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Safety Surveillance Associate

Pfizer
Pfizer
0-3 years
3-5 Lacs P.A.
10 Feb. 1, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm Skills: Communication Skills, Interpersonal Skill, Technical Skill
  • Organizational Relationship(s) including to whom the position reports (JD Job Title):

    Case Processing Team Lead

     

    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.

 

  • Qualification:
  • Bachelor's Degree in pharmacy, dental sciences or equivalent; healthcare professional qualification is mandatory.

  
Work Location Assignment: On Premise

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

Medical