Agent/ Attorney Firm Name:Mintz Levin Cohn Ferris Glovsky and Popeo PC
Agent/ Attorney Phone:(617) 239-8498
Agent/ Attorney Phone Ext.:
Agent/ Attorney Address Line 1:One Financial Center
Agent/ Attorney Address Line 2:Flr. 41
Agent/ Attorney City:Boston
Agent/ Attorney State/ Province:MASSACHUSETTS
Agent/ Attorney Country:UNITED STATES OF AMERICA
Agent/ Attorney Postal Code:2111
Agent/ Attorney Email:mkline@mintz.com
Position Info
Prevailing Wage Track Number:P10020338937040
Prevailing Wage SOC Code :11-9199
Prevailing Wage SOC Title :Compliance Managers
Prevailing Wage Skill Level:Level II
Prevailing Wage:106413
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:OES
Prevailing Wage Other Source:
Prevailing Wage Determination Date :2021-05-19
Prevailing Wage Expiration Date :2021-08-17
Wage Offer From:150000
Wage Offer To:
Wage Offer Unit of Pay:Year
Workstie Address Line 1:45 Sidney Street
Worksite Address Line 2:
Worksite City :Cambridge
Worksite State:MASSACHUSETTS
Worksite Postal Code:2139
Job Title:Sr. Manager Drug Safety & Pharmacovigilance Operations
Minimum Education:Master's
Other Degree/ Diploma:
Major Field of Study:Pharmaceutics, Pharmacy, Regulatory Affairs or related field
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:24
Accept Alternate Job Title:Any providing experience as specified in H.14.
Normal Requirements of Job Opportunity:N
Required Foreign Language:N
Specific Skills:ALL Requirements Masters degree, or foreign equivalent, in Pharmaceutics, Pharmacy, Regulatory Affairs or related field and 2 years of related experience within the pharmaceutical industry performing quality and regulatory control, including compliance and enforcement inspection, training requirements, monitoring performance, implementing continuous improvement actions and documentation practices within clinical development programs. Experience, which may be gained concurrently, must includebr 2 years of experience working with CROs vendors, and relationship management within drug safetyPharmacovigilance in a pharmaceutical industry setting;br 2 years of experience in global pharmacovigilance operations overseeing safety data collection for products under investigation Clinical Trials and products approved globally;br 2 years of experience using multiple databases Arisg, Argus, including MedDra coding and command over Data entry guidelines to effectively oversee all aspects of ICSR case processing; andbr 2 years of experience using knowledge on FDA, EU legislation and ICH Efficacy guidelines within drug safety department.
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:2021-10-14
Job Oder End Date:2021-11-18
Sunday Edition Newspaper:Y
First Newspaper Name:Boston Sunday Globe
First Advertisement Start Date:2021-11-07
Second Newspaper Name:Boston Sunday Globe
Second Advertisement Type:Newspaper
Second Ad Start Date:2021-11-14
Job Fair From Date:
Job Fair to Date:
On Campus Recruiting from Date:
On Campus Recruiting to Date:
Employer Website from Date:2021-08-10
Employer Website to Date:2021-10-26
Pro. Org. Ad from Date:
Pro.Org. Ad to Date:
Job Search Website from Date:2021-11-09
Job Search Website to Date:2021-11-22
Private Employment Firm from Date:
Pricate Employment Firm to Date:
Employee Referral Program from Date:2021-08-10
Employee Referral Program to Date:2021-10-26
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: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:MS IN REGULATORY AFFAIRS AND HEALTH POLICY
Year of Compelted Education:2015
Foreign Worker Istitution of Eduation:MCPHS UNIVERSITY
Foreign Worker Education Instution Address Line 1:179 LONGWOOD 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/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:Maryanne Kline
Preparer Title:Attorney
Preparer Email :mkline@mintz.com
Employer Information Declaration Name:Debbie Bumpus
