Abbott Medical Safety Monitor in Santa Clara, California
At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
The Medical Safety Monitor is responsible for the oversight of the adverse events and product experiences reported within a clinical trial. The Medical Safety Monitor ensures the appropriate reporting of the events to the Clinical Development Department and applicable Regulatory Authorities throughout the life of the trial. The Medical Safety Monitor acts as the liaison between the Safety department and all other internal departments as well as to external customers such as CROs, Clinical Events Committees and Data Safety Monitoring Boards associated to the trial.
Participates in protocol review for safety input such as requirement of a CEC or DSMB, adverse event reporting requirements and endpoint determination.
· Participates in the formulation of case report forms, specifically with regards to reporting and management of adverse events.
· Assists with all activities related to establishing and managing all safety-related processes.
· Participate in vendor selection for DSMB, CEC and Safety outsourcing activities
· Reviews all safety related data for various clinical trials.
· Reviews clinical safety databases. creating narrative reports for notable clinical events. assisting sites with subject evaluation and protocol adherence. and preparing safety reports to support regulatory notifications and filings.
· Serve as the main liaison between the different bodies involved in the safety process i.e. between the DSMB, CEC, CRO, investigators, and study team.
· Lead safety work in an outsourced model with different safety responsibilities allocated to multiple organizations
· Support preparation of periodic safety reports to the FDA and IRB/IECs.
· Support preparation of safety section of clinical study reports, Clinical Expert reviews, clinical section of device reports, and other ad hoc reports documents as needed to support formal (PMA) regulatory filings.
· Assist in formulating and implementing guidelines and processes in establishing independent safety monitoring boards and committees for clinical trials.
· Develop, coordinate and complete clinical study safety training for all staff involved with clinical study.
Will report to the Associate Director of Safety. · Is responsible to support the budget goals of the safety department but not directly responsible for budgeting activities. · Will have internal contact with applicable departments in regards to the activities of the clinical trial(s). · Will have external contact with applicable committees (e.g., CEC, DSMB & CROs) in regards to the activities of the clinical trial(s).
Bachelor’s degree or equivalent combination of education and experience. Masters, M.D., PH.D., RN, BSN, Nurse Practitioner or Physician Assistant degree (or the equivalent work experience) strongly preferred. Employee must have a strong clinical orientation and knowledge of diverse therapeutic categories. Minimum of 5-7 years of clinical research experience, preferably at least three years in medical safety and one year in medical devices. Direct patient care is strongly preferred. Adequate knowledge in reviewing, interpreting and reporting medical records.
· Adequate knowledge in reviewing and interpreting medical diagnostic tests.
· Excellent verbal and written communication skills
· Excellent negotiation and presentation skills
· Knowledge of FDA and ICH
· Regulations/Guidelines governing the reporting of adverse events strongly preferred.
· Experience using relational database applications for clinical trial management and safety management
· Experience in participating in safety review processes.
· Experience in participating in the conduct of clinical trials.
· Familiar with medical terminology and MedDRA
· Organizational skills & ability to direct and manage projects.
· Ability to manage multiple priorities · Analytical, detail-oriented, and with ability to solve problems and multi-task.
Clinical Affairs / Statistics
United States > Santa Clara : Building A - SC Floor-2
Yes, 15 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
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Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
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