• Manager - DSRM Training & Compliance

Industry : Pharma / Biotech / Clinical Research
Location : Mumbai
Open

Functional: Regulatory Affairs / Product Registration
Job Description
About Us :
Spectrum Talent Management is a comprehensive HR services company offering solutions spanning the entire talent life cycle including Recruitment, Onboarding, Payroll and Flexible Staffing. Founded in 2008, we are a continuously growing, yet mature service firm specializing in recruitment and staffing requirements of global organizations. Our leadership and high acceptance in the market is evident by the phenomenal growth that we have demonstrated in just few years of our inception. From Permanent recruitment to Flexi staffing, Payroll management to RPO, the orbit of the value add that we provide our customers with has always evolved, and diversified from time to time. This has enabled us to become a preferred vendor with most of our clients.
Roles and Responsibility :

1.         To manage global compliance on pharmacovigilance matters, DSRM

2.         To Prepare data, interpret and perform impact analysis regarding metrics for case processing and regulatory expedited reporting to regulatory authorities for DSRM and  Subsidiaries

3.         To develop and distribute regular reports regarding global compliance activities to leadership team and other key stakeholders

4.         To Perform impact analysis for PV compliance strategies, development of procedural documents and working practices, including inputs into SOPs, WIs, WPs, and other pertinent PV processes

5.         Implementation and Roll out of a companywide electronic learning management system

6.         Imparting Pharmacovigilance training to pharmacovigilance and non-pharmacovigilance employees, its subsidiaries and vendors globally

7.         To track compliance on training , subsidiaries and vendors on a routine basis

8.         Actively contribute to the development of processes, applications and methodologies in the department

9.         To actively contribute to continuous process development

 

 

Recruiter Name : Sugandha
Recruiter Email Id : sugandha@spectrumtalentmanagement.com
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