Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
We are seeking an experienced, high caliber Clinical Safety Specialist II. The Safety Specialist II will work under the direction of the Safety Manager, Global Clinical Operations 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.
Impact this role will have at Abbott: -
Processes all adverse events per Work Instruction/ Protocol, working collaboratively with study specific CRAs to ensure comprehensive information is available for full review and reporting - Collaborates with Safety team members in preparation for DMC/DSMB/CEC meetings - Oversees weekly review of adverse events with applicable study teams. Reviews all adverse events in accordance with the specified Clinical Investigation Plan (CIP) - Codes adverse events where directed by the governing processes. Drafts AE narratives, as required, for inclusion in all FDA report submissions - Works with clinical study teams to ensure adherence to protocol, regulations and SJM policies regarding the reporting of adverse events - Maintains knowledge of current FDA, ICH, and ISO regulatory rules and policies affecting CVD Clinical study related products - Assists 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 - Assists with revision or writing of SOP/Instructions/Procedures and changes to support clinical department - Assists in development of study specific case report forms - Assists in clinical study protocol development - Assists with BIMO audits, when directed. Collaborates on additional Clinical Research activities
Your experience(s), education and knowledge will further expand Abbott's marketplace success: -
Bachelor's degree in an area of science or RN - Strong understanding of adverse events and risk assessment - One of the following: - 2-3 years' experience within pharmacovigilance or medical device safety; - 3+ years' experience in medical device or Pharma in clinical research or risk assessment - Working knowledge of medical terminology, clinical research conduct, laws, regulations, and standards - Proficient in MS Office and database navigation skills - Strong interpersonal and communication skills - Excellent record keeping, organizational skills, and problem solving abilities - Highly motivated and capable of working independently and as a team member - Experience coordinating, prioritizing, and setting timelines for multiple tasks - Ability to multi-task and adapt to a rapid pace environment - Strong technical writing skills
Your preferred qualifications and education: --
-2-3 years of experience in a hospital or clinic setting, preferably within the cardiovascular arena ---Master's degree or MD
JOB FAMILY:Medical & Scientific Affairs
DIVISION:MD Medical Devices
LOCATION:United States > Santa Clara : Building A - SC Floor-2
TRAVEL:Yes, 5 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
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