Previous State Work Force Agency (SWA) Case Number Stete:
Schedule A or a Sheepherder Occupation :N
Company Info
Employer Name:Taro Pharmaceuticals USA, Inc
Employer Address_Line 1:3 Skyline Drive
Employer Address_Line 2:
Employer City :Hawthorne
State:
Employer State/ Province:NEW YORK
Employer Country:UNITED STATES OF AMERICA
Employer Postal Code:10532
Employer Phone No.:914-345-9001
Employer Phone Extent No.:6733
Total Number of Employees:246
Employer Year of Commenced :
NAICS Code:325412
Foreign Worker Ownership & Interest:N
HR Info
Employer Contact Name:Susanne Foulds
Employer Contact Address Line1:3 Skyline Drive
Employer Contact Address Line2:
Employer Contact City:Hawthorne
Employer Contact State/ Provice:NEW YORK
Employer Contact Country :UNITED STATES OF AMERICA
Employer Contact Post Code:10532
Employer Contact Phone:914-345-9001 6733
Employer Contact Email:Susanne.Foulds@taro.com
Attorney
Agent/ Attorney Name:Rona M Lum
Agent/ Attorney Firm Name:Law Offices of Rona M. Lum
Agent/ Attorney Phone:2483401854
Agent/ Attorney Phone Ext.:
Agent/ Attorney Address Line 1:691 N. Squirrel Road
Agent/ Attorney Address Line 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
Position Info
Prevailing Wage Track Number:P10020311903104
Prevailing Wage SOC Code :11-9199
Prevailing Wage SOC Title :Regulatory Affairs Managers
Prevailing Wage Skill Level:Level IV
Prevailing Wage:178464
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:OES
Prevailing Wage Other Source:
Prevailing Wage Determination Date :2021-03-29
Prevailing Wage Expiration Date :2021-06-30
Wage Offer From:178464
Wage Offer To:
Wage Offer Unit of Pay:Year
Workstie Address Line 1:3 Skyline Drive
Worksite Address Line 2:
Worksite City :Hawthorne
Worksite State:NEW YORK
Worksite Postal Code:10532
Job Title:Senior Manager, Drug Safety
Minimum Education:Other
Other Degree/ Diploma:Doctor of Pharmacy (PharmD) or Medical degree (M.D.)
Major Field of Study:Doctor of Pharmacy (PharmD) or Medical degree (M.D.)
Required Training:N
Required Training Month:
Required Field of Training:
Required Experience :N
Required Expreience Months :
Accept Alternate Field of Study:N
Accept Alternate Major:
Alternate Combination of Education/ Experience:N
Required Alternate Level of Education :
Other Alternate Level of Education:
Acceptable Years of Experience:
Accept Foreign Educationa:Y
Acceptable Alternate Occupation:Y
Acceptable Alternate Occupation Month:48
Accept Alternate Job Title:any suitable position in Pharmacovigilance and Drug Safety as stated in section H.14
Normal Requirements of Job Opportunity:Y
Required Foreign Language: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 Applied Foreign Worker:Y
ForeignWorker Live on Premises :N
Live in Domestic Service Worker:N
Employment Contract :
Professional Occupation :Y
College/ University Teacher:N
Competitive Process:
Basic Recruitment Process :
Teacher Select Date:
Teacher Publish Journal Name:
Additional Recruitment Information:
Job Oder Start Date:2021-04-21
Job Oder End Date:2021-05-21
Sunday Edition Newspaper:Y
First Newspaper Name:Journal News
First Advertisement Start Date:2021-05-09
Second Newspaper Name:Journal News
Second Advertisement Type:Newspaper
Second Ad Start Date:2021-05-16
Job Fair From Date:
Job Fair to Date:
On Campus Recruiting from Date:
On Campus Recruiting to Date:
Employer Website from Date:2021-04-21
Employer Website to Date:2021-05-06
Pro. Org. Ad from Date:
Pro.Org. Ad to Date:
Job Search Website from Date:2021-04-25
Job Search Website to Date:2021-05-18
Private Employment Firm from Date:
Pricate Employment Firm to Date:
Employee Referral Program from Date:2021-04-21
Employee Referral Program to Date:2021-05-21
Campus Placement from Date:
Campus Placement to Date:
Local Ethnic Newspaper from Date:
Local Ethnic Newspaper to Date:
Radio/TV Ad from Date:
Radio/TV Ad to Date:
Employer Received the Payment:N
Payment Details:
Bargaining Representative Notified:N/A
Posted Notice at Worksite:Y
Layoff in Past Six Months:N
US Worker Considered:
Country of Citizenship:CANADA
Foreign Worker Birth Country:CHINA
Class of Admission :H-1B
Employee Info
Foreign Worker Education:Other
Foreign Worker Education Other:DOCTOR OF MEDICINE
Foreign Worker Major:DOCTOR OF MEDICINE
Year of Compelted Education:1993
Foreign Worker Istitution of Eduation:TONGJI MEDICAL UNIVERSITY
Foreign Worker Education Instution Address Line 1:NO. 1239, SIPING ROAD
Foreign Worker Education Institution Address Line 2:
Foreign Worker Education Institution City:SHANGHAI CITY
Foreign Worker Educatution Institution State:
Foreign Worker Education Institution Country :CHINA
Foreign Worker Education Training Post Code:200092
Foreign Worker Training Completion :N/A
Foreign Worker Required Experience :N/A
Foreign Worker Alternate Education and Experience :N/A
Foreign Worker Alternate Occupation Experience:Y
Foreign Worker Experience with Employer:N
Foreign Worker Employer Pay 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 Declaration Title:Director, Human Resources
