Safety Surveillance Associate

1 day ago

Makati City, National Capital Region, Philippines Pfizer Full time ₱1,500,000 - ₱3,000,000 per year

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 the appropriate workflow for case processing.

  • Write and edit the case narrative.

  • Generate reports, ensuring adherence to regulatory compliance timelines.

  • Determine and perform appropriate case follow-up, generating and requesting follow-up letters.

  • 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 assigned products within a therapeutic area; 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 Skills

  • 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.

Qualifications

  • 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.

Work Location Assignment: Hybrid

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

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