Associate Safety Data Management Specialist (Pfizer)

Roles and Responsibilities

What You Will Achieve

In this role, you will:

• Monitor the company's 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 supervisor's 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, including risk management and ethical use.

Work Location Assignment: Hybrid