Medical Director/ Safety Physician - Home Based

PRA Health Sciences Raleigh , NC 27611

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
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