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
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.
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 o verall
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 – $190,900.00
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:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
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: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf#J-18808-Ljbffr
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
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.
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 o verall
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 – $190,900.00
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:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
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: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf#J-18808-Ljbffr