Fiscal Year

2022

Case Number

A-21153-94645

Case Status

Certified-Expired

Received Date

2021-07-21

Decision Date

2022-01-18

Refile

N

Original File Date

2022-01-01 10:46:37

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

ASTRAZENECA PHARMACEUTICALS LP

Employer Name Slug

astrazeneca-pharmaceuticals-lp

Employer Address 1

1800 CONCORD PIKE

Employer Address 2

Employer City

WILMINGTON

Employer City Slug

wilmington

Employer State

DELAWARE

Employer State Slug

delaware

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

19897

Employer Phone

302-886-3000

Employer Number of Employees

76100

Employer Year Commenced Business

1966

NAICS Code

32541

FW Ownership Interest

N

Employer Contact Name

Echeverri Adriana

Employer Contact Address 1

One MedImmune Way

Employer Contact Address 2

Employer Contact City

Gaithersburg

Employer Contact State/Province

MARYLAND

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

20878

Employer Contact Phone

301-398-0209

Employer Contact Email

adriana.echeverri@astrazeneca.com

Agent Attorney Name

Hyla K Rosenberg

Agent Attorney Firm Name

Fragomen, Del Rey, Bernsen Loewy LLP

Agent Attorney Phone

2126888555

Agent Attorney Address 1

1400 Broadway

Agent Attorney Address 2

Agent Attorney City

New York

Agent Attorney State/Province

NEW YORK

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

10018

Agent Attorney Email

ACharniauskaya@fragomen.com

PW Track Number

P10020346954451

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level III

PW Wage

89024.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-04-23

PW Expiration Date

2021-07-22

Wage Offer From

129189.14

Wage Offer To

0.00

Average Salary

129189.14

Wage Unit of Pay

Year

Worksite Address 1

101 Orchard Ridge Drive

Worksite Address 2

Worksite City

Gaithersburg

Worksite City Slug

gaithersburg

Worksite State

MARYLAND

Worksite Postal Code

20878

Job Title

Safety Scientist

Job Title Slug

safety-scientist

Minimum Education

Master's

Major Field of Study

Regulatory Affairs, Pharmacy or rel

Required Training

N

Required Experience

Y

Required Experience Months

36

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

N

Accept Alternative Combination Education

Accept Alternative Combination Education Years

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

36

Accept Alternative Job Title

Scientist, Validation Engineer or rel within patient safety or pharmaceutical industry

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

MUST HAVE A MASTERS DEGREE OR FOREIGN EQUIVALENT IN REGULATORY AFFAIRS, PHARMACY OR A RELATED FIELD PLUS THREE 3 YEARS OF EXPERIENCE IN THEbr POSITION OFFERED, AS A SCIENTIST, VALIDATION ENGINEER OR A RELATED POSITION WITHIN THE PATIENT SAFETY OR PHARMACEUTICAL INDUSTRY.br MUST HAVE THREE 3 YEARS OF EXPERIENCE IN THE PATIENT SAFETY OR PHARMACEUTICAL INDUSTRY IN EACH OF THE FOLLOWING WATERFALL AND AGILEbr METHODOLOGY FOR SOFTWARE DEVELOPMENT LIFE CYCLE; FDA 21 CFR PART 11ELECTRONIC RECORDS AND ESIGNATURES, 210, 211, ANNEX 11 REGULATIONS, GLOBAL QUALITY AND SAFETY REPORTING REGULATORY EXPECTATIONS INCLUDING AS GXP VALIDATION, ICH E2B R2R3HL7 STANDARDS, AND INDIVIDUAL CASE SAFETY REPORTING; DELIVERING VALIDATION STRATEGIES FOR GXP SYSTEMS INCLUDING EDMS, EQMS AND PHARMACOVIGILANCE SYSTEMS INCLUDING ARISG,br ARGUS SAFETY AND BESPOKE PV SYSTEM; DESIGN, DEPLOYMENT OF SOLUTIONS IN SUPPORT OF SAFETY IN THE CONTEXT OF PHARMACOVIGILANCE SYSTEMSbr INCLUDING ARISG, ARGUS SAFETY AND BESPOKE PV SYSTEM; PERFORM COMPUTER SYSTEM VALIDATION, TESTING AND TECHNICAL WRITING INCLUDING USERbr REQUIREMENTS, FUNCTIONAL REQUIREMENTS, RISK ASSESSMENTS, PART 11 AND ANNEX 11 REQUIREMENT ASSESSMENTS, PROCEDURAL CONTROLS, AND SOPbr PLANNING FORMS; AND TEST PROTOCOLS, INSTALLATION QUALIFICATION, OPERATIONAL QUALIFICATION, PERFORMANCE QUALIFICATION, CONFIGURATION REPORTS, TRACEABILITY MATRIX AND SUMMARY REPORTS FOR VARIOUS GXP SYSTEMS WITH STRICT ADHERENCE TO GAMP REGULATIONS.

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

2021-04-27

SWA Job Order End Date

2021-05-30

Sunday Edition Newspaper

Y

First Newspaper Name

The Washington Post

First Advertisement Start Date

2021-05-02

Second Newspaper Ad Name

The Washington Post

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-05-09

Employer Website From Date

2021-04-27

Employer Website To Date

2021-07-09

Professional Organization Ad From Date

2022-01-01 10:46:37

Professional Organization Advertisement To Date

2022-01-01 10:46:37

Job Search Website From Date

2021-05-02

Job Search Website To Date

2021-05-09

Employee Referral Program From Date

2022-01-01 10:46:37

Employee Referral Program To Date

2022-01-01 10:46:37

Local Ethnic Paper From Date

2021-05-05

Local Ethnic Paper To Date

2021-05-05

Radio/TV Ad From Date

2022-01-01 10:46:37

Radio/TV Ad To Date

2022-01-01 10:46:37

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

REGULATORY AFFAIRS FOR DRUGS, BIOLOGICS, AND MEDICAL DEVICES

Foreign Worker Years of Education Completed

2013

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

360 HUNTINGTON AVE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BOSTON

Foreign Worker Education Institution State/Province

MA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

2115

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Hyla K Rosenberg

Preparer Title

Partner

Preparer Email

ACharniauskaya@fragomen.com

Employer Information Declaration Name

Adriana Echeverri

Employer Information Declaration Title

Global Mobility Advisor