Agent/ Attorney Firm Name:Fragomen, Del Rey, Bernsen Loewy LLP
Agent/ Attorney Phone:2126888555
Agent/ Attorney Phone Ext.:
Agent/ Attorney Address Line 1:1400 Broadway
Agent/ Attorney Address Line 2:
Agent/ Attorney City:New York
Agent/ Attorney State/ Province:NEW YORK
Agent/ Attorney Country:UNITED STATES OF AMERICA
Agent/ Attorney Postal Code:10018
Agent/ Attorney Email:ACharniauskaya@fragomen.com
Position Info
Prevailing Wage Track Number:P10020346954451
Prevailing Wage SOC Code :13-1041
Prevailing Wage SOC Title :Regulatory Affairs Specialists
Prevailing Wage Skill Level:Level III
Prevailing Wage:89024
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:OES
Prevailing Wage Other Source:
Prevailing Wage Determination Date :2021-04-23
Prevailing Wage Expiration Date :2021-07-22
Wage Offer From:129189
Wage Offer To:
Wage Offer Unit of Pay:Year
Workstie Address Line 1:101 Orchard Ridge Drive
Worksite Address Line 2:
Worksite City :Gaithersburg
Worksite State:MARYLAND
Worksite Postal Code:20878
Job Title:Safety Scientist
Minimum Education:Master's
Other Degree/ Diploma:
Major Field of Study:Regulatory Affairs, Pharmacy or rel
Required Training:N
Required Training Month:
Required Field of Training:
Required Experience :Y
Required Expreience Months :36
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:36
Accept Alternate Job Title:Scientist, Validation Engineer or rel within patient safety or pharmaceutical industry
Normal Requirements of Job Opportunity:N
Required Foreign Language:N
Specific Skills:MUST HAVE A MASTERS DEGREE OR FOREIGN EQUIVALENT IN REGULATORY AFFAIRS, PHARMACY OR A RELATED FIELD PLUS THREE 3 YEARS OF EXPERIENCE IN THEbr POSITION OFFERED, AS A SCIENTIST, VALIDATION ENGINEER OR A RELATED POSITION WITHIN THE PATIENT SAFETY OR PHARMACEUTICAL INDUSTRY.br MUST HAVE THREE 3 YEARS OF EXPERIENCE IN THE PATIENT SAFETY OR PHARMACEUTICAL INDUSTRY IN EACH OF THE FOLLOWING WATERFALL AND AGILEbr METHODOLOGY FOR SOFTWARE DEVELOPMENT LIFE CYCLE; FDA 21 CFR PART 11ELECTRONIC RECORDS AND ESIGNATURES, 210, 211, ANNEX 11 REGULATIONS, GLOBAL QUALITY AND SAFETY REPORTING REGULATORY EXPECTATIONS INCLUDING AS GXP VALIDATION, ICH E2B R2R3HL7 STANDARDS, AND INDIVIDUAL CASE SAFETY REPORTING; DELIVERING VALIDATION STRATEGIES FOR GXP SYSTEMS INCLUDING EDMS, EQMS AND PHARMACOVIGILANCE SYSTEMS INCLUDING ARISG,br ARGUS SAFETY AND BESPOKE PV SYSTEM; DESIGN, DEPLOYMENT OF SOLUTIONS IN SUPPORT OF SAFETY IN THE CONTEXT OF PHARMACOVIGILANCE SYSTEMSbr INCLUDING ARISG, ARGUS SAFETY AND BESPOKE PV SYSTEM; PERFORM COMPUTER SYSTEM VALIDATION, TESTING AND TECHNICAL WRITING INCLUDING USERbr REQUIREMENTS, FUNCTIONAL REQUIREMENTS, RISK ASSESSMENTS, PART 11 AND ANNEX 11 REQUIREMENT ASSESSMENTS, PROCEDURAL CONTROLS, AND SOPbr PLANNING FORMS; AND TEST PROTOCOLS, INSTALLATION QUALIFICATION, OPERATIONAL QUALIFICATION, PERFORMANCE QUALIFICATION, CONFIGURATION REPORTS, TRACEABILITY MATRIX AND SUMMARY REPORTS FOR VARIOUS GXP SYSTEMS WITH STRICT ADHERENCE TO GAMP REGULATIONS.
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:2021-04-27
Job Oder End Date:2021-05-30
Sunday Edition Newspaper:Y
First Newspaper Name:The Washington Post
First Advertisement Start Date:2021-05-02
Second Newspaper Name:The Washington Post
Second Advertisement Type:Newspaper
Second Ad Start Date:2021-05-09
Job Fair From Date:
Job Fair to Date:
On Campus Recruiting from Date:
On Campus Recruiting to Date:
Employer Website from Date:2021-04-27
Employer Website to Date:2021-07-09
Pro. Org. Ad from Date:
Pro.Org. Ad to Date:
Job Search Website from Date:2021-05-02
Job Search Website to Date:2021-05-09
Private Employment Firm from Date:
Pricate Employment Firm to Date:
Employee Referral Program from Date:
Employee Referral Program to Date:
Campus Placement from Date:
Campus Placement to Date:
Local Ethnic Newspaper from Date:2021-05-05
Local Ethnic Newspaper to Date:2021-05-05
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:INDIA
Foreign Worker Birth Country:INDIA
Class of Admission :H-1B
Employee Info
Foreign Worker Education:Master's
Foreign Worker Education Other:
Foreign Worker Major:REGULATORY AFFAIRS FOR DRUGS, BIOLOGICS, AND MEDICAL DEVICES
Year of Compelted Education:2013
Foreign Worker Istitution of Eduation:NORTHEASTERN UNIVERSITY
Foreign Worker Education Instution Address Line 1:360 HUNTINGTON AVE
Foreign Worker Education Institution Address Line 2:
Foreign Worker Education Institution City:BOSTON
Foreign Worker Educatution Institution State:MA
Foreign Worker Education Institution Country :UNITED STATES OF AMERICA
Foreign Worker Education Training Post Code:2115
Foreign Worker Training Completion :N/A
Foreign Worker Required Experience :N
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:Hyla K Rosenberg
Preparer Title:Partner
Preparer Email :ACharniauskaya@fragomen.com
Employer Information Declaration Name:Adriana Echeverri
