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Case Number: A-20356-35283

Fiscal year: 2021

Fiscal Year

2021

Case Number

A-20356-35283

Case Status

Certified

Received Date

2021-01-14

Decision Date

2021-06-30

Refile

N

Original File Date

2021-01-01 09:44:28

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

INTERSECT ENT

Employer Name Slug

intersect-ent

Employer Address 1

1555 ADAMS DRIVE

Employer Address 2

Employer City

MENLO PARK

Employer City Slug

menlo-park

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

94025

Employer Phone

650-788-7947

Employer Number of Employees

189

Employer Year Commenced Business

2006

NAICS Code

339113

FW Ownership Interest

N

Employer Contact Name

Cate McCarrell

Employer Contact Address 1

1555 Adams Drive

Employer Contact Address 2

Employer Contact City

Menlo Park

Employer Contact State/Province

CALIFORNIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

94025

Employer Contact Phone

6502826219

Employer Contact Email

cmccarrell@intersectent.com

Agent Attorney Name

JAMES Y PACK

Agent Attorney Firm Name

Fragomen, Del Rey, Bernsen Loewy, LLP

Agent Attorney Phone

9492610209

Agent Attorney Address 1

18401 Von Karman Avenue

Agent Attorney Address 2

Suite 255

Agent Attorney City

Irvine

Agent Attorney State/Province

CALIFORNIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

92612

Agent Attorney Email

dallert@fragomen.com

PW Track Number

P10020178682613

PW SOC Code

11-9199

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level III

PW Wage

168917.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-11-23

PW Expiration Date

2021-06-30

Wage Offer From

180003.02

Wage Offer To

0.00

Average Salary

180003.02

Wage Unit of Pay

Year

Worksite Address 1

1555 Adams Drive

Worksite Address 2

Worksite City

Menlo Park

Worksite City Slug

menlo-park

Worksite State

CALIFORNIA

Worksite Postal Code

94025

Job Title

Senior Manager, Drug Safety and Pharmacovigilance

Job Title Slug

senior-manager-drug-safety-and-pharmacovigilance

Minimum Education

Master's

Major Field of Study

LIFE SCIENCES*

Required Training

N

Required Experience

Y

Required Experience Months

36

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

See H.14 for complete list

Accept Alternative Combination

Y

Accept Alternative Combination Education

Bachelor's

Accept Alternative Combination Education Years

6

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

36

Accept Alternative Job Title

In job offered or closely related occupation

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

A MASTERS DEGREE OR FOREIGN EQUIVALENT IN LIFE SCIENCES, BIOTECHNOLOGY, NURSING, PHARMACY, OR IN A CLOSELY RELATED FIELD, PLUS 3 YEARS OF WORK EXPERIENCE IN JOB OFFERED OR CLOSELY RELATED OCCUPATION. IN THE ALTERNATE, A BACHELORS DEGREE OR FOREIGN EQUIVALENT IN LIFE SCIENCES, BIOTECHNOLOGY, NURSING, PHARMACY, OR IN A CLOSELY RELATED FIELD, PLUS 6 YEARS OF WORK EXPERIENCE IN JOB OFFERED OR CLOSELY RELATED OCCUPATION.br br MUST POSSESS EXPERTISEKNOWLEDGE SUFFICIENT TO ADEQUATELY PERFORM THE DUTIES OF THE JOB BEING OFFERED. EXPERTISEKNOWLEDGE MAY BE GAINED THROUGH EMPLOYMENT EXPERIENCE OR EDUCATION. SUCH EXPERTISE KNOWLEDGE CANNOT BE quot;QUANTIFIEDquot; BY quot;TIME.quot;br br 1. EXPERIENCE COMPLETING INDIVIDUAL CASE SAFETY REPORTS ICSRS AND FDA FORM MEDWATCH 3500 A FOR SUBMISSION ON THE FDA SAFETY REPORTING PORTAL.br 2. WORKING KNOWLEDGE OF MEDDRA AND WHO DRUG CODING DICTIONARIES.br 3. UTILIZE DRUG SAFETY DATABASES ARISG AND ARGUS.br 4. APPLICATION OF FDA AND ICH SAFETY GUIDELINES FOR DRUG AND DEVICE COMBINATION PRODUCTS.br br EMPLOYER WILL ACCEPT ANY SUITABLE COMBINATION OF EDUCATION, TRAINING OR EXPERIENCE.

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

2020-10-02

SWA Job Order End Date

2020-11-04

Sunday Edition Newspaper

Y

First Newspaper Name

San Francisco Chronicle

First Advertisement Start Date

2020-10-18

Second Newspaper Ad Name

San Francisco Chronicle

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-10-25

Employer Website From Date

2021-01-01 09:44:28

Employer Website To Date

2021-01-01 09:44:28

Professional Organization Ad From Date

2021-01-01 09:44:28

Professional Organization Advertisement To Date

2021-01-01 09:44:28

Job Search Website From Date

2020-10-20

Job Search Website To Date

2020-10-26

Employee Referral Program From Date

2020-10-02

Employee Referral Program To Date

2020-10-19

Local Ethnic Paper From Date

2021-01-01 09:44:28

Local Ethnic Paper To Date

2021-01-01 09:44:28

Radio/TV Ad From Date

2020-10-24

Radio/TV Ad To Date

2020-10-24

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

BIOTECHNOLOGY AND CHEMICAL SCIENCE

Foreign Worker Years of Education Completed

2012

Foreign Worker Institution of Education

ROOSEVELT UNIVERSITY

Foreign Worker Education Institution Address 1

430 SOUTH MICHIGAN AVENUE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

CHICAGO

Foreign Worker Education Institution State/Province

IL

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

60605

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

JAMES Y PACK

Preparer Title

PARTNER

Preparer Email

jpack@fragomen.com

Employer Information Declaration Name

Cate MCCARRELL

Employer Information Declaration Title

Senior Director, Human Resources