Fiscal Year

2024

Case Number

A-23109-30007

Case Status

Certified

Received Date

2023-05-10

Decision Date

2024-05-28

Refile

N

Original File Date

2024-01-01 01:27:11

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

CSL BEHRING

Employer Name Slug

csl-behring

Employer Address 1

1020 FIRST AVENUE

Employer Address 2

Employer City

KING OF PRUSSIA

Employer City Slug

king-of-prussia

Employer State

PENNSYLVANIA

Employer State Slug

pennsylvania

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

19406

Employer Phone

610-878

Employer Number of Employees

8495

Employer Year Commenced Business

1995

NAICS Code

32541

FW Ownership Interest

N

Employer Contact Name

Ryan J Fleming

Employer Contact Address 1

1020 First Avenue

Employer Contact Address 2

Employer Contact City

King of Prussia

Employer Contact State/Province

PENNSYLVANIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

19406

Employer Contact Phone

610-878-4376

Employer Contact Email

ryan.fleming@cslbehring.com

Agent Attorney Name

Tiffany C Wu

Agent Attorney Firm Name

Fragomen, Del Rey, Bernsen Loewy, LLP

Agent Attorney Phone

9492610209

Agent Attorney Address 1

18401 Von Karman Ave., Ste. 255

Agent Attorney Address 2

Agent Attorney City

Irvine

Agent Attorney State/Province

CALIFORNIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

92612

Agent Attorney Email

tchang@fragomen.com

PW Track Number

P10022032867036

PW SOC Code

13-1041.07

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

66414.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-09-26

PW Expiration Date

2023-06-30

Wage Offer From

66414.00

Wage Offer To

133900.00

Average Salary

100157.00

Wage Unit of Pay

Year

Worksite Address 1

1020 First Avenue

Worksite Address 2

Worksite City

King of Prussia

Worksite City Slug

king-of-prussia

Worksite State

PENNSYLVANIA

Worksite Postal Code

19406

Job Title

Manager, Pharmacovigilance Agreements (Regulatory Affairs Specialist)

Job Title Slug

manager-pharmacovigilance-agreements-regulatory-affairs-specialist

Minimum Education

Master's

Major Field of Study

Regulatory Affairs

Required Training

N

Required Experience

Y

Required Experience Months

24

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Pharmacy or related field

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

Experience in Pharmacovigilance, relevant clinical environment or other Pharmaceutical sciences

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Must possess expertiseknowledge sufficient to adequately perform the duties of the job being offered. Expertiseknowledge may be gained through employment experience or education. Such expertiseknowledge cannot be quantified by time. Required expertiseknowledge includesbr br Detailed knowledge of major aspects of Pharmacovigilance PV for the analysis of risk profiles arising from different kinds of PV business models.br Understanding of PV legislations and global regulatory aspects of Pharmacovigilance.br Knowledge of the PV relevant legislations, regulatory framework and standards.br Experience in major aspects of PV to evaluate possible safety issues that might arise from contractual arrangements and to perform riskbased maintenance of PVcontracts.br Understanding of business models and impact on PV accountability.br Understanding of crossfunctionalmatrix type of work teams including knowledge of local and global business processes and governance structures.br Knowledge of the principles of internal and external audits and inspections.br Technical skills with Document Management Systems and Contract Management System.br br The years of experience listed in H.6 and H.10 do not apply to the required skills listed in this section.br Employer will accept any suitable combination of education, training, or experience.

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

2022-12-22

SWA Job Order End Date

2023-01-30

Sunday Edition Newspaper

Y

First Newspaper Name

Philadelphia Inquirer

First Advertisement Start Date

2023-03-12

Second Newspaper Ad Name

Philadelphia Inquirer

Second Advertisement Type

Newspaper

Second Ad Start Date

2023-03-19

Employer Website From Date

2024-01-01 01:27:11

Employer Website To Date

2024-01-01 01:27:11

Professional Organization Ad From Date

2024-01-01 01:27:11

Professional Organization Advertisement To Date

2024-01-01 01:27:11

Job Search Website From Date

2023-03-12

Job Search Website To Date

2023-03-20

Employee Referral Program From Date

2022-12-22

Employee Referral Program To Date

2023-01-19

Local Ethnic Paper From Date

2023-03-19

Local Ethnic Paper To Date

2023-03-19

Radio/TV Ad From Date

2024-01-01 01:27:11

Radio/TV Ad To Date

2024-01-01 01:27:11

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

2015

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

360 HUNTINGTON AVENUE

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

Tiffany C Wu

Preparer Title

Senior Associate

Preparer Email

tchang@fragomen.com

Employer Information Declaration Name

Tonetta Parker

Employer Information Declaration Title

Global Mobility Partner