Fiscal Year

2021

Case Number

A-21062-57811

Case Status

Certified

Received Date

2021-03-23

Decision Date

2021-08-17

Refile

N

Original File Date

2021-01-01 10:01:21

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

IQVIA INC

Employer Name Slug

iqvia-inc

Employer Address 1

4820 EMPIROR BLVD

Employer Address 2

Employer City

DURHAM

Employer City Slug

durham

Employer State

NORTH CAROLINA

Employer State Slug

north-carolina

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

27703

Employer Phone

6787565637

Employer Number of Employees

50000

Employer Year Commenced Business

1982

NAICS Code

325411

FW Ownership Interest

N

Employer Contact Name

Kiara Mallardi

Employer Contact Address 1

One IMS Drive

Employer Contact Address 2

Employer Contact City

Plymouth Meeting

Employer Contact State/Province

PENNSYLVANIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

19462

Employer Contact Phone

484-535-0554

Employer Contact Email

kiara.mallardi@iqvia.com

Agent Attorney Name

Hannah F Little

Agent Attorney Firm Name

Garfinkel Immigration Law Firm

Agent Attorney Phone

704-442-8000

Agent Attorney Address 1

6100 Fairview Road

Agent Attorney Address 2

Ste 200

Agent Attorney City

Charlotte

Agent Attorney State/Province

NORTH CAROLINA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

28210

Agent Attorney Email

attorneys@garfinkelimmigration.com

PW Track Number

P10020273849381

PW SOC Code

15-2041

PW SOC Title

Clinical Data Managers

PW Skill Level

Level IV

PW Wage

148949.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-03-02

PW Expiration Date

2021-06-30

Wage Offer From

148949.00

Wage Offer To

0.00

Average Salary

148949.00

Wage Unit of Pay

Year

Worksite Address 1

135 Main Street

Worksite Address 2

Must telecommute from anywhere in the U.S.

Worksite City

San Francisco

Worksite City Slug

san-francisco

Worksite State

CALIFORNIA

Worksite Postal Code

94105

Job Title

Drug Safety Program Manager

Job Title Slug

drug-safety-program-manager

Minimum Education

Bachelor's

Major Field of Study

Life Sciences

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Pharmacology, Toxicology or related

Accept Alternative Combination

Y

Accept Alternative Combination Education

Master's

Accept Alternative Combination Education Years

3

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

60

Accept Alternative Job Title

Same or related like Drug Safety Specialist

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Requires a Bachelors or Masters degree in Life Sciences, Pharmacology, Toxicology or related or equivalent. Requires if Bachelors five 5 years or if Masters three 3 years pharmaceutical, biotechnology or CRO industry REMS Operations, Medical Affairs, Regulatory or Pharmacovigilance or relevant disciplines experience to include if Bachelors 5 years or if Masters 3 years delivering pharmacovigilance PV and regulatory affairs services for clinical and post marketed product engagements; consulting and advising with pharmaceutical co. drug safety teams and clinical and post marketing PV teams; managing program financials; managing offshore resources and teams; utilizing knowledge of development and postmarketing safety requirements per ICH, US and international regulations and guidelines and Good Pharmacovigilance Practice; utilizing knowledge of medical and drug terminology including clinical trial and postmarketing safety regulations; utilizing knowledge of case processing, expedited reporting rules and safety database concepts; utilizing knowledge of global regulations governing PV in the pharmaceutical industry and research and development processes; utilizing knowledge of safety databases like Argus and MedDRA and WHO dictionary with relevance to SAE analysis and SAE coding; MS Word, Excel and PowerPoint. Work M F, 8 a 5 p PST and required to be on conference calls with East Coast team members and project resources on a daily basis and support India hours of operations with pharmacovigilance delivery center in Bangalore and Sri Lanka. Requires 4060 domestic travel to attend client and quarterly meetings and annual meetings.

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

2021-01-15

SWA Job Order End Date

2021-02-14

Sunday Edition Newspaper

Y

First Newspaper Name

San Francisco Chronicle

First Advertisement Start Date

2020-11-15

Second Newspaper Ad Name

San Francisco Chronicle

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-11-22

Employer Website From Date

2021-01-01 10:01:21

Employer Website To Date

2021-01-01 10:01:21

Professional Organization Ad From Date

2021-01-01 10:01:21

Professional Organization Advertisement To Date

2021-01-01 10:01:21

Job Search Website From Date

2020-11-18

Job Search Website To Date

2020-11-24

Employee Referral Program From Date

2021-01-01 10:01:21

Employee Referral Program To Date

2021-01-01 10:01:21

Local Ethnic Paper From Date

2020-11-18

Local Ethnic Paper To Date

2020-11-18

Radio/TV Ad From Date

2021-01-01 10:01:21

Radio/TV Ad To Date

2021-01-01 10:01:21

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 AND TOXICOLOGY

Foreign Worker Years of Education Completed

2013

Foreign Worker Institution of Education

LONG ISLAND UNIVERSITY BROOKLYN CAMPUS

Foreign Worker Education Institution Address 1

1 UNIVERSITY PLAZA

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BROOKLYN

Foreign Worker Education Institution State/Province

NY

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

11201

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Hannah F Little

Preparer Title

Partner

Preparer Email

attorneys@garfinkelimmigration.com

Employer Information Declaration Name

Kiara Mallardi

Employer Information Declaration Title

Immigration Specialist