
    • Excellent oral and written communication skills
    • Excellent analytical skills and ability to work independently
    • Strong interpersonal, negotiating and team building skills
    • Ability to exercise creativity and judgment

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