Safety Data Management Specialist

Safety Data Management Specialist SGS_JOB_3501 Business Support New Jersey Pharmacovigilance Safety Case Processing Adverse Event Reporting Medical Writing Regulatory Compliance Safety Databases Data Management Contract - 12 Months (Possibilities of Extension) Location (mandatory): Parsippany, NJ 07054 The Safety Data Management Specialist is responsible for reviewing, processing, and reporting adverse drug experience data to support the safety profile of Pfizer's products and ensure compliance with regulatory requirements. The role involves case processing, data verification, safety reporting, and collaboration with internal and external stakeholders.

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.