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Safety Public Health Specialist Ã?????????????Ã????????????Ã?????

Kelly Scientific Resources Foster City Full-Time
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Safety Public Health Specialist – II Description: Systems Must be proficient in written and verbal communication. Contributes to full life cycle of safety data retrieval activities data query, authoring, validation and publishing reports. Executes validation protocols. Demonstrates attention to detail, teamwork and initiative. Understands relational databases and reporting tools. Sets work priorities and direction with input from manager. Knowledge of computer systems, data processing, and enterprise software applications. Technical experience with computer systems, databases, and end user support. Good working knowledge skills with Microsoft Office Products, Microsoft Visio, and Microsoft Project. Understands current regulations within drug safety Operations Sets work priorities and direction with input from Manager. Review, extract and accurately enter AE data from ICSR reports from both investigational and post marketing products. Interpret case-related information including medical conditions, lab results and procedures, as well as compile complete narrative summaries. Review, enter, and verify follow-up information for cases and make accurate determination of significant information Performs review of ancillary documentation accompanying ICSR reports and identifies pertinent information for incorporations into the case narrative Correctly identify cases requiring targeted follow-up, determine relevant follow-up required and prepare follow-up queries. Have solid working knowledge of protocol design and details relating to the extraction and entry of SAE from clinical trials reports Will have data review responsibility, to ensure data entries made by Safety Coordinators are accurate. Will interact with other Drug Safety functional areas to process adverse events efficiently and reliably. Will liaise with clinical department, affiliate, marketing or contract research organizations as needed on safety data issues i.e., obtaining clarification or follow-up information . Identifies issues/concerns in a timely and appropriate manner Meet specific data and quality targets for case handling Remain current with case handling SOPs, guidance documents and database technology Organizes workload to ensure compliance with SDEA and other global regulatory reporting requirements for ICSR. Demonstrates general understanding of appropriate labeling documents for Gilead products. Ensures departmental workflow processes and timelines are followed Works with Submissions Team to properly identify global regulatory reporting requirements especially for Gilead sponsored clinical trials reports May assist manager in the preparation of training material and assist in training new employees May assist with other projects as necessary (i.e., study unblinding). Perform clinical trial reconciliation with minimal supervision from Manager or Sr Safety Specialist Identify cases requiring investigator letters and draft investigator letters with minimal supervision from Manager or Sr Safety Specialist May triage and assign the incoming reports. Acts as a trainer and mentor for more junior staff members. Participate in some clinical trial activities with supervision from Manager or Sr Safety Specialist (i.e., protocol & CRF reviews, data management plan reviews, CRO agreements & flows) May participates in Study Management Teams (as applicable) May assists in the development of drug safety presentation for investigator meeting presentations. Qualifications 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 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 strict 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) Works independently with little or no supervision. Supports MSC Coding Group if assigned and ensures 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 ensure timely completion of coding jobs. Maintains metrics log of MSC document reviews or coding jobs. Generates reports from internal safety or coding database. Provides functional group administrative support and assists in other projects as needed. 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. Recognizes and seeks interdepartmental assistance for missing data. Interdepartmental contacts are frequent and involve planning and preparation of communications, along with skill, tact, persuasion, and/or negotiation to accomplish.





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With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations— providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.



About Kelly Services®


As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit URL blocked - click to apply and connect with us on URL blocked - click to apply, URL blocked - click to apply and URL blocked - click to apply.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. URL blocked - click to apply

 

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Job ID: US15TPCC_BH1563424

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In a recent study, one-third of large companies predicted contingent workforce growth of 50 percent or more.* Kelly Scientific Resources® can help you be a part of this contingent workforce growth opportunity.

Kelly Scientific Resources is a specialty service of Kelly Services®. As the world's largest provider of HR solutions to the scientific community, Kelly Scientific Resources is focused exclusively on placing skilled scientific professionals in contract, contract-to-hire, and full-time science jobs across a full spectrum of related industries and disciplines, including:

  • Biomedical
  • Biotechnology
  • Chemical
  • Clinical Trials / Clinical
  • Clinical Research
  • Consumer Products
  • Cosmetics
  • Drug Discovery and Safety
  • Environmental Health
  • Food Science
  • Health Physics
  • Laboratory
  • Pharmaceutical
  • Production and Manufacturing
  • Quality Assurance and Control
  • Research and Development

Kelly Scientific Resources employees work more than 7 million hours in positions ranging from clinical research associates to molecular biologists to biochemists—from entry level to Ph.D.

It all began when William R. Kelly—founder of the temporary staffing industry—established Kelly Services® in 1946. The company's traditional expertise started with office services, call center, light industrial, and electronic assembly staffing. Through the years, we expanded our expertise and established a proven record of successfully matching job seekers to opportunities in disciplines such as science, engineering, law, education, healthcare, IT, and finance. As a Fortune 500® company, Kelly® has evolved into a global workforce solutions leader, making employment connections for nearly half a million people around the world every year.

Since our founding, we have embodied the true spirit of social responsibility. Our character and values resonate through our culture. Inherently—through our core business focus—we seek to improve the quality of life for our employees, their families, and their communities, as well as society at large. We embrace the role we play and the value we contribute to society—whether ensuring equal opportunity to employment, promoting safer workplace conditions, advocating for healthcare reform, or adhering to sustainable business practices.

Together with our employees and our customers, we will continue to work toward ensuring that our legacy will remain strong for generations to come. For more than 60 years, people have trusted Kelly Services to help them reach their career goals. We are your proven link to employment opportunities that will pave the way for a successful future. Whoever and wherever you are—and with the right skills and attitude—Kelly can help you find a job, expand your career, and build your future.

*According to “The Emerging New Workforce,” a 2009 report by Littler Mendelson, P.C., an employment and Labor Law solution firm.

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