Associate Safety Data Management Specialist

Pfizer

Freshers years

Preffered by Company

Chennai

Not Disclosed May 13, 2024

Job Description

Job Type: Full Time Education: B.Pharm/M.Pharm/PharmD Skills: ICSR Case Processing

Case Processing Activities

Review, Rank, Verify, Process, and Document Case-Related Information:
- Event terms
- Validity
- Seriousness
- Special scenarios
- Timelines
- Accuracy and consistency
Process Cases Based on Assessments:
- Determine appropriate workflow for case processing
- Assess cases for complexities and specific issues; escalate appropriately

Narrative and Follow-Up

Write and Edit Case Narrative
Determine and Perform Appropriate Case Follow-Up:
- Generate follow-up requests

Case Review and Compliance

Review Processed Cases:
- Verify accuracy, consistency, and compliance with process requirements
- Review case data for special scenarios

Liaison and Expertise Development

Liaise with Key Partners:
- Local partners and stakeholders
- Safety data collection and data reconciliation
Develop and Maintain Expertise:
- Corporate and global regulations
- Guidelines and Standard Operating Procedures
- Data entry conventions
- Search functions in the safety database

Reportability and Regulatory Adherence

Determine Reportability of Scheduled Reports:
- Ensure adherence to regulatory requirements
Apply Regulatory Requirements and Pfizer Policies Consistently

Participation in Safety Activities

Participate in Local, Internal, and External Safety Activities as Appropriate

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
Proficiency 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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