Fiscal Year

2022

Case Number

A-21112-77323

Case Status

Certified-Expired

Received Date

2021-05-04

Decision Date

2022-03-01

Refile

N

Original File Date

2022-01-01 11:00:19

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

INCYTE CORPORATION

Employer Name Slug

incyte-corporation

Employer Address 1

1801 AUGUSTINE CUTOFF

Employer Address 2

Employer City

WILMINGTON

Employer City Slug

wilmington

Employer State

DELAWARE

Employer State Slug

delaware

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

19803

Employer Phone

302-498-6700

Employer Number of Employees

1381

Employer Year Commenced Business

1991

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Anne Guntz

Employer Contact Address 1

1801 Augustine CutOff

Employer Contact Address 2

Employer Contact City

Wilmington

Employer Contact State/Province

DELAWARE

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

19803

Employer Contact Phone

302-498-6906

Employer Contact Email

aguntz@incyte.com

Agent Attorney Name

Licege D Dressler

Agent Attorney Firm Name

Graham Adair, Inc

Agent Attorney Phone

408-912-1050

Agent Attorney Address 1

675 North 1st Street

Agent Attorney Address 2

Suite 1050

Agent Attorney City

San Jose

Agent Attorney State/Province

CALIFORNIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

95112

Agent Attorney Email

ldressler@grahamdair.com

PW Track Number

P10020241794843

PW SOC Code

11-9199

PW SOC Title

Compliance Managers

PW Skill Level

N/A

PW Wage

97068.00

PW Unit of Pay

Year

PW Wage Source

Other

PW Determination Date

2021-01-04

PW Expiration Date

2021-06-30

Wage Offer From

120000.00

Wage Offer To

150000.00

Average Salary

135000.00

Wage Unit of Pay

Year

Worksite Address 1

2200 Concord Pike

Worksite Address 2

Worksite City

Wilmington

Worksite City Slug

wilmington

Worksite State

DELAWARE

Worksite Postal Code

19803

Job Title

Sr. Pharmacovigilance Operations Compliance Manager

Job Title Slug

sr-pharmacovigilance-operations-compliance-manager

Minimum Education

Master's

Major Field of Study

Regulatory Affairs for Drugs, Biologics, & Medical Devices

Required Training

N

Required Experience

Y

Required Experience Months

60

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Pharmacy, Healthcare or related field

Accept Alternative Combination

Y

Accept Alternative Combination Education

Bachelor's

Accept Alternative Combination Education Years

7

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

60

Accept Alternative Job Title

Pharmacovigilance Operations Compliance Manager or related occupation

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Position requires Masters degree or foreign equivalent in Regulatory Affairs for Drugs, Biologics, Medical Devices, Pharmacy, Healthcare or related field and 5 years of experience in job offered or related occupation. Will accept Bachelors degree and 7 years of experience in lieu of MS5. Skills Required 1. Experience with Pharmacovigilance or other equivalent clinical or pharmaceutical experience; 2. Experience with quality and compliance in the pharmaceutical industry; 3. Experience with quality investigation process CAPA and RCA processes; 4. Experience with audit and inspection processes; 5. Experience using safety database systems Argus; and 6. Knowledge of global Pharmacovigilance regulations CFRGVP, ICH Guidelines, and Good Clinical Practices, with emphasis on reporting rules and timelines.

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

2021-01-19

SWA Job Order End Date

2021-02-22

Sunday Edition Newspaper

Y

First Newspaper Name

Delaware News Journal

First Advertisement Start Date

2021-02-07

Second Newspaper Ad Name

Delaware News Journal

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-02-14

Employer Website From Date

2022-01-01 11:00:19

Employer Website To Date

2022-01-01 11:00:19

Professional Organization Ad From Date

2022-01-01 11:00:19

Professional Organization Advertisement To Date

2022-01-01 11:00:19

Job Search Website From Date

2021-02-08

Job Search Website To Date

2021-02-16

Employee Referral Program From Date

2022-01-01 11:00:19

Employee Referral Program To Date

2022-01-01 11:00:19

Local Ethnic Paper From Date

2021-02-11

Local Ethnic Paper To Date

2021-02-11

Radio/TV Ad From Date

2022-01-01 11:00:19

Radio/TV Ad To Date

2022-01-01 11:00:19

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

2012

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

Licege D Dressler

Preparer Title

Attorney at Law

Preparer Email

licege.dressler@bakerlawcorp.com

Employer Information Declaration Name

Anne Guntz

Employer Information Declaration Title

Director, Human Resources