Fiscal Year

2021

Case Number

A-20300-13166

Case Status

Certified

Received Date

2020-12-17

Decision Date

2021-06-10

Refile

N

Original File Date

2021-01-01 09:35:32

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

AMGEN INC.

Employer Name Slug

amgen-inc

Employer Address 1

ONE AMGEN CENTER DRIVE

Employer Address 2

Employer City

THOUSAND OAKS

Employer City Slug

thousand-oaks

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

91320

Employer Phone

805-447-1000

Employer Number of Employees

12973

Employer Year Commenced Business

1980

NAICS Code

54171

FW Ownership Interest

N

Employer Contact Name

Jenny Cummings

Employer Contact Address 1

2202 N. Westshore Blvd.

Employer Contact Address 2

Employer Contact City

Tampa

Employer Contact State/Province

FLORIDA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

33607

Employer Contact Phone

813-392-0428

Employer Contact Email

jen01@amgen.com

Agent Attorney Name

Laura Bloniarz

Agent Attorney Firm Name

Berry Appleman Leiden LLP

Agent Attorney Phone

469-290-9687

Agent Attorney Address 1

2400 N Glenville Drive, Building A

Agent Attorney Address 2

Suite 100

Agent Attorney City

Richardson

Agent Attorney State/Province

TEXAS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

75082

Agent Attorney Email

labloniarz@balglobal.com

PW Track Number

P10019284082607

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level IV

PW Wage

113006.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-02-10

PW Expiration Date

2020-06-30

Wage Offer From

113006.00

Wage Offer To

0.00

Average Salary

113006.00

Wage Unit of Pay

Year

Worksite Address 1

One Amgen Center Drive

Worksite Address 2

Worksite City

Thousand Oaks

Worksite City Slug

thousand-oaks

Worksite State

CALIFORNIA

Worksite Postal Code

91320

Job Title

Senior Associate Pharmacovigilance Operations

Job Title Slug

senior-associate-pharmacovigilance-operations

Minimum Education

Bachelor's

Major Field of Study

See H.14

Required Training

N

Required Experience

Y

Required Experience Months

60

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

Y

Accept Alternative Combination Education

Master's

Accept Alternative Combination Education Years

2

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

60

Accept Alternative Job Title

See H.14

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

BACHELORS DEGREE IN HEALTHCARE ADMINISTRATION, BIOTECHNOLOGY, PHARMACY, OR A RELATED FIELD PLUS 5 YEARS OF PROGRESSIVE POST BACH EXPERIENCE IN PROCESSING INDIVIDUAL CASE SAFETY REPORTS TO ENSURE HIGH QUALITY CASES PRODUCED IN A TIMELY MANNER TO MEET ALL WORLDWIDE REGULATORY AUTHORITY REQUIREMENTS; REVIEWING CLINICAL AND POST MARKET ADVERSE EVENT, PRODUCT COMPLAINT AND OTHER SAFETY FINDING CASES; FOLLOWING UP ON ADVERSE EVENT REPORTS AND INQUIRIES FROM PHYSICIANS, PATIENTS, AND PHARMACIES; SUPPORTING THE DEVELOPMENT AND DELIVERY OF CONVENTIONRELATED TRAINING MATERIAL; REVIEWING AND RESPONDING TO ADVERSE EVENT INTAKE, TRIAGE, AND SUBMISSION QUERIES IN A TIMELY FASHION; AND MANAGING UNBLINDING CASES, INCLUDING MONITORING UNBLINDING MAILBOX FOR UNBLINDING REQUESTS FROM MEDICAL SAFETY TEAM AND CASE PROCESSORS, CONFIRMING THE NEED FOR UNBLINDING FOR THE REQUESTED CASES, CHECKING IN SAFETY DATABASE WHETHER A PATIENT WAS GIVEN DRUG OR PLACEBO, PERFORMING DATA ENTRY INTO THE ARGUS DATABASE.br OR MASTERS DEGREE IN HEALTHCARE ADMINISTRATION, BIOTECHNOLOGY, PHARMACY, OR A RELATED FIELD PLUS 2 YEARS OF EXPERIENCE IN PROCESSING INDIVIDUAL CASE SAFETY REPORTS TO ENSURE HIGH QUALITY CASES PRODUCED IN A TIMELY MANNER TO MEET ALL WORLDWIDE REGULATORY AUTHORITY REQUIREMENTS; REVIEWING CLINICAL AND POST MARKET ADVERSE EVENT, PRODUCT COMPLAINT AND OTHER SAFETY FINDING CASES; FOLLOWING UP ON ADVERSE EVENT REPORTS AND INQUIRIES FROM PHYSICIANS, PATIENTS, AND PHARMACIES; SUPPORTING THE DEVELOPMENT AND DELIVERY OF CONVENTIONRELATED TRAINING MATERIAL; REVIEWING AND RESPONDING TO ADVERSE EVENT INTAKE, TRIAGE, AND SUBMISSION QUERIES IN A TIMELY FASHION; AND MANAGING UNBLINDING CASES, INCLUDING MONITORING UNBLINDING MAILBOX FOR UNBLINDING REQUESTS FROM MEDICAL SAFETY TEAM AND CASE PROCESSORS, CONFIRMING THE NEED FOR UNBLINDING FOR THE REQUESTED CASES, CHECKING IN SAFETY DATABASE WHETHER A PATIENT WAS GIVEN DRUG OR PLACEBO, PERFORMING DATA ENTRY INTO THE ARGUS DATABASE.br br Any suitable combination of education, training, or experience is acceptable.

Combination Occupation

N

Offered to Applicant Foreign Worker

Y

Foreign Worker Live on Premises

N

Foreign Worker Live in Domestic Service

N

Foreign Worker Live in Domestic Service Count

Professional Occupation

Y

Application for College/University Teacher

N

SWA Job Order Start Date

2020-06-30

SWA Job Order End Date

2020-07-30

Sunday Edition Newspaper

Y

First Newspaper Name

Los Angeles Daily News

First Advertisement Start Date

2020-07-12

Second Newspaper Ad Name

Los Angeles Daily News

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-07-19

Employer Website From Date

2021-01-01 09:35:32

Employer Website To Date

2021-01-01 09:35:32

Professional Organization Ad From Date

2020-07-08

Professional Organization Advertisement To Date

2020-07-15

Job Search Website From Date

2020-07-08

Job Search Website To Date

2020-07-15

Employee Referral Program From Date

2021-01-01 09:35:32

Employee Referral Program To Date

2021-01-01 09:35:32

Local Ethnic Paper From Date

2020-07-20

Local Ethnic Paper To Date

2020-07-20

Radio/TV Ad From Date

2021-01-01 09:35:32

Radio/TV Ad To Date

2021-01-01 09:35:32

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

INDIA

Foreign Worker Birth Country

INDIA

Class of Admission

H-1B

Foreign Worker Education

Master's

Foreign Worker Information: Major

HEALTH CARE ADMINISTRATION

Foreign Worker Years of Education Completed

2017

Foreign Worker Institution of Education

CALIFORNIA STATE UNIVERSITY, LONG BEACH

Foreign Worker Education Institution Address 1

1250 BELLFLOWER BLVD.

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

LONG BEACH

Foreign Worker Education Institution State/Province

CA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

90840

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Laura Bloniarz

Preparer Title

Sr. Associate Immigration Attorney

Preparer Email

labloniarz@balglobal.com

Employer Information Declaration Name

Jen Cummings

Employer Information Declaration Title

HR Representative