Fiscal Year

2023

Case Number

A-22049-13539

Case Status

Certified

Received Date

2022-05-02

Decision Date

2023-01-18

Refile

N

Original File Date

2023-01-01 08:13:55

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

EMD SERONO RESEARCH DEVELOPMENT INSTITUTE, INC.

Employer Name Slug

emd-serono-research-development-institute-inc

Employer Address 1

400 SUMMIT DRIVE

Employer Address 2

Employer City

BURLINGTON

Employer City Slug

burlington

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

1803

Employer Phone

6033209491

Employer Number of Employees

654

Employer Year Commenced Business

1989

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Rhonda Francione

Employer Contact Address 1

400 SUMMIT DRIVE

Employer Contact Address 2

Employer Contact City

BURLINGTON

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

1803

Employer Contact Phone

6033209491

Employer Contact Email

rhonda.francione@milliporesigma.com

Agent Attorney Name

Magaly R Cheng

Agent Attorney Firm Name

Clark Lau LLC

Agent Attorney Phone

6172994200

Agent Attorney Address 1

155 Federal Street

Agent Attorney Address 2

Suite 400

Agent Attorney City

Boston

Agent Attorney State/Province

MASSACHUSETTS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

2110

Agent Attorney Email

mcheng@clarklau.com

PW Track Number

P10021151356877

PW SOC Code

13-1041

PW SOC Title

Compliance Officers

PW Skill Level

Level II

PW Wage

73424.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-11-08

PW Expiration Date

2022-06-30

Wage Offer From

120000.00

Wage Offer To

150000.00

Average Salary

135000.00

Wage Unit of Pay

Year

Worksite Address 1

One Technology Place

Worksite Address 2

Worksite City

Rockland

Worksite City Slug

rockland

Worksite State

MASSACHUSETTS

Worksite Postal Code

2370

Job Title

Patient Safety Specialist

Job Title Slug

patient-safety-specialist

Minimum Education

Bachelor's

Major Field of Study

Pharmacy or pharmacology

Required Training

N

Required Experience

N

Required Experience Months

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

See H.14

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Employer requires a Bachelors degree in Pharmacy or pharmacology and three 3 years of work experience in drug and patient safety in the pharmaceutical industry or health authority local regulatory pharmacovigilance legislation with knowledge to assess and process all types of patient reports utilizing the safety databasestools ARISg, IRT and OST.br br In addition, the following specific skills are requiredbr br Demonstrated ability establishing and ensuring implementation of safety standards for US commercial and medical organization programs in alignment with US and global adverse event requirements, by determining safety and efficacy for products which are in clinical trials and in postmarketing safety surveillance, gained through three 3 years of work experience.br Demonstrated ability ensuring systems and standards are aligned with the company, Global Patient Safety and global quality and compliance requirements; and are consistent with applicable US and global regulations gained through three 3 years of work experience.br Demonstrated ability conducting assessment and gap analysis relating to the impact of new proposed FDA regulations gained through one 1 year of work experience.br Demonstrated ability collaborating in crossfunctional teams to implement new FDA regulations gained through three 3 years of work experience.br Demonstrated experience working closely with US and Global Regulatory to ensure timely reporting to the US Health Authority for US Safety Reports gained through two 2 year years of work experience.br br All years of experience may be gained concurrently.

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

2021-12-16

SWA Job Order End Date

2022-01-25

Sunday Edition Newspaper

Y

First Newspaper Name

Boston Globe

First Advertisement Start Date

2022-01-09

Second Newspaper Ad Name

Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-01-16

Employer Website From Date

2021-12-16

Employer Website To Date

2022-01-25

Professional Organization Ad From Date

2023-01-01 08:13:55

Professional Organization Advertisement To Date

2023-01-01 08:13:55

Job Search Website From Date

2021-12-17

Job Search Website To Date

2022-01-25

Employee Referral Program From Date

2021-12-16

Employee Referral Program To Date

2022-01-25

Local Ethnic Paper From Date

2023-01-01 08:13:55

Local Ethnic Paper To Date

2023-01-01 08:13:55

Radio/TV Ad From Date

2023-01-01 08:13:55

Radio/TV Ad To Date

2023-01-01 08:13:55

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

PHARMACOLOGY

Foreign Worker Years of Education Completed

2012

Foreign Worker Institution of Education

ANDHRA UNIVERSITY

Foreign Worker Education Institution Address 1

WALTAIR JUNCTION

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

VISAKHAPATNAM

Foreign Worker Education Institution State/Province

ANDHRA PRADESH

Foreign Worker Education Institution Country

INDIA

Foreign Worker Education Institution Postal Code

530003

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Magaly R Cheng

Preparer Title

Attorney

Preparer Email

mcheng@clarklau.com

Employer Information Declaration Name

Rhonda Francione

Employer Information Declaration Title

Sr. Specialist, Mobility and Immigration NA