Job Description
Vacancy for Safety Data Management Specialist at Pfizer.
Job Title/Position:
Safety Data Management Specialist
Job Overview:
Job vacancy for Pharmacy
Job Location:
Chennai
What are the Key Responsibilities?
• Carry out case processing activities
• Review, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments
• Review case criteria to determine appropriate workflow for case processing
• Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately
• Write and edit case narrative
• Determine and perform appropriate case follow-up, including generation of follow-up requests
• Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios
• Liaise with key partners, locally , and other stakeholders regarding safety data collection and data reconciliation
• Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database
• Determine reportability of scheduled reports , ensuring adherence to regulatory requirements
• Consistently apply regulatory requirements and Pfizer policies
• Participate, as appropriate, in local, internal and external safety activities
What are the Educational Qualification(s) for this position(s)?
B.Pharm, M.Pharm, Pharm. D
Pharmacovigilance, Individual Case Safety Reports processing. Knowledge of ARGUS database preferable.
What is the Experience Required for this Job?
0 – 2 years.
Related:
Opportunity at Institute of Microbial Technology (IMTECH)
