· 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

· 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.

Rupalim Dutta
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I

DIRECT # 650-399-0896
LinkedIn: www.linkedin.com/in/rupalim-dutta