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Safety Surveillance Associate

0.00 to 4.00 Years   Chennai (Tamil Nadu)   14 May, 2025
Pfizer
Job LocationChennai (Tamil Nadu)
EducationAny Graduate
SalaryAs per Industry Standards
IndustryHealthcare
Functional AreaBio Tech/R&D/Scientist
EmploymentTypeFull-time

Job Description

  • Organizational Relationship(s) including to whom the position reports: Case Processing Team Lead
  • Position Purpose: Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizers 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.
  • Qualifications (i.e., preferred education, experience, attributes):
    • 0-4 years experience in Pharmacovigilance/ Clinical research/ Hospital practice / Teaching etc.
    • Mandatory minimum bachelors in health care degree (i.e., dentistry, pharmacy, nursing, or equivalent).
Work Location Assignment: HybridPfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.#LI-PFELocations - IND - Chennai Office

Keyskills :
adverse drug reporting case processing workflow regulatory compliance knowledgemedical writing experiencedatabase management pharmacovigilance research regulatory requirements clinical clinical research clinical development pharmacy

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