• Pharmacovigilance Standards Manager

    Job Locations - | United Kingdom
    Posted Date 1 month ago(5/17/2018 6:55 AM)
  • 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.


    We are currently recruiting a Pharmacovigilance Standards Manager to support one of our PV & Patient Safety (PVS) teams in our location in Central London, UK.

    He/She is responsible for and participates involving the revision of existing and new SOPs or development of policy and procedure documents and supporting documents associated with any PV process or procedure to effectively meet operational and regulatory requirements. 

    • Support and monitoring of all PV documents through the QMS review and approval process, including training assignments within the LMS.
    • Provide alignment and assign priority to multiple updates, initiatives and timelines that may concurrently impact a document.
    • QC of document packages prior to QA submission to minimize errors that will delay review and approval.
    • Managing timelines and stakeholder approval and support including Japan.
    • Support author with resolution of comments. If significant comments require further discussion, initiate meetings with functional areas
    • Partner with Authors to support management of QMS CAPA timeline expectations, CAPA extension requests and monitoring throughput of documents through QMS approval process, as needed.
    • Established document tracking and elevation plan to better address delays in QMS process that may risk compliance to CAPA due dates.


    Location: This role is based in Central London.


    You have

    • Minimum 3 years’ experience in Pharmacovigilance/Patient Safety
    • Experience in writing policy and procedure documentation in the pharmaceutical areas.
    • Demonstrated experience and ability to develop comprehensive policy and procedure documentation in accordance with regulations
    • Excellent writing, editing, proofreading, and process mapping skills
    • Excellent written and verbal communication skills, with the ability to communicate and interact effectively with all levels of personnel.
    • Proficiency in MS Word, Excel, PowerPoint, Outlook, and other software applications, such as Visio and Adobe Acrobat Pro.
    • Effective decision-making skills, sound judgement, and strong technical aptitude.
    • Strong organization and analytical skills, with strong attention to detail.
    • Strong self-starter and self-motivator, with the ability to work autonomously.


    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:


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