Safety Data Management Specialist (Temporal 12 Meses)

Use Your Power for Purpose
Our mission is straightforward: empower healthcare decisions regarding the safe and appropriate use of medicines for patients. Whether you are developing the framework to ensure our evidence is scientifically robust, providing unbiased and medically essential expertise, or exploring ways to bridge data gaps, your role is vital. By ensuring our evidence is sound and offering necessary medical insights, we strive to improve patient care and treatment efficacy.
What You Will Achieve
In this role, you will:

• Monitor and manage the company's drug, biologics, and medical devices surveillance program, ensuring comprehensive oversight.
• Intake, evaluate, and process adverse reports for both clinical trials and post-marketing activities, ensuring accurate and timely handling.
• Act as a subject matter expert, liaising with key partners regarding safety data collection, reconciliation, and ensuring regulatory compliance.
• Review, analyze, prepare, and complete safety-related reports to determine the safety profile of products and meet regulatory requirements.
• Verify the accuracy, consistency, and compliance of processed cases, and review case data for special scenarios, ensuring high standards are maintained.
• Manage safety resources within the local team, provide specific pharmacovigilance or product knowledge, mentor colleagues, and maintain advanced knowledge of Pfizer's product portfolio and corporate policies.

Here Is What You Need (Minimum Requirements)

• Bachelor's Degree in Health Science
• 3+ years' experience
• Demonstrated organizational/project management skills
• Solid knowledge of global regulations and guidelines for drug development
• Demonstrated analytical and statistical skill.
• Ability to make decisions independently and resolve issues appropriately
• Strong skills in productivity, organizational and time management in order to meet strict regulatory compliance goals
• Fluent in spoken and written English

Bonus Points If You Have (Preferred Requirements)

• Master's degree
• Relevant pharmaceutical industry experience
• Familiarity with management of performance metrics
• Strong problem-solving skills
• Proficiency in safety database and data mart search functions
• Fluent in other languages

Work Location Assignment: Hybrid
EEO (Equal Employment Opportunity) & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.
Medical
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