="text-align: center;">Safety Data Management Specialist – at Pfizer, Apply Now!
Looking to grow your career in pharmacovigilance? Pfizer is hiring an Associate – Safety Data Management Specialist for its dynamic safety team. This hybrid role offers the opportunity to work on end-to-end case processing, including narrative writing, regulatory compliance, and safety database management. If you’re a Pharm.D, B.Pharm, or M.Pharm graduate with 1–2 years of ICSR experience, this could be your gateway to an impactful future in drug safety.
Job Title: Associate – Safety Data Management Specialist at Pfizer
Job Requisition ID: 4938187
About Pfizer:
Pfizer is a leading global pharmaceutical company dedicated to discovering, developing, and delivering innovative healthcare solutions. With a strong legacy in science and a commitment to patient well-being, Pfizer operates in over 150 countries and continues to drive breakthroughs that change lives.
Primary Responsibilities
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Carry out case processing activities
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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
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Review case criteria to determine appropriate workflow for case processing
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Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately
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Write and edit case narrative
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Determine and perform appropriate case follow-up, including generation of follow-up requests
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Review processed cases to verify accuracy, consistency, and compliance with process requirements, and review case data for special scenarios
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Liaise with key partners, locally, and other stakeholders regarding safety data collection and data reconciliation
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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
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Determine reportability of scheduled reports, ensuring adherence to regulatory requirements
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Consistently apply regulatory requirements and Pfizer policies
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Participate, as appropriate, in local, internal, and external safety activities
Here Is What You Need (Minimum Requirements):
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Education: B. Pharm, M. Pharm, or Pharm. D only
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Experience: Minimum 1 year, maximum 2 years
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End-to-End ICSR processing, including listedness assessment
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Ability to work collaboratively in a team environment
Bonus Points If You Have (Preferred Requirements):
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Hands-on experience in ARGUS safety database
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Proficiency with processing source documents in XML format (E2B R2 and R3)
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Good knowledge of medical terminology and global regulatory requirements for drug safety
Work Location Assignment:
Hybrid
Keywords: Pfizer, Safety Data Management Specialist, Job Posting, Pharmacist, Drug Safety Regulations, Hybrid Work, Pharma Industry
