Safety Data Management Specialist

Role Summary

Safety Data Management Specialist at Pfizer. Responsible for monitoring drug, biologics, and medical device surveillance programs, including intake, evaluation, and processing of adverse reports; supporting clinical trials and post-marketing activities; and ensuring regulatory compliance in safety data management.

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, guidelines, Standard Operating Procedures, data entry conventions, and 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.

Qualifications

• Must-Have:
  • Bachelor's Degree in Health or Life Sciences
  • Ability, with supervision, to solve routine problems and surface issues constructively
  • Ability to make basic decisions with an understanding of the consequences
  • Ability to achieve personal objectives while meeting departmental standards of performance
  • Ability to work under supervision in a matrix organization
  • Demonstrated computer literacy
  • Fluency in spoken and written English
• Nice-to-Have:
  • Health Care Professional or equivalent experience preferred
  • 1+ years' experience in pharmacovigilance and/or data management preferred
  • Experience and skill with medical writing an advantage
  • Experience in use and management of relational databases preferred

Skills

• Regulatory knowledge and compliance
• Safety data management and pharmacovigilance
• Medical writing and case narrative development
• Data reconciliation and database proficiency
• Communication with stakeholders

Education

• Bachelor's Degree in Health or Life Sciences

Additional Requirements

• Hybrid work arrangement requiring on-site presence ~2.5 days per week within commuting distance.