Drug Safety Public Health Coordinator
Hays

Job Info

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The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

A Biotechnology Company is seeking a Drug Safety Public Health Coordinator in Foster City, CA.

Role Description

• Operations 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. 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 Responsible for regulatory submissions of ICSR and aggregate reports. Assist with tracking and reconciliation of incoming adverse event reports, Investigator letter distribution, and regulatory submissions. 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 Ensures compliance with SDEA and other global regulatory reporting requirements for ICSR 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.

Skills & Requirements

• Excellent interpersonal and 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 Understanding of medical terminology and the ability to summarize medical information is preferred The ability to assess data and understand the medical/safety implications.
• 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 Self-motivated and capable of working independently.
• Understands safety database structures and is familiar with data retrieval tools.
• Case processing experience is preferred Knowledge of clinical trials activities preferred Medical Safety Coding (MSC) Entry level, participates in initial period of training under direct supervision of manager, and then works under minimal supervision.
• Supports MSC Coding Group and assists in coding of adverse event and medication terms for clinical and post-marketing data using the MedDRA and WHO Drug coding dictionaries, and collaborates with Clinical Data Management (CDM) to assist in timely completion of coding jobs.
• Provides functional group administrative support and assists in other projects as needed.
• Assists in quality control of document archives and contributes to improvement of established processes.
• Demonstrates proficiency in verbal and email communication, including Microsoft Excel, Word, and Power Point.
• Demonstrates excellent attention to detail, teamwork and initiative; maintains confidentiality.
• Contributes toward completion of organizational projects and goals, and maintains meticulous attention to project deadlines
• Demonstrates extensive knowledge in a specialized function, and a wide and comprehensive knowledge of both general and specific aspects of the job and their practical application to complex problems and situations.
• Recognizes and seeks interdepartmental assistance for missing data; interdepartmental contacts are frequent and involve planning and preparation of communications.

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.

Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.

• Medical
• Dental
• Vision
• 401K
• Life Insurance ($20,000 benefit)

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Hays is an Equal Opportunity Employer including disability/veteran.

In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570

Drug testing may be required; please contact a recruiter for more information. #1148164

This job has expired.