Drug Safety Scientist

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How do you spend your day? Are you passionate about what you do? At Novartis, our focus is clear, our purpose defined. We're part of a team that's making a difference in the quality of people's lives.Think What's Possible.Position Description:Process Adverse Event (AE) cases received by Novartis Consumer Health (NCH), Over-the-Counter (OTC), DSP to meet internal requirements and legal obligations for AE case processing, analysis, and reporting to health authorities. Prepare Periodic Safety Update Reports (PSURs) or other reports as assigned. Major Accountabilities:Generate/author complex PSURs, USPRs and other reportsPerform daily responsibilities in accordance with all applicable Standard Operating Procedures (SOPs), conventions and company policiesPerform triage of incoming AE reports (including literature cases) for completeness, consistency and seriousness; prioritize per regulatory and company guidelines (includes reviewing and medically evaluating relevant drug safety information and alerting Medical Surveillance Experts (MSEs) of potential serious case assessments and/or case trends)Generate and track requests for follow-up informationInform Case Processing and Quality, Training & Compliance groups of late casesPerform duplicate searches as neededPerform Quality Control reviews of cases and communicate recommendations to processorsCommunicate changes to affiliates regarding case upgrades (non-serious to serious)Support literature searches for medical inquiries and process assigned casesPerform duplicate check and book-in manual cases as backup to Drug Safety Associates (DSAs) if necessaryIdentify critical missing information and consult with MSEs as requiredOngoing mentorship/training to entry level Drug Safety Scientists (DSS)Perform all duties of DSS I as requiredQualificationsPosition Requirements & EducationExperience: Minimum 4 years of pharmaceutical or related industry experience and 3 years in Drug Safety required; Data entry experience required; Experience preparing aggregate reports preferred; Training and quality assessment experience preferred ; OTC experience preferredEducation: Bachelors degree or equivalent in a medical or healthcare related field required (RN, BSN, Nurse Practitioner, Pharmacist, Physician Asst)
Novartis is committed to embracing and leveraging diverse backgrounds. Novartis is an equal opportunity employer M/F/D/V.To apply for this position, Click HereTo learn about other Novartis opportunities, Click Here