Senior Pharmacovigilance Specialist, Case Processing - 12 Month Fixed Term (FTC)
The Senior Pharmacovigilance Specialist, Case Processing is tasked with managing pharmacovigilance cases through call intake, documentation, and case processing. This will entail performing the initial assessment of seriousness, expectedness, causality, and reportability of adverse events. In addition, you will also write accurate and complete narratives, report cases in accordance with internal guidelines, SOPs, and Global safety regulations. The role will also require performing case quality checks and signal detection activities and may act as client contact for case management and reporting functions. Ideally, you will proactively maintain a distinctive quality and commitment approach as the operating philosophy in carrying out all processes and will continually seek out ways to enhance the customer service experience. Essential Functions Include: Assist call intake staff with call management and documentation of pharma and vaccine products as needed Conduct daily case processing of adverse event cases Case and event assessment Identify events and code using MedDRA Determine seriousness and expectedness of each event Perform assessment review and capture causality Conduct follow-up calls and prepare written communications to obtain follow-up information MedWatch, CIOMS, E2B Preparation Write case narratives and review MedWatch/CIOMS/E2B forms Provide signal detection analysis within aggregate reports Perform in-line case QC review Address client questions on case management and processes Complete client notifications as required for case management Develop training materials and conduct training presentations for staff Other duties as assigned Qualified candidates must have: RN, RPh, or PharmD, DVM or equivalent or life science degree Current healthcare license for degree or equivalent 2-3 years’ experience working in Pharmacovigilance Experience in a Case processing role within a Consultancy or Service provider is highly desirable Proficient with Microsoft Office Suite (Outlook, Word, Excel) Understanding of the legal, regulatory, and pharmacovigilance environment within the pharmaceutical industry Excellent internal and external customer service skills Strong verbal, written, and interpersonal communication skills Excellent attention to detail Strong organization, prioritization, project management, and delegation skills Able to work independently and collaboratively in a multidisciplinary team Able to occasionally work extended and/or flexible schedules to meet client requirements Additional Information We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits.
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The Senior Pharmacovigilance Specialist, Case Processing is tasked with managing pharmacovigilance cases through call intake, documentation, and case processing. This will entail performing the initial assessment of seriousness, expectedness, causality, and reportability of adverse events. In addition, you will also write accurate and complete narratives, report cases in accordance with internal guidelines, SOPs, and Global safety regulations. The role will also require performing case quality checks and signal detection activities and may act as client contact for case management and reporting functions. Ideally, you will proactively maintain a distinctive quality and commitment approach as the operating philosophy in carrying out all processes and will continually seek out ways to enhance the customer service experience. Essential Functions Include: Assist call intake staff with call management and documentation of pharma and vaccine products as needed Conduct daily case processing of adverse event cases Case and event assessment Identify events and code using MedDRA Determine seriousness and expectedness of each event Perform assessment review and capture causality Conduct follow-up calls and prepare written communications to obtain follow-up information MedWatch, CIOMS, E2B Preparation Write case narratives and review MedWatch/CIOMS/E2B forms Provide signal detection analysis within aggregate reports Perform in-line case QC review Address client questions on case management and processes Complete client notifications as required for case management Develop training materials and conduct training presentations for staff Other duties as assigned Qualified candidates must have: RN, RPh, or PharmD, DVM or equivalent or life science degree Current healthcare license for degree or equivalent 2-3 years’ experience working in Pharmacovigilance Experience in a Case processing role within a Consultancy or Service provider is highly desirable Proficient with Microsoft Office Suite (Outlook, Word, Excel) Understanding of the legal, regulatory, and pharmacovigilance environment within the pharmaceutical industry Excellent internal and external customer service skills Strong verbal, written, and interpersonal communication skills Excellent attention to detail Strong organization, prioritization, project management, and delegation skills Able to work independently and collaboratively in a multidisciplinary team Able to occasionally work extended and/or flexible schedules to meet client requirements Additional Information We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits.
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