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 114000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
Supervisor Medical Events
Working at Abbott
At Abbott you can do work that matters grow and learn care for yourself and your family be your true self and live a full life. Youll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.
- An excellent retirement savings plan with a high employer contribution
- Tuition reimbursement the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelors degree.
- A company recognized as a great place to work in dozens of countries worldwide 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 the best place to work for diversity working mothers female executives and scientists.
The Opportunity
This position works out of our Alameda CA location in the Diabetes Care division where were focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. Were 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.
This position will be based out of our Abbott Diabetes Care in Alameda CA and the individual will be expected to be onsite Monday-Friday.
What Youll Work On
- Responsible 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 matter 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.
- Assists the Medical Events Group Associate Director in performance evaluations and administrative duties.
Required Qualifications
- Bachelors 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 Qualifications
- Demonstrates initiative problem-solving and critical-thinking skills. Strong written and verbal communication skills.
- Knowledge of FDA/International guidelines for drug/device safety reporting requirements.
Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:
Follow 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.
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Divisional Information
Medical Devices
General Medical Devices:
Our medical devices help more than 10000 people have healthier hearts improve quality of life for thousands of people living with chronic pain and movement disorders and liberate more than 500000 people with diabetes from routine ngersticks.
Diabetes
Were focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. Were revolutionizing the way people monitor their glucose levels with our new sensing technology.
The base pay for this position is
$98000.00 $196000.00
In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
ADC Diabetes Care
LOCATION:
United States > Alameda : 1360-1380 South Loop Road
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
MEDICAL SURVEILLANCE:
No
SIGNIFICANT 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)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: EEO is the Law link - Espanol: Experience:
Manager