Associate - Safety Data Management Specialist

Use Your Power for Purpose
At Pfizer, our Worldwide Medical and Safety colleagues are pivotal in bridging evidence-based medical decision support with stakeholders to enhance health and treatment outcomes. Whether you are developing frameworks to ensure our evidence is scientifically robust, offering unbiased and medically essential expertise, or exploring ways to address data gaps, our mission remains clear: to empower healthcare decisions regarding the safe and appropriate use of medicines for patients.
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.
• Knowledge of ICSR processing.
• 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

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