• 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.

All your information will be kept confidential according to EEO guidelines.