Pfizer Pharmacovigilance Job Openings in Chennai Location

safety surveillance associate

location : India – Chennai

Job Description :

• 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.

How You Will Achieve It

• Contribute to completion of project milestones and organize own work to meet project task deadlines.
• Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission.
• Support Worldwide Strategy and Regulatory teams by providing analyses of post-marketing safety data, reviews of the medical literature, and similar related activities.
• Review case criteria to determine the appropriate workflow for case processing.

Qualifications

Must-Have

• Bachelor’s Degree

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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Tagged as: Global Pharma Jobs, Good Clinical Practice (GCP), Pharmaceutical Careers, Pharmaceutical Jobs