1. JD – Drug Safety & Public Health, Operations
Confidential Page 1 March 2012
Safety Coordinator, Drug Safety & Public Health
Operations
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 Gilead 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

2. JD – Drug Safety & Public Health, Operations
Confidential Page 2 March 2012
 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.