Safety Data Management Specialist

Job Responsibilities:

• Reports to Country Safety Lead or Safety Team Lead or Safety Officer.
• Review, preparation, and completion of reports of adverse drug experiences to determine the safety profile of Pfizer’s products and meet regulatory requirements.
• Determine local submission of individual and, where appropriate, aggregate safety reports.
• Carry out case processing activities.
• Review, rank, verify, process, and document case-related information including event terms, validity, seriousness, special scenarios, timelines, accuracy, and consistency.
• Review case criteria to determine appropriate workflow for case processing.
• Assess cases to identify particular complexities or specific issues and escalate appropriately.
• Write and edit case narratives.
• 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, including review for special scenarios.
• Liaise with key partners locally and other stakeholders regarding safety data collection and data reconciliation.
• Develop and maintain expertise in applicable corporate and global regulations, guidelines, Standard Operating Procedures, data entry conventions, and safety database search functions.
• Determine reportability of scheduled reports and ensure adherence to regulatory requirements.
• Consistently apply regulatory requirements and Pfizer policies.
• Participate, as appropriate, in local, internal, and external safety activities.

Skills:

• Experience in pharmacovigilance and/or data management preferred but not required.
• Experience and skill in medical writing is an advantage.
• Demonstrated computer literacy.
• Experience in the use and management of relational databases preferred.

Education/Experience:

• Health Care Professional or equivalent experience preferred.
• Bachelor’s degree in a science discipline.
• Ability, with supervision, to solve routine problems and surface issues constructively.
• Ability to make basic decisions with an understanding of consequences.
• Ability to achieve personal objectives while meeting departmental performance standards.
• Ability to work under supervision in a matrix organization.
• Fluency in spoken and written English.