• Pharmacovigilance Manager

    Posting Date 5 months ago(6/1/2018 11:17 AM)
    Requisition ID
    2018-4638
    Job Location(s)
    Pittsburgh PA United States
    Travel
    10-20%
    Position Type
    Full Time
    Company
    Cook Myosite Inc.
    Category
    Clinical
  • Overview

    Cook MyoSite Incorporated, a division of Cook Incorporated, is a growing, forward-thinking biotechnology organization seeking a full time Pharmacovigilance Manager. The Pharmacovigilance Manager leads the clinical safety program to manage safety surveillance and ensure thorough and effective monitoring, analysis, and reporting of safety information related to all clinical studies across all clinical development programs.  This role is also responsible for ongoing development and execution of clinical risk management strategies, and actively collaborating with other team members and functions to advance long-range strategic plans for clinical and post-market safety programs. 

     

    Responsibilities

    • Active governance of GCP safety-related policies, procedures, operating guidelines, and ensuring their operational implementation
    • Compilation and management of aggregate safety data for regulatory reporting (e.g. DSUR), as well as responses to safety related health authority requests
    • Ensuring the accuracy and completeness of safety sections of applicable clinical documents (e.g., protocols, investigator brochures, study reports, informed consent forms, etc.)
    • Managing and maintaining an electronic global safety database for tracking, storing, and reporting adverse events of all investigational and future marketed products
    • Ensuring the accuracy and quality of study safety data analysis, interpretation, and reporting
    • Overseeing and ensuring the thorough medical review (e.g. seriousness, relatedness, expectedness) of individual case safety reports or AE’s/SAE’s
    • Initiating and writing queries to clarify information received from individual safety case reports or product complaints, where necessary
    • Obtaining compliance related medical assessments, and general medical leadership as needed for matters that may arise during clinical trial execution
    • Developing and maintaining general safety signal management methodologies and product specific signaling strategies
    • Coordinate regular product safety signaling meetings to evaluate safety information, and ensure the rationale to support any changes to the safety profile of the assigned product(s)
    • Providing support for publication of data and disease or technology related scientific publications
    • Providing functional support and input to establish and manage vendor relationships (e.g., contract agreements, vendor oversight, risk and safety management plans)
    • Managing, mentoring, and developing internal safety operations personnel as the department expands

    Qualifications

    • Academic degree in Pharmacy, Nursing, Epidemiology, Immunology or health care related profession is required; MPH, Pharm D, PhD, or NP preferred
    • Minimum 5 years drug safety and/or clinical research and safety experience in the pharmaceutical industry required
    • Experience in performance management of pharmacovigilance systems, including signal detection/surveillance, required
    • Proficiency in use of industry-standard software (e.g. Microsoft Office Suite, WebEx, electronic data capture systems [RAVE, InForm], and drug safety databases [Argus], MedDRA coding), is required
    • Previous experience working with CROs, vendors, and relationship management preferred
    • Experience with regulatory inspections and company audits including MHRA/EMA PV inspections preferred
    • Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data to both healthcare professionals (HCPs) and non-HCPs
    • Thorough understanding of the drug development process and context applicable to safety surveillance activities
    • Strong working knowledge of global PV requirements (e.g., US Code of Federal (CFR) regulations; Volume 10 clinical trials directive; Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines)
    • Knowledge of MedDRA terminology and its application
    • Experience in the preparation and authoring of pre- and post-aggregate safety reports, Risk Management Plans, and Reference Safety Information
    • Fluency, both written and oral, in English

     

    Physical Requirements:
    • Willingness to travel up to ~10-20%, with international travel at times

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