This role involves case processing, reviewing case information, and ensuring compliance with regulatory requirements. It also includes liaising with stakeholders and developing expertise in safety data management.
Primary Responsibilities
Here Is What You Need (Minimum Requirements):
Bonus Points If You Have (Preferred Requirements):
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
#LI-PFE
- 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.
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
#LI-PFE
Top Skills
Argus Safety Database
XML
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