Responsible for 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 as needed.
Requirements :
Required: a Bachelor's degree in life sciences.
Preferred: advanced degree, RN, RPh, PharmD or equivalent.
Strong verbal, written and interpersonal communication skills.
High level of accuracy and attention to detail.
Ability to identify and resolve problems in a timely manner.
Able to work independently and collaboratively in a multi-disciplinary team.
Excellent organization and prioritization skills; able to multitask.
Basic knowledge of Pharmacovigilance.
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