Medical Director/ Safety Physician - Home Based

PRA Health Sciences Blue Bell , PA 19422

Posted 2 months ago

Are you a leader, an innovator, a MD passionate about patients but desperate for better work life balance? Are you excited by cutting edge technologies and tools and being part of an award winning company and team that you believe in and invests in you in return?Who are we?We Are PRA. We are 18,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.As a pharmacovigilance Medical Director you will be tasked with:*
  • Perform medical review of individual cases or safety report * Writes/reviews the narrative, performs seriousness, expectedness and causality assessment * Generates medical follow-up queries and contact reporters if necessary * Organize the workflow for a given task or project * Ensure that given timelines are met according to project and regulatory timelines * Process and evaluate AE reports according to the customer's standard operating procedures (SOPs)* Perform CSR signal/trend detection * Perform aggregate line listing signal/trend detection * Contributes in evaluation of emerging safety issues * Contributes in evaluation benefits and risks of a medical compound * Evaluate laboratory values for potential SAEs * Review SAE and AE coding to ensure medical accuracy with the verbatim reported term * Participate in Quality Check activities * Provides therapeutic training relevant to specific study to the project team. * Ensure medical and scientific input in study protocols and reports * Prepare internal SOPs and project specific procedures * Write/participate in writing safety reports (RMPs, PSURs/PEBERs, ARs, SBRs, Issue workups, annual reports/DSURs)* Keep up to date about the relevant regulations, legislation and literature of Pharmacovigilance, pharmacology and pharmacoepidemiology * Attends and/or presents at internal and external project team meetings. * 3 years of experience writing pharmaceutical or health-related documents. * Good communications and presentation skills. * Experience using computerized systems (PC-Windows and MS Office). * Read, write, and speak fluent English; fluent in host country language. * Good project management skills. * Experience in mentoring more junior team members. * Licensed physician * Clinical practice and/or clinical research or drug safety experience. * Broad knowledge of regulatory requirements.Legal Statement: PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities
  • icon no score

    See how you match
    to the job

    Find your dream job anywhere
    with the LiveCareer app.
    Mobile App Icon
    Download the
    LiveCareer app and find
    your dream job anywhere
    App Store Icon Google Play Icon
    lc_ad

    Boost your job search productivity with our
    free Chrome Extension!

    lc_apply_tool GET EXTENSION

    Similar Jobs

    Want to see jobs matched to your resume? Upload One Now! Remove
    Executive Director Of Therapeutic Expertise Home Based

    PRA Health Sciences

    Posted 2 months ago

    VIEW JOBS 3/13/2019 12:00:00 AM 2019-06-11T00:00 The Executive Director of Therapeutic Expertise (DTE) is a leader in internal medicine clinical research and development (R&D) worldwide. * In this role, the DTE: * Consults with PRA clients in developing global therapeutic product strategies and also works closely with Business Development (BD) to help win new business. * Is responsible for the review of Request for Proposals and associated clinical trial protocols in Internal Medicine or Medical Device medicine in cooperation with the assigned leads from other business units, such as Clinical Operations, Medical Affairs, Feasibility, Medical Informatics, and Patient Access & Retention. * Works in a multidisciplinary team to ensure that the appropriate strategies are identified and employed to successfully accrue proposed clinical trials. * Assists clinical operations with training, investigator relations and primary team contact. * Provides oversight and support to the project teams with regard to standard of care, patient recruitment, investigator relations, feasibility, site identification and corporate study experience. * Interacts with clients and participates in client meetings, as necessary, to support and maintain study success. * Develops and maintains long-term professional relationships with relevant personnel in targeted client accounts through regular contact. * Ensures that all administrative responsibilities and reporting requirements are carried out in a timely fashion and according to company policies. * Strategic focus for all projects independent of degree of complexity. Works under general guidance of SVP, but supervision less frequently required. * <li>Medical Doctor (MD) in a discipline relevant for therapeutic product development from an accredited institution and commensurate experience * Extensive Internal Medicine experience across multiple generalist therapeutic areas required. * Substantial functional/technical experience in IM R&D within the pharmaceutical industry or contract research organizations for a minimum of 5 years * Must have phase I and phase IV clinical trial experience * Experience in med device or internal medicine, required * Additional experience working in an academic setting within cardiovascular R&D for several years post-doc, desired * Management experience, including functional department responsibilities, preferred * International clinical development experience is required * Knowledge of databases and data analysis and the ability to interpret and present such data in close conjunction with medical informatics Options are available for an office-based or a home-based position anywhere within the continental United States. * PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities. PRA Health Sciences Blue Bell PA

    Medical Director/ Safety Physician - Home Based

    PRA Health Sciences