Fiscal Year

2024

Case Number

A-23135-42700

Case Status

Certified

Received Date

2023-05-30

Decision Date

2024-07-08

Refile

N

Original File Date

2024-01-01 01:29:48

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Sage Therapeutics, Inc.

Employer Name Slug

sage-therapeutics-inc

Employer Address 1

215 First Street

Employer Address 2

Suite 3

Employer City

Cambridge

Employer City Slug

cambridge

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

2142

Employer Phone

6172998380

Employer Number of Employees

347

Employer Year Commenced Business

2010

NAICS Code

541711

FW Ownership Interest

N

Employer Contact Name

Zachary Kowzic

Employer Contact Address 1

215 First Street

Employer Contact Address 2

Suite 3

Employer Contact City

Cambridge

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2142

Employer Contact Phone

6172998380

Employer Contact Email

zach.kowzic@sagerx.com

Agent Attorney Name

Christina Elder

Agent Attorney Firm Name

Global Immigration Associates, P.C.

Agent Attorney Phone

3127226300

Agent Attorney Address 1

230 W. Monroe St.

Agent Attorney Address 2

Suite 2800

Agent Attorney City

Chicago

Agent Attorney State/Province

ILLINOIS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

60606

Agent Attorney Email

christina.elder@giafirm.com

PW Track Number

P10022250458292

PW SOC Code

11-9199

PW SOC Title

Managers, All Other

PW Skill Level

Level IV

PW Wage

180294.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2023-03-15

PW Expiration Date

2023-06-30

Wage Offer From

180294.00

Wage Offer To

0.00

Average Salary

180294.00

Wage Unit of Pay

Year

Worksite Address 1

215 First St.

Worksite Address 2

and unanticipated worksites

Worksite City

Cambridge

Worksite City Slug

cambridge

Worksite State

MASSACHUSETTS

Worksite Postal Code

2142

Job Title

Senior Manager, DSPV Quality, Compliance & Training

Job Title Slug

senior-manager-dspv-quality-compliance-training

Minimum Education

Bachelor's

Major Field of Study

Life Sciences, Pharmacy, Nursing or related field

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

60

Accept Alternative Job Title

experience in Pharmacovigilance

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

This position requires a Bachelors degree in Life Sciences, Pharmacy, Nursing, or related field plus 5 years of experience in Pharmacovigilance.br br This position requires 5 years of experience with the followingbr Pharmacovigilance processes such as safety data processing, MedDRA coding, expectedness determination, aggregate safety reports, safety database querying, pharmacovigilance system master file maintenance and E2bCIOMS reportingbr Processing, analyzing and querying safety data in safety databases based on ICH guidelines.br ICH guidelines.br br Comprehensive knowledge of the international pharmacovigilance regulations and requirements, including European Medicines Agency EMA Good Pharmacovigilance Practices GPVbr Assessing safety submission requirements in accordance with applicable FDA, EMA and worldwide regulatory requirements using E2b gateway and other available mediums.br Safety submission requirements including but not limited to mandatory data transmission standards and regulatory technical standards such as E2b R2R3 and CIOMS.br br Managing quality and compliance activitiesbr Performing root cause analysis and implementing corrective and preventive actions for deviations concerning safety submissions and regulatory and partner findings using quality tools and techniques.br br Working in Pharmacovigilance andor Pharmacovigilance processesbr Analyzing and evaluating the changing global regulatory environment and business partner agreements.br br Argus.

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

2023-03-22

SWA Job Order End Date

2023-04-26

Sunday Edition Newspaper

Y

First Newspaper Name

Boston Herald

First Advertisement Start Date

2023-04-09

Second Newspaper Ad Name

Boston Herald

Second Advertisement Type

Newspaper

Second Ad Start Date

2023-04-16

Employer Website From Date

2024-01-01 01:29:48

Employer Website To Date

2024-01-01 01:29:48

Professional Organization Ad From Date

2023-04-05

Professional Organization Advertisement To Date

2023-04-19

Job Search Website From Date

2023-04-05

Job Search Website To Date

2023-04-19

Employee Referral Program From Date

2024-01-01 01:29:48

Employee Referral Program To Date

2024-01-01 01:29:48

Local Ethnic Paper From Date

2023-04-13

Local Ethnic Paper To Date

2023-04-13

Radio/TV Ad From Date

2024-01-01 01:29:48

Radio/TV Ad To Date

2024-01-01 01:29:48

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

PHARMACEUTICAL SCIENCE

Foreign Worker Years of Education Completed

2008

Foreign Worker Institution of Education

KINGSTON UNIVERSITY

Foreign Worker Education Institution Address 1

5559 PENRHYN RD

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

KINGSTON UPON THAMES

Foreign Worker Education Institution State/Province

Foreign Worker Education Institution Country

UNITED KINGDOM

Foreign Worker Education Institution Postal Code

KT1 2EE

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Christina Elder

Preparer Title

Managing Attorney

Preparer Email

christina.elder@giafirm.com

Employer Information Declaration Name

Pamela Herbster

Employer Information Declaration Title

Executive Director