Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.
Post : Associate - Safety Data Management Specialist
Job Description
• 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.
Candidate Profile
• B. Pharm./ M.Pharm. / Pharm D graduates with 2-3 years of experience in ICSR case processing
• Meticulous attention to detail and accuracy
• Good written communication skills
• Analytical and problem-solving skills
• Proficient in medical terminology
• Knowledge of ICSR processing guidelines and regulations
• Knowledge of event assessment
• Working experience in ARGUS database
Additional Information
Qualification : B.Pharm / M.Pharm. / Pharm.D
Experience : 2-3 years
Location : Chennai
Industry Type : Pharma
End Date : 31st March, 2024
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