• Manager-DSRM

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.
About Company :
One of the leading pharmaceutical companies.
Roles and Responsibility :

Preparation and Maintenance of Pharmacovigilance System Master file (PSMF) for Europe, Eastern Europe and Detailed Description of Pharmacovigilance System (DDPS) for other regions

Preparation of project plan for integration of pharmacovigilance and drug safety between DSRM and subsidiaries

To act as a focal point of contact between central Drug Safety Risk Management team and teams based at various other locations globally (subsidiaries)

Ensure Pharmacovigilance due diligence in matters of company?s mergers and acquisitions

Management and maintenance of monthly PV compliance dashboard for EMEA and other regions

Coordination with vendors, internal and external stakeholders relevant for various DSRM functions

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

To actively contribute to continuous process development at DSRM.

 

Recruiter Name : Tripti
Recruiter Email Id : tripti.khute@stmpl.co.in
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