Fiscal Year

2023

Case Number

A-21350-87376

Case Status

Certified

Received Date

2022-03-07

Decision Date

2022-11-17

Refile

N

Original File Date

2023-01-01 18:10:22

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

svialva@fragomen.com

PW Track Number

P10021203478991

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level I

PW Wage

51251.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-01-06

PW Expiration Date

2022-06-30

Wage Offer From

104811.00

Wage Offer To

0.00

Average Salary

104811.00

Wage Unit of Pay

Year

Worksite Address 1

1800 Concord Pike

Worksite Address 2

Worksite City

Wilmington

Worksite City Slug

wilmington

Worksite State

DELAWARE

Worksite Postal Code

19850

Job Title

Patient Safety Specialist

Job Title Slug

patient-safety-specialist

Minimum Education

Bachelor's

Major Field of Study

Biosciences, Chemistry, Pharmacy or a related field

Required Training

N

Required Experience

Y

Required Experience Months

24

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

24

Accept Alternative Job Title

Pharmacovigilance Specialist or a related position in the Healthcare or Pharmaceutical industry

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Must have a Bachelors degree or foreign equivalent in Biosciences, Chemistry, Pharmacy, or a related field of study plus two 2 years of experience in the offered role, as a Pharmacovigilance Specialist, or a related position in the Healthcare or Pharmaceutical industry. Must have at least two 2 years of experience within the healthcare or pharmaceutical industry with Pharmacovigilance practices, including FDA Investigational New Drug Application, Post marketing reporting of adverse drug experience, and Biological Products, other Health Authorities including EU Good Pharmacovigilance Practices Modules, and ICH regulatory requirements, guidance, and obligations; Pharmacovigilance experience with case handling including post marketing and clinical, compliance andor quality; Quality management systems including compliance data analysis, trend analysis, root cause analysis and CAPA mitigation plans; Utilizing Business Objects and Spotfire reports for data trend analysis; Creation and management of procedural documents; Continuous process improvement initiatives; Supporting internalexternal audits and regulatory inspections, including cGVP and cGCP for pharmacovigilance related inquiries; Providing analysis and trending of local and global compliance data for adverse event reporting data, supporting andor creating compliance dashboards and communicating compliance outputs to customers and leadership; Contributing to the quality management framework by conducting thorough investigations and documenting high quality incident reports into the quality management system in order to minimize future risks; and Coordinating the timely investigation of quality incidents, including late ICSR reporting, conducting risk assessments, analyzing trendspatterns within the data, root cause analysis and identifying corrective actions and preventative actions to minimize risk. Employer will accept a Masters or PhD degree in a stated field in lieu of a Bachelors degree. Pre or post MastersPhD degree experience acceptable. 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

2021-12-21

SWA Job Order End Date

2022-01-21

Sunday Edition Newspaper

Y

First Newspaper Name

Wilmington News Journal

First Advertisement Start Date

2021-12-12

Second Newspaper Ad Name

Wilmington News Journal

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-12-19

Employer Website From Date

2021-11-11

Employer Website To Date

2022-01-10

Professional Organization Ad From Date

2023-01-01 18:10:22

Professional Organization Advertisement To Date

2023-01-01 18:10:22

Job Search Website From Date

2021-12-15

Job Search Website To Date

2022-01-10

Employee Referral Program From Date

2021-09-30

Employee Referral Program To Date

2021-10-15

Local Ethnic Paper From Date

2021-12-17

Local Ethnic Paper To Date

2021-12-17

Radio/TV Ad From Date

2023-01-01 18:10:22

Radio/TV Ad To Date

2023-01-01 18:10:22

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

CHEMISTRY

Foreign Worker Years of Education Completed

2014

Foreign Worker Institution of Education

WESTERN KENTUCKY UNIVERSITY

Foreign Worker Education Institution Address 1

1906 COLLEGE HEIGHTS BLVD

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BOWLING GREEN

Foreign Worker Education Institution State/Province

KY

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

42101

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

svialva@Fragomen.com

Employer Information Declaration Name

Adriana Echeverri

Employer Information Declaration Title

International Experiences, Regional Lead