Associate Safety Data Management Specialist

Pfizer

Freshers years

Preffered by Company

Chennai

Not Disclosed May 13, 2024

Job Description

Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D Skills: ICSR Case Processing

Associate - Safety Data Management Specialist

Application Information

Locations: India - Chennai
Time Type: Full-time
Posted On: Posted 2 Days Ago
Job Requisition ID: 4908042

Job Responsibilities

Case Processing Activities

Review, rank, verify, process, and document case-related information, including:
- Event terms
- Validity
- Seriousness
- Special scenarios
- Timelines
- Accuracy and consistency
Process cases based on these assessments
Review case criteria to determine the appropriate workflow for case processing
Assess cases to identify complexities and specific issues, escalating appropriately
Write and edit case narratives
Determine and perform appropriate case follow-up, including generating follow-up requests
Review processed cases to verify accuracy, consistency, and compliance with process requirements; review case data for special scenarios

Liaison and Expertise Development

Liaise with key local partners and stakeholders regarding safety data collection and data reconciliation
Develop and maintain expertise and knowledge for applicable corporate and global regulations, guidelines, Standard Operating Procedures, data entry conventions, and search functions in the safety database

Reportability and Regulatory Adherence

Determine the reportability of scheduled reports, ensuring adherence to regulatory requirements
Consistently apply regulatory requirements and Pfizer policies

Participation in Safety Activities

Participate, as appropriate, in local, internal, and external safety activities

Qualifications & Experience

Required

B. Pharm. / M.Pharm. / Pharm D graduates
2-3 years of experience in ICSR case processing
Freshers with relevant skills are also eligible

Must Have

Meticulous attention to detail and accuracy
Good written communication skills
Analytical and problem-solving skills
Proficient in medical terminology
Knowledge of ICSR processing guidelines and regulations

Nice to Have

Knowledge of event assessment
Working experience in the ARGUS database

Work Location Assignment

On Premise

Additional Information

All elements of your compensation, including the value of non-monetary perquisites, will be subject to deduction of applicable tax at source, as required by the Income-tax Act, 1961.
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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