PSSR-Associate I, Safety Assessment_Japanese

Primary Responsibilities

• Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays.
• Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately.
• Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness/listedness/labeledness); special scenarios; product complaint information; reportability with due date; and accuracy and consistency. Based on assessment of cases, process accordingly.
• Review case criteria to determine the appropriate workflow for case processing.
• Write and edit the case narrative.
• Generate reports, ensuring adherence to regulatory compliance timelines.
• Determine appropriate case follow-up, requesting follow-up letters when appropriate.
• Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and data reconciliation.
• Develop and maintain expertise and knowledge of all products within the Pfizer portfolio; applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practices; data entry conventions; and search functions in the safety database.
• Consistently apply regulatory requirements and Pfizer policies.

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• Experience in pharmacovigilance, in clinical care, or in clinical or scientific research is an advantage but not a requirement.
• Demonstrated computer literacy, particularly in the use and management of relational databases.
• Ability to achieve personal objectives while meeting departmental standards of performance.
• Ability to work under supervision in a matrix organization.
• Excellent oral and written communication skills.
• Fluency in spoken and written English; knowledge of additional language(s) an advantage.
• Experience and skill with medical writing an advantage.

• Ability, with supervision, to solve routine problems and to surface issues constructively.
• Ability to make basic decisions with an understanding of the consequences.
• Bachelor's degree in a science-related field, pharmacy, nursing, or equivalent; healthcare professional qualification preferred.
• Japanese skill equal to N2 or above.