Abbott
Medical Events Supervisor
Abbott, Alameda, California, United States, 94501
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 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:
Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:Career development with an international company where you can grow the career you dream of.Free medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent retirement savings plan with high employer contributionTuition reimbursement, the
Freedom 2 Save
student debt program and
FreeU
education benefit - an affordable and convenient path to getting a bachelor’s degree.A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.The OpportunityThis position works out of our Alameda, CA location in the Diabetes Care division where we're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.As the Supervisor, Medical Events Group you will be responsible for providing direct supervision to individuals in the Medical Events Group (MEG). Supervision includes answering routine complaint handling questions from individuals in MEG, training, and monitoring complaint cases to ensure timely review, proper documentation, and on-time filing of vigilance reports globally. The role will work closely with Customer Service, Complaint Evaluations Group, and Complaints Investigation Group to ensure accurate documentation and timely filing of submissions.This role will ensure the Medical Events Group (MEG) is compliant with global medical device reporting regulations.What You’ll Work OnResponsible for supervising personnel who review potentially reportable complaints and file Vigilance Reports to Competent Authorities globally.Responsible for ensuring Vigilance Reports are completed and submitted in a timely manner in accordance to applicable procedures by the Medical Events Group staff.Responsible for working with Customer Service, Complaint Evaluations Group, and Complaints Investigation Group to ensure accurate documentation and timely filing of submissions.Responsible for providing subject matter expertise, guidance, and training to members of the Medical Events Group, as well as to other functional departments.Responsible for monitoring people and processes with an eye towards resolving issues and improving the efficiency of the medical events reporting process.Responsible for identifying any trends that are found during the medical event process and alerting management in a timely manner.Performs verification of vigilance reports, as well as verification of data compiled for metrics, risk evaluations, CAPAs and various other MEG related activities.Supports the Reportable Confirmed Malfunction List (RCML) process by running monthly reports and assists the Medical Events Group Section Manager in coordinating the associated cross-functional review activities.Assists the Medical Events Group Section Manager in performance evaluations and administrative duties.Required QualificationsBachelors Degree in Science, Medical (Physician, Nursing, Pharmacy) or equivalent in a technical discipline.Minimum 3 years of overall experience working in a quality related role, or equivalent time in clinical laboratory, medical, or nursing experience.Preferred QualificationsDemonstrates initiative, problem-solving, and critical-thinking skills. Strong written and verbal communication skills.Knowledge of FDA/International guidelines for drug/device safety reporting requirements.Apply Now* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:
www.abbottbenefits.comFollow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. 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.The base pay for this position is
$95,500.00 – $190,900.00In specific locations, the pay range may vary from the range posted.JOB FAMILY:
Regulatory OperationsDIVISION:
ADC Diabetes CareLOCATION:
United States > Alameda : 1360-1380 South Loop RoadADDITIONAL LOCATIONS:
WORK SHIFT:
StandardTRAVEL:
Not specifiedMEDICAL SURVEILLANCE:
Not ApplicableSIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
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Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:Career development with an international company where you can grow the career you dream of.Free medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent retirement savings plan with high employer contributionTuition reimbursement, the
Freedom 2 Save
student debt program and
FreeU
education benefit - an affordable and convenient path to getting a bachelor’s degree.A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.The OpportunityThis position works out of our Alameda, CA location in the Diabetes Care division where we're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.As the Supervisor, Medical Events Group you will be responsible for providing direct supervision to individuals in the Medical Events Group (MEG). Supervision includes answering routine complaint handling questions from individuals in MEG, training, and monitoring complaint cases to ensure timely review, proper documentation, and on-time filing of vigilance reports globally. The role will work closely with Customer Service, Complaint Evaluations Group, and Complaints Investigation Group to ensure accurate documentation and timely filing of submissions.This role will ensure the Medical Events Group (MEG) is compliant with global medical device reporting regulations.What You’ll Work OnResponsible for supervising personnel who review potentially reportable complaints and file Vigilance Reports to Competent Authorities globally.Responsible for ensuring Vigilance Reports are completed and submitted in a timely manner in accordance to applicable procedures by the Medical Events Group staff.Responsible for working with Customer Service, Complaint Evaluations Group, and Complaints Investigation Group to ensure accurate documentation and timely filing of submissions.Responsible for providing subject matter expertise, guidance, and training to members of the Medical Events Group, as well as to other functional departments.Responsible for monitoring people and processes with an eye towards resolving issues and improving the efficiency of the medical events reporting process.Responsible for identifying any trends that are found during the medical event process and alerting management in a timely manner.Performs verification of vigilance reports, as well as verification of data compiled for metrics, risk evaluations, CAPAs and various other MEG related activities.Supports the Reportable Confirmed Malfunction List (RCML) process by running monthly reports and assists the Medical Events Group Section Manager in coordinating the associated cross-functional review activities.Assists the Medical Events Group Section Manager in performance evaluations and administrative duties.Required QualificationsBachelors Degree in Science, Medical (Physician, Nursing, Pharmacy) or equivalent in a technical discipline.Minimum 3 years of overall experience working in a quality related role, or equivalent time in clinical laboratory, medical, or nursing experience.Preferred QualificationsDemonstrates initiative, problem-solving, and critical-thinking skills. Strong written and verbal communication skills.Knowledge of FDA/International guidelines for drug/device safety reporting requirements.Apply Now* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:
www.abbottbenefits.comFollow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. 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.The base pay for this position is
$95,500.00 – $190,900.00In specific locations, the pay range may vary from the range posted.JOB FAMILY:
Regulatory OperationsDIVISION:
ADC Diabetes CareLOCATION:
United States > Alameda : 1360-1380 South Loop RoadADDITIONAL LOCATIONS:
WORK SHIFT:
StandardTRAVEL:
Not specifiedMEDICAL SURVEILLANCE:
Not ApplicableSIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
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