Fiscal Year

2024

Case Number

A-23086-18671

Case Status

Certified

Received Date

2023-03-27

Decision Date

2024-04-12

Refile

N

Original File Date

2024-01-01 01:04:06

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

TAKEDA DEVELOPMENT CENTER AMERICAS, INC.

Employer Name Slug

takeda-development-center-americas-inc

Employer Address 1

95 HAYDEN AVE

Employer Address 2

Employer City

LEXINGTON

Employer City Slug

lexington

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

2421

Employer Phone

224-544-1749

Employer Number of Employees

19608

Employer Year Commenced Business

2003

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Ken Brown

Employer Contact Address 1

95 Hayden Ave

Employer Contact Address 2

Employer Contact City

Lexington

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2421

Employer Contact Phone

617-794-2549

Employer Contact Email

ken.brown@takeda.com

Agent Attorney Name

Nana A OtutuaAmoah

Agent Attorney Firm Name

Zulkie Partners LLC

Agent Attorney Phone

(312) 831-2131

Agent Attorney Address 1

135 South La Salle Street

Agent Attorney Address 2

Ste. 3425

Agent Attorney City

Chicago

Agent Attorney State/Province

ILLINOIS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

60603

Agent Attorney Email

namoah@zulkiepartners.com

PW Track Number

P10022014832099

PW SOC Code

13-1041.07

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level IV

PW Wage

103875.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-09-26

PW Expiration Date

2023-06-30

Wage Offer From

130200.00

Wage Offer To

251100.00

Average Salary

190650.00

Wage Unit of Pay

Year

Worksite Address 1

95 Hayden Avenue

Worksite Address 2

Worksite City

Lexington

Worksite City Slug

lexington

Worksite State

MASSACHUSETTS

Worksite Postal Code

2421

Job Title

Sr. Principal Pharmacovigilance (PV) Scientist

Job Title Slug

sr-principal-pharmacovigilance-pv-scientist

Minimum Education

Master's

Major Field of Study

Regulatory Affairs or a related field or foreign equivalent degree

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

Y

Accept Alternative Combination Education

Bachelor's

Accept Alternative Combination Education Years

6

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

24

Accept Alternative Job Title

Sr. principal PV Scientist, Senior Safety Analysis Scientist, Pharmacovigilance Analyst, Pharmacovig

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Masters degree in Regulatory Affairs or a related field or foreign equivalent degree plus 2 years of related experience OR Bachelors degree in Regulatory Affairs or a related field or foreign equivalent degree plus 6 years of pharmacovigilance related experience. Conduct safety signal detection, assessment, management from various sources including medical scientific literature and global safety database 2 years; perform medical assessment of individual case and aggregate safety reports for product safety profile and address safety related regulatory authority requests 2 years; apply clinical trial methodology, various regulatory submissions, pharmacovigilance regulations, and safety profile to perform riskbenefit analysis risk management plan 2 years; utilize proficient communication skills with ability to review, analyze, interpret and present complex safety data to a high standard during internal and global crossfunctional collaborations for patient safety 2 years. Company headquarters in Lexington, MA. Individual may reside anywhere in the U.S. Telecommuting allowed from any location in the U.S.

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

2022-10-07

SWA Job Order End Date

2022-11-08

Sunday Edition Newspaper

Y

First Newspaper Name

Boston Sunday Globe

First Advertisement Start Date

2022-10-09

Second Newspaper Ad Name

Boston Sunday Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-10-16

Employer Website From Date

2022-10-07

Employer Website To Date

2023-01-23

Professional Organization Ad From Date

2024-01-01 01:04:06

Professional Organization Advertisement To Date

2024-01-01 01:04:06

Job Search Website From Date

2022-10-10

Job Search Website To Date

2022-11-08

Employee Referral Program From Date

2024-01-01 01:04:06

Employee Referral Program To Date

2024-01-01 01:04:06

Local Ethnic Paper From Date

2022-10-13

Local Ethnic Paper To Date

2022-10-13

Radio/TV Ad From Date

2024-01-01 01:04:06

Radio/TV Ad To Date

2024-01-01 01:04:06

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

2019

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

Nana A OtutuaAmoah

Preparer Title

Associate

Preparer Email

namoah@zulkiepartners.com

Employer Information Declaration Name

Ken Brown

Employer Information Declaration Title

Global Mobility Strategy Lead