SeniorPharmacovigilanceSpecialist

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. **Essential Functions:** * Responsible for overseeing and performing daily case processing of adverse event cases (clinical trial and/or post marketed), including coding using MedDRA, determining seriousness and expectedness at the event and case level. * Perform case follow up activities such as identification of information to be collected during follow-up. * Creating and reviewing case narratives. * Providing client notifications as required for case management. * Supporting and contributing to the development of training materials and training delivery. * Highlight areas of concern/discrepancies to the Principal PV Specialist, Case Processing and/or Manager, Case Processing when related to ICSRs. * Acquire and maintain an up-to-date knowledge of global safety regulations for medicines. * Peer reviews of cases for quality, consistency, and accuracy. * Provide oversight and direction of PV deliverables as a PV subject matter expert as needed. * Perform Health Care Professional (HCP) review (as required). * Mentors and trains less experienced staff. * Other duties as assigned. **Necessary Skills and Abilities:** * Strong verbal, written and interpersonal communication skills. * Intermediate project management skills. * High level of accuracy and attention to detai