Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.
Post : Patient Safety Manager
Job Description
• Acts as the point of contact person with the Health Authority on safety related matters.
• Implementation and maintenance of Risk management plans
• Implementation and maintenance of Additional Risk Minimization Materials.
• Handel safety information related activities
• Identification of PV activities and implementation of SOPs
• Implementation of PV Audit and Inspection Readiness
• Development of training modules and organizing trainings
• Planning, processing and reporting of Aggregate Reports to HA
• Establishment and maintenance of Quality Management System (QMS)
• Implementation of Pharmacovigilance Agreements
• Collection, follow-up and forwarding of spontaneous, literature, solicited, post- marketing AE cases (as applicable)
• Submission of single cases from Clinical Trials to local Health Agencies (HA) and Ethics Committees as per requirement.
• Handel Local Market Safety Data Quality
• Implementation and maintenance of Local PSMF
Candidate Profile
• University degree (B.Pharm, M.Pharm or Pharm.D) or Medical Professional
• 6-7 years experience of working in Regulatory, Clinical Operations or Medical Affairs) within the pharmaceutical industry. Ideally having minimum 4 years of experience working in Pharmacovigilance.
Additional Information
Experience : 6-7 years experience
Qualification : B.Pharm, M.Pharm or Pharm.D
Location : Mumbai
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Patient Safety
End Date : 5th July 2025
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