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Entry level - Drug Safety

Integrated Resources, Inc

Foster City, California

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JOB DETAILS
JOB TYPE
Contractor
SKILLS
Adverse Events, Biotech and Pharmaceutical, Clinical Laboratory, Communication Skills, Computer Skills, Data Entry, Database Technology, Detail Oriented, Drug Terminology, Establish Priorities, International News, Interpersonal Skills, Laboratory Techniques, Medical Conditions, Medical Records, Medical Terminology, Microsoft Excel, Microsoft PowerPoint, Microsoft Product Family, Microsoft Word, Nursing, Organizational Skills, Pharmacovigilance, Pharmacy, Public Health, Public Safety, Quality Assurance, Reconciliation, Regulatory Compliance, Regulatory Reports, Safety/Work Safety, Staff Training, Standard Operating Procedures (SOP), Team Player, Technical Leadership, Time Management, Writing Skills
LOCATION
Foster City, California
POSTED
1 day ago
Entry Level - Drug SafetySets work priorities and direction with input from Manager.Responsible for the accurate and timely book-in and acknowledgement of adverse event information in compliance with applicable SOPs and guidelines.Understand SDEA and global regulatory reporting timelines in order to prioritize cases if needed.Perform simple queries of the safety database, e.g. duplicate searches.Maintain and manage dept. Safety mailbox, distributing to relevant parties as applicable.May perform initial data entry of ICSRs (review, extract, accurately enter AE data from ICSR reports).May interpret case-related information including medical conditions, lab results and procedures, as well as compile complete narrative summaries.Meet specific data and quality targets for case handlingAssist with tracking and reconciliation of incoming adverse event reports.Coordinate submission of product complaints to the Quality assurance department.Participate in department projects, as required and will be cross-trained to handle other functions as deemed necessaryRecognizes situations that require assistance from more senior staff members and seeks assistance from appropriate internal and external resources.Assists Safety Specialists in sending and tracking follow-up letters.Remain current with case handling SOPs, guidance documents and database technologyMay assist manager in the preparation of training material and assist in training new employees their functional area.May assist manager with writing/reviewing guidelines for their functional area of expertise.May assist with other projects as necessary (i.e., study unbinding, reconciliation with vendors, etc)Ensures departmental workflow processes and timelines are followedKnowledge, Experience and Skills:Excellent interpersonal communication skills, both written and oralExcellent computer skills in Microsoft environment (Microsoft Excel, Power point and Word).Safety database and data entry experience preferredBasic understanding of medical and drug terminology preferredJD – Drug Safety & Public Health, OperationsKnowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations is preferredDemonstrates initiative, teamwork and accountabilityDemonstrated success working both independently and in collaboration with othersA quality driven individual with strong attention to detail and accuracy is requiredStrong organizational skills, and ability to adapt to changeA demonstrated ability to manage own workload, prioritize, plan and organize assignments and work under stick timelines is required.Ability to follow guidelines and procedural documentsAA or BS degree (or equivalent experience) and little to no experience.Industry experience in the health, clinical, bio-pharmaceutical, or relevant industries such as, pharmacy technician, nursing assistant is valuable but not required.

About the Company

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Integrated Resources, Inc