Entry level - Drug Safety

divh2Entry Level - Drug Safety/h2pSets work priorities and direction with input from Manager./ppResponsible for the accurate and timely book-in and acknowledgement of adverse event information in compliance with applicable SOPs and guidelines./ppUnderstand SDEA and global regulatory reporting timelines in order to prioritize cases if needed./ppPerform simple queries of the safety database, e.g. duplicate searches./ppMaintain and manage dept. Safety mailbox, distributing to relevant parties as applicable./ppMay perform initial data entry of ICSRs (review, extract, accurately enter AE data from ICSR reports)./ppMay interpret case-related information including medical conditions, lab results and procedures, as well as compile complete narrative summaries./ppMeet specific data and quality targets for case handling/ppAssist with tracking and reconciliation of incoming adverse event reports./ppCoordinate submission of product complaints to the Quality assurance department./ppParticipate in department projects, as required and will be cross-trained to handle other functions as deemed necessary/ppRecognizes situations that require assistance from more senior staff members and seeks assistance from appropriate internal and external resources./ppAssists Safety Specialists in sending and tracking follow-up letters./ppRemain current with case handling SOPs, guidance documents and database technology/ppMay assist manager in the preparation of training material and assist in training new employees their functional area./ppMay assist manager with writing/reviewing guidelines for their functional area of expertise./ppMay assist with other projects as necessary (i.e., study unbinding, reconciliation with vendors, etc)/ppEnsures departmental workflow processes and timelines are followed/ppExcellent interpersonal communication skills, both written and oral/ppExcellent computer skills in Microsoft environment (Microsoft Excel, Power point and Word)./ppSafety database and data entry experience preferred/ppBasic understanding of medical and drug terminology preferred/ppKnowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations is preferred/ppDemonstrates initiative, teamwork and accountability/ppDemonstrated success working both independently and in collaboration with others/ppA quality driven individual with strong attention to detail and accuracy is required/ppStrong organizational skills, and ability to adapt to change/ppA demonstrated ability to manage own workload, prioritize, plan and organize assignments and work under stick timelines is required./ppAbility to follow guidelines and procedural documents/ppAA or BS degree (or equivalent experience) and little to no experience./ppIndustry experience in the health, clinical, bio-pharmaceutical, or relevant industries such as, pharmacy technician, nursing assistant is valuable but not required./ppAll your information will be kept confidential according to EEO guidelines./p/div

Careers Integrated Resources Inc