Safety Surveillance Associate
Pfizer Canada Inc.
Makati City, PHL
18d ago

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 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.
  • Qualifications

  • 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.

    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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