Pfizer Associate I, Safety Assessment in Shanghai, R&D Center, China

Position Purpose

  • Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer's products and to meet regulatory requirements.

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.

Technical Skill Requirements

  • 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.

N: Not Applicable - 不适用 (China)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.