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 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 followed
Knowledge, Experience and Skills:
Excellent interpersonal 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
JD – Drug Safety & Public Health, Operations
Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations is preferred
Demonstrates 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 stick 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.