Medical Safety Monitor

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 113,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

For years, Abbott's MEDICAL DEVICES businesses have offered technologies that are faster, more effective, and less invasive. Whether it's glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine finger sticks.

WHAT YOU'LL DO:

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.

Main Responsibilities

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.

Accountability

Will report to the senior manger 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).

EDUCATION & EXPERIENCE YOU'LL BRING:

Bachelors 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.

WHAT WE OFFER:

At Abbott, you can have a good job that can grow into a great career. We offer:

• Training and career development, with onboarding programs for new employees and tuition assistance

• Financial security through competitive compensation, incentives and retirement plans

• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

• Paid time off

• 401(k) retirement savings with a generous company match

• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal

JOB FAMILY:
Clinical Affairs / Statistics

DIVISION:
MD Medical Devices

LOCATION:
United States > Maple Grove : 6820 Wedgwood Road N.

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Not specified

MEDICAL SURVEILLANCE:
Not Applicable

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

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf