PRAHS

  • Manager of Safety Regulatory Intelligence

    Job Locations - | Germany | France | United Kingdom | EU-Remote | Russia | Germany-Nuremberg | Germany-Konstanz
    Posted Date 2 weeks ago(4/6/2018 5:38 AM)
    ID
    2018-45819
  • Overview

    To save lives, or enable people to live better lives, is no small thing. And we know you can’t do it by yourself.

     

    That’s why PRA enjoys a people-first culture of value, respect and support. We feel proud to have fostered a supportive working environment, where flexibility and collaboration reign supreme. And it’s this collaborative culture that drives the development of life-saving treatments for patients around the world.

     

     

    Responsibilities

    The Manager of Safety Regulatory Intelligence is responsible for compilation, maintenance, and distribution of the country-specific regulatory requirements for expedited and aggregate reporting of safety information for medicinal products (drugs, biologics and vaccines) as well as medical devices. This includes the requirements for reporting to Regulatory Authorities, Ethics Committees (ECs) / Institutional Review Boards (IRBs) and Investigators.

    He/She

    • Ensures that information on country-specific regulatory reporting requirements maintained in PRA regulatory repository for reporting of safety information is current and accurate and available for all countries, in which PRA is performing regulatory reporting services on behalf of a client.
      • Ensures that information on country-specific regulatory reporting requirements is reviewed and updated in regular intervals as defined by PRA processes.
      • Ensures that information on regulatory reporting requirements for countries in which PRA will perform regulatory reporting services in the future are collected and compiled timely.
      • Ensures that regulatory reporting requirements are available for PRA project team members and experts in a standardized format, so that it can be used for project work and client consultation.
    • Interacts with Regulatory Authorities, external and internal experts to collect local and national regulatory requirements for expedited and aggregate safety reporting
      • Conducts database searches to collect national regulations relevant for reporting safety information. Understands applicable local/national regulations and translates them into PRA best practices.
      • Documents the interpretation in a standardized format in consultation with the Safety Reporting Team.
      • Releases regulatory information to PRA’s safety database system administrators to update the   reporting algorithms within PRA’s safety database.
    • Makes recommendations in the area of expertise both internally and to clients.
    • Coordinates the Safety Reporting Team:
      • Assigns tasks to Safety Reporting Team in consultation with the responsible Functional Manager
      • Mentors Junior Safety Reporting Team members
      • Prioritizes Safety Reporting Team activities and monitors progress
    • Reviews Safety and Medical Management Plan with regard to documented country specific regulatory requirements for reporting safety information
      • Keeps abreast of current data, trends, regulatory knowledge, developments and advances in the global regulatory environment
    • Provides regulatory and technical training of Safety & Risk Management personnel or other staff, as assigned

     

    Location: This is a global role and can be home-based.

    Qualifications

    A team worker with the ability to influence in order to achieve objectives. You will have excellent organisational skills, flexibility and attention to detail along with a mind-set towards adherence to timelines. 

     

    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:

     

    • Substantial clinical research experience including minimum of 3-5 years experience in drug safety and/or regulatory activities, preferably in drug/device development or clinical research/postmarketing.
    • Experience in cooperating with global teams in a clinical research, postmarketing and/or pharma environment with proven ability to communicate effectively on all levels.
    • Degree in clinical, science, or health-related field from an accredited institution, or equivalent work experience.
    • Skills with industry standard safety or clinical data bases.

     

     

    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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