Fiscal Year

2022

Case Number

A-21144-90908

Case Status

Certified-Expired

Received Date

2021-06-23

Decision Date

2021-11-18

Refile

N

Original File Date

2022-01-01 10:27:01

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Taro Pharmaceuticals USA, Inc

Employer Name Slug

taro-pharmaceuticals-usa-inc

Employer Address 1

3 Skyline Drive

Employer Address 2

Employer City

Hawthorne

Employer City Slug

hawthorne

Employer State

NEW YORK

Employer State Slug

new-york

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

10532

Employer Phone

914-345-9001

Employer Number of Employees

246

Employer Year Commenced Business

1965

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Susanne Foulds

Employer Contact Address 1

3 Skyline Drive

Employer Contact Address 2

Employer Contact City

Hawthorne

Employer Contact State/Province

NEW YORK

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

10532

Employer Contact Phone

914-345-9001 6733

Employer Contact Email

Susanne.Foulds@taro.com

Agent Attorney Name

Rona M Lum

Agent Attorney Firm Name

Law Offices of Rona M. Lum

Agent Attorney Phone

2483401854

Agent Attorney Address 1

691 N. Squirrel Road

Agent Attorney Address 2

Suite 185

Agent Attorney City

Auburn Hills

Agent Attorney State/Province

MICHIGAN

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

48326

Agent Attorney Email

rlum@corpimmigration.us

PW Track Number

P10020311903104

PW SOC Code

11-9199

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level IV

PW Wage

178464.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-03-29

PW Expiration Date

2021-06-30

Wage Offer From

178464.00

Wage Offer To

0.00

Average Salary

178464.00

Wage Unit of Pay

Year

Worksite Address 1

3 Skyline Drive

Worksite Address 2

Worksite City

Hawthorne

Worksite City Slug

hawthorne

Worksite State

NEW YORK

Worksite Postal Code

10532

Job Title

Senior Manager, Drug Safety

Job Title Slug

senior-manager-drug-safety

Minimum Education

Other

Major Field of Study

Doctor of Pharmacy (PharmD) or Medical degree (M.D.)

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

48

Accept Alternative Job Title

any suitable position in Pharmacovigilance and Drug Safety as stated in section H.14

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Doctor of Pharmacy PharmD or Medical degree M.D., foreign educ. equiv. acceptable, and minimum 4 years of managerial experience in the pharmaceutical industry with complete familiarity with FDA and ICH regulations and guidelines related to Drug Safety and Pharmacovigilance practices. Extensive familiarity with MedDRA and MedDRA coding, Argus safety database and LAM Local Affiliate Module application and preparation of Periodic Adverse Drug Event Reports PADERS and process of safety signal detection is required. Travel required for participation in FDA conferences, PV audits and global meetings with Taro affiliates.br Explanation of Business Necessity for Educational and Experience Requirementsbr br Taro Pharmaceuticals USA, Inc. is headquartered in Hawthorne, New York. Taro USA is part of a multinational, sciencebased pharmaceutical company. We develop, manufacture and market Rx and OTC pharmaceutical products in the U.S. Our primary areas of focus include semisolid formulations such as creams and ointments and other dosage forms such as liquids, capsules and tablets, mainly in the dermatological and topical, cardiovascular, neuropsychiatric and antiinflammatory therapeutic categories. Taro USA markets and distributes both proprietary and generic products in the U.S. market.br The position of Senior Manager, Drug Safety is a highly technical position within our company that requires specific knowledge and experience in Pharmacovigilance and Drug Safety matters within the pharmaceutical industry. The information that the person must review, analyze, and disseminate to staff and other stakeholders is highly scientific in nature, and involves knowledge of the medical field, and the manner in which pharmaceutical products react in the human body.br The individual in this position is responsible for executing pharmacovigilance and drug safety activities to ensure regulatory compliance with FDA regulations, procedures, and contractual requirements for Taro sites worldwide. Pharmacovigilance is the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other drugrelated problem. The Senior Manager, Drug Safety provides support and oversight in related Drug Safety activities including Product Quality Complaints and Medical Information activities. Heshe acts as a Subject Matter Expert SME for pharmacovigilance audits of affiliates and vendors, and represents U.S. Taro Drug Safety during FDA inspections. The Senior Manager, Drug Safety is also responsible for managing the U.S. Drug Safety staff, including work distribution and performance evaluations and pharmacovigilance budgeting. The pharmaceutical industry is highly regulated. Taro USA must meet requirements for the preparation and filing of technical documents for New Drug Applications NDAs, Abbreviated New Drug Applications ANDAs, Drug Master Files DMFs, and Investigational New Drug programs INDs.br Due to the highly complex, scientific, and technical nature of this position, it is imperative that the individual possess either a Doctor of Pharmacy PharmD or Medical Degree M.D., foreign educational equivalent is acceptable, and a minimum of four 4 years of managerial experience in the pharmaceutical industry with complete familiarity with FDA and ICH regulations and guidelines related to Drug Safety and Pharmacovigilance practices. Extensive familiarity with MedDRA and MedDRA coding, Argus safety database and LAM Local Affiliate Module application and preparation of Periodic Adverse Drug Event Reports PADERS and process of safety signal detection is required.br Any individual who holds the position of Senior Manager, Drug Safety for our company or for any pharmaceutical company, cannot adequately carry out the demanding responsibilities of this position without the required stated experience and formal education.

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

2021-04-21

SWA Job Order End Date

2021-05-21

Sunday Edition Newspaper

Y

First Newspaper Name

Journal News

First Advertisement Start Date

2021-05-09

Second Newspaper Ad Name

Journal News

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-05-16

Employer Website From Date

2021-04-21

Employer Website To Date

2021-05-06

Professional Organization Ad From Date

2022-01-01 10:27:01

Professional Organization Advertisement To Date

2022-01-01 10:27:01

Job Search Website From Date

2021-04-25

Job Search Website To Date

2021-05-18

Employee Referral Program From Date

2021-04-21

Employee Referral Program To Date

2021-05-21

Local Ethnic Paper From Date

2022-01-01 10:27:01

Local Ethnic Paper To Date

2022-01-01 10:27:01

Radio/TV Ad From Date

2022-01-01 10:27:01

Radio/TV Ad To Date

2022-01-01 10:27:01

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

CANADA

Foreign Worker Birth Country

CHINA

Class of Admission

H-1B

Foreign Worker Education

Other

Foreign Worker Information: Major

DOCTOR OF MEDICINE

Foreign Worker Years of Education Completed

1993

Foreign Worker Institution of Education

TONGJI MEDICAL UNIVERSITY

Foreign Worker Education Institution Address 1

NO. 1239, SIPING ROAD

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

SHANGHAI CITY

Foreign Worker Education Institution State/Province

Foreign Worker Education Institution Country

CHINA

Foreign Worker Education Institution Postal Code

200092

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Rona M Lum

Preparer Title

Attorney

Preparer Email

rlum@corpimmigration.us

Employer Information Declaration Name

Susanne Foulds

Employer Information Declaration Title

Director, Human Resources