Safety Surveillance Specialist

4 days ago

Metro Manila Philippines Buscojobs Full time

Job Title and Location

Safety Surveillance Associate — Makati, National Capital Region

Job Description

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.
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.

Work Location Assignment: Flexible

LI-PFE

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

Medical

LI-PFE

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