Advanced Clinical

  • Director, Pharmacovigilance

    Job Locations US-IL-Deerfield
    Req No.
    2018-9569
    Type
    Regular Full-Time
  • Overview

    Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there’s no better place to grow your career than Advanced Clinical.

     

     

     

    Responsibilities

    The Director, Pharmacovigilance & Safety Monitoring serves as the primary medical point of contact for a project or study.  The Director, Pharmacovigilance & Safety Monitoring effectively manages medical and safety review, processes, and projects for assigned clinical studies. The Director, Pharmacovigilance & Safety Monitoring may be an employee, or a consultant may fill this role for a given period of time.

     

    Essential Functions

     

    • Oversees medical review of key clinical documents, individual case safety reports, and medical or safety-related regulatory documents
    • Provides support and input into the planning, design, preparation, initiation, and execution of study protocols and other required documentation in compliance with project plans, federal regulations, GCP, and good medical practice.
    • May participate in the evaluation and selection of investigators and study sites as well as analysis of medical activities
    • Provides medical/clinical direction to investigative sites per contract deliverables
    • Prepares medical and safety plans for clinical trials
    • Collects, reviews, provides guidance and manages overall safety case processing as dictated by client contracts
    • Reviews and directs medical and safety sections of regulatory document submissions
    • Participates in Investigator meetings
    • Develops and assists other staff in the development of processes, timelines, planning, and strategy
    • Facilitates collaboration and communication with medical/scientific personnel and ensures that the most current research information is accessible for review

    Qualifications

    Requires an excellent understanding of the clinical/pharmaceutical process so as to effectively communicate and create required deliverables. Possesses advanced knowledge of, and ability to, apply GCP and all applicable regulations and guidelines. Possesses exceptional leadership skills and proven industry vision. Requires effective negotiation and interpersonal communication skills to interact with a variety of peers and constituents. Must have the ability to understand complex clinical and statistical data and issues from an analytic standpoint.

    • Education: MD or DO required
    • Training GCP (including 21 CFR 11), HIPAA – Privacy Rule and Protected Health Information
    • Certification: Preferably board certified in the US
    • Experience: Minimum of eight (8) years of clinical research and medical/safety management experience in the pharmaceutical industry

    What’s in it for you? Advanced Group offers competitive compensation, comprehensive benefits packages, and a flexible work environment designed to help our team members and their families stay healthy, meet their financial goals, and generally thrive in and beyond work. Visit the links below to discover all that Advanced Group has to offer:

     

    Our Culture: https://careers.advancedgroup.com/embrace-our-culture

    Career Development Opportunities: https://careers.advancedgroup.com/realize-your-potential

    Community Programs: https://careers.advancedgroup.com/unleash-your-passion

    For a complete list of all of our job openings, please visit Advanced Group’s career site here.

     

    It is Advanced Group’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.


    This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job.  If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

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