Associate - Safety Data Management Specialist @ Pfizer

Job Description

Primary 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

Here Is What You Need (Minimum Requirements):

• Education = B. Pharm, M. Pharm, or Pharm. D only.
• Minimum experience = 1 year. Maximum = 2 years.
• End to End ICSR processing, including listedness assessment.
• Ability to work collaboratively in a team environment.

Bonus Points If You Have (Preferred Requirements):

• Hands on experience in ARGUS safety database.
• Proficiency with processing source documents in XML format (E2B R2 and R3).
• Good knowledge of medical terminology and global regulatory requirements for drug safety.

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Keyskills:   Data management XML Reconciliation Standard operating procedures Data collection Database Case processing Drug safety Data entry