Drug Safety Public Health Coordinator

Location: Foster City, California
Posted On: 6/8/2017
Job Code: DSPHC_CA_3249
Job Description
• 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 organization's 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
Category:Non-IT  code:new
Job Requirements
• Excellent interpersonal communication skills, both written and oral
• Excellent computer skills in MS environment (MS Excel, Power point and Word).
• Safety database and data entry experience preferred
• Basic understanding of medical and drug terminology
• 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 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.

If you are interested in the role then please revert with an updated resume in word format.

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Contact Details
Riya Jain
E-mail Address