Safety Data Management Specialist

We're in relentless pursuit of breakthroughs that change patients' lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer's purpose – Breakthroughs that change patients' lives – we have established a clear set of expectations regarding "what" we need to achieve for patients and "how" we will go about achieving those goals.

Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

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 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.

Here Is What You Need (Minimum Requirements):

• BA/BS with any years of experience
• Strong analytical skills with the ability to interpret complex data
• Proficiency in using safety databases and software
• Excellent written and verbal communication skills
• Ability to work collaboratively in a team environment
• Basic understanding of regulatory requirements and corporate policies

Bonus Points If You Have (Preferred Requirements):

• Experience in pharmacovigilance or drug safety
• Familiarity with medical terminology and coding systems
• Knowledge of global regulatory requirements for drug safety
• Strong problem-solving skills and the ability to make decisions with limited information
• Proficiency in multiple programming languages and frameworks
• Experience with cloud platforms and services
• Familiarity with agile methodologies and project management tools

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 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.

Here Is What You Need (Minimum Requirements):

• BA/BS with any years of experience
• Strong analytical skills with the ability to interpret complex data
• Proficiency in using safety databases and software
• Excellent written and verbal communication skills
• Ability to work collaboratively in a team environment
• Basic understanding of regulatory requirements and corporate policies

Bonus Points If You Have (Preferred Requirements):

• Experience in pharmacovigilance or drug safety
• Familiarity with medical terminology and coding systems
• Knowledge of global regulatory requirements for drug safety
• Strong problem-solving skills and the ability to make decisions with limited information
• Proficiency in multiple programming languages and frameworks
• Experience with cloud platforms and services
• Familiarity with agile methodologies and project management tools

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.