Abbott Clinical Safety Specialist II in Plymouth, Minnesota
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.
Job Summary :
Collaborates with other members of the Medical Safety team to provide support to internal functional teams including Clinical, Quality, Reliability, Regulatory Compliance and Data Management. He/she will also interact with external customers, including expert physicians, members of different advisory boards. The Medical Safety Specialist will work under the direction of the Medical Safety Manager, Medical/Scientific Affairs processing adverse events as defined per clinical protocols. This role will also assist with the education of clinical teams on identification and reporting of adverse events specific to clinical research projects. Employees act on their strong desire to make a difference, partner with others and put ideas into action. Employees are engaged by a work culture that is team oriented, fast paced and progressive.
Job Duties :
• Contribute to the development and implementation of safety program initiatives, process improvements, and sound safety principles and practices.
• Process all adverse events per Work Instruction / Protocol, working collaboratively with study specific CRAs to ensure comprehensive information is available for advisory committee review and reporting.
• Work with clinical study teams to ensure adherence to protocol, regulations and SJM policies regarding the reporting of adverse events.
• Assist with training on study specific adverse event definitions prior to start of clinical study/registry and ongoing as needed to insure compliance and accurate reporting.
• Participate as a member of the team to support clinical expert panels (DMC/DSMB/CEC), including assisting in the preparation of briefing documents, organizing meetings and preparing meeting minutes.
• Contributes in the development and writing of industry standard operating procedures and processes for safety activities including writing of the Safety Management Plan for assigned studies to ensure the uniform and timely processing of adverse event reports.
• Assist in responding to queries from regulatory authorities or outside sources; compiling and supplying as requested, safety information for Regulatory submissions such as IDE (Investigational Device Exemption), Progress reports, Final reports and PMAs.
• Ensures departmental workflow processes and timelines are followed.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities, on occasion, as assigned.
A Bachelor degree from an accredited university or college. Preferably with an
academic focus in natural science, pre-medicine, nursing, bioengineering, or a
related academic field.
• Working knowledge of medical terminology, clinical research conduct, regulations, and standards.
• Excellent interpersonal, communication, and personal organization skills; ability to prioritize workload and work effectively, sometimes within resource constraints.
• Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation, worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.
• Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, and experience with regulatory submissions.
• Experience in Clinical studies conduct and management.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment
• Prefer an advanced degree in Pharmacy, Nursing, Life Science, or other health-related field
• Preferably 3-5 years of experience in a hospital or clinic setting, within the cardiovascular or neurology specialties.
Medical & Scientific Affairs
ASJM Abbott St. Jude Medical
United States > Minnesota : 5050 Nathan Lane N.
United States > Sunnyvale : 645 Almanor Ave
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
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
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
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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