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 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); spuniquecenarios; product complaint information; reportability with due date; and accuracy and consistency. Based on an 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 reconciliation.
• Develop and maintain expertise and knowledge of all products within the Pfizer portfolio, applicable corporate and global regulations, guidelines, Standard Operating Procedures, 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 project milestone completion and organize work to meet project task deadlines.
• Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission.
• Provide support to the Worldwide Strategy and Regulatory teams by analyzing post-marketing safety data, reviewing the medical literature, and performing related activities.
• Review case criteria to determine the appropriate workflow for case processing.

Qualifications

Qualifications (i.e., preferred education, experience, attributes)

• Minimum a bachelor’s degree in healthcare professional qualification (ie, Pharmacy, Dentistry, Nursing etc).
• 0–3-years’ experience in pharmacovigilance/ related domains.

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