Associate Safety Data Management Specialist

Chennai - India

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Use Your Power for Purpose

At Pfizer our Worldwide Medical and Safety colleagues are pivotal in bridging evidence-based medical decision support with stakeholders to enhance health and treatment outcomes. Whether you are developing frameworks to ensure our evidence is scientifically robust offering unbiased and medically essential expertise or exploring ways to address data gaps our mission remains clear: to empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

What You Will Achieve

In this role you will:

Monitor the companys drug biologics and medical devices surveillance program.
Intake evaluate and process adverse reports for both clinical trials and post-marketing activities.
Make decisions within limited options to resolve problems under the supervisors direction.
Work in a structured environment following established procedures.
Ensure work is regularly reviewed for technical judgment completeness and accuracy.
Provide expertise on regulatory requirements and corporate policies for regulatory submissions to project teams.
Support Worldwide Strategy and Regulatory teams by analyzing post-marketing safety data reviewing medical literature and related activities.
Determine the appropriate workflow for case processing by reviewing case criteria.

In this pharmacovigilance role you will carry out processing activities of Individual Case Safety Reports (both clinical trials and post-marketing sources) in the ARGUS Safety database.

Processing activities include assessing case validity undertaking duplicate checks creating cases in the database prioritizing cases as per company guidance updating cases with information provided in XML source documents identifying adverse events confirming their seriousness coding products undertaking causality and listedness assessments drafting narratives determining appropriate case follow-up reviewing processed cases to verify technical judgment accuracy and compliance with company requirements etc.

Here Is What You Need (Minimum Requirements):

Education B. Pharm M. Pharm or Pharm. D only.

Experience 0 to 2 years ONLY please!

Keen attention to detail.

Solid analytical skills.

Good written and oral communication skills.

Collaborative skills.

Continuous Learning.

Bonus Points If You Have (Preferred Requirements):

Course completion and/or certification in Pharmacovigilance or good knowledge of medical terminology and global regulatory requirements for drug safety.

Publications in peer reviewed journals.

Experience using common AI tools including generative technologies such as ChatGPT or Microsoft Copilot to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices includingrisk management and ethical use.

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.

Medical

Required Experience:

Use Your Power for PurposeAt Pfizer our Worldwide Medical and Safety colleagues are pivotal in bridging evidence-based medical decision support with stakeholders to enhance health and treatment outcomes. Whether you are developing frameworks to ensure our evidence is scientifically robust offering u...