PRAHS

  • Manager of Drug Safety Center

    Job Locations (All) | Japan
    Posted Date 3 weeks ago(10/25/2018 3:58 AM)
    ID
    2018-49915
  • Overview

    Providing innovative solutions for our clients is what we do. But innovation just for the sake of innovation isn’t why we do it. Side-by-side with our clients, we strive to move drug discovery forward, to help them develop life-saving and life-improving drugs. We help change people’s lives for the better every single day. It’s who we are. And it’s who you could be too.

     

     

    Working fully embedded within one of our pharmaceutical clients, with the support of PRA right behind you, you’ll be at the heart of our client’s innovation.

    Responsibilities

    You will manage the group Drug Safety Associates and other personnel within the Drug Safety Centre to provide services for SAE/ADR management, periodic safety reports, SOPs, investigation of process-related issues, consulting on safety processes, tools, and regulatory compliance.  You will provide leadership in the implementation of PRA’s quality initiatives and business processes and possess the following skills:

    • Ensuring that staff fulfil their responsibilities in accordance with policies, procedures, and SOPs
    • Managing operational functions of a Drug Safety Associate group within the Drug Safety Centre to meet project objectives with SAE/ADR management, periodic safety reports, safety consulting on processes, tools, regulatory requirements related managing the safety of drugs, vaccines and devices
    • Building and aligning a technical team to perform critical operating tasks to achieve results
    • Technical oversight of the generation of project plans such as Safety and Medical Management plans (SMMP) in close cooperation with project team during set-up phase
    • Maintaining familiarity with current industry practices and regulatory requirements that affect analysis and reporting, submissions of NDAs and PLAs

    Qualifications

    An experienced, ambitious self-starter looking for the opportunity to prove yourself in an aggressively growing industry.   

     

    Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

    • Pharmaceutical or contract research organization experience including project leadership and management of technical staff

    • Knowledge relevant to ICH statistical analysis guidelines, report writing guidelines and regulatory submission requirements for human drugs in Japan

    • Fluency in English

     

    Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better. 

     

    PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace. 

     

    For more information please visit our website: www.prahs.com 

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