Pfizer
Associate - Safety Data Management Specialist
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The Associate Safety Data Management Specialist processes Individual Case Safety Reports, validates cases, and ensures compliance with pharmacovigilance regulations.
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The Aggregate Report Analyst Manager creates and oversees documents related to post-marketing safety data, ensuring compliance with regulatory standards and collaborating with project teams to resolve issues and improve processes.
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
Pfizer Chennai, Tamil Nadu, IND Office
Chennai, India
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