Job Description :
Specific Responsibilities:
? Safety Coordinator, DSPH Operations
Essential Duties and Functions:
? Sets 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 handling
? Assist 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 necessary
? Recognizes 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 technology
? May assist manager in the preparation of training material and assist in training new employees their functional area.
? May assist manager with writing/reviewing guideines for their functional area of expertise.
? May assist with other projects as necessary (i.e, study unblinding, reconciliation with vendors, etc)
? Ensures departmental workflow processes and timelines are followed
Knowledge, Experience and Skills:
? Excellent interepersonal communication skills, both written and oral
? Excellent computer skills in Microsoft environment (Microsoft Excel, Power point and Word
? Safety database and data entry experience preferred
? Basic understanding of medical and drug terminology preferred.
Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations is preferred
? Demontrates initiative, teamwork and accountability
? Demonstrated success working both independently and in collaboration with others
? A quality driven individual with strong attention to detail and accuracy is required
? Strong organizational skills, and ability to adapt to change
? A demonstrated ability to manage own workload, prioritize, plan and organize assignments and work under strick timelines is required.
? Ability to follow guidelines and procedural documents
? AA 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.