Job Title: Associate Safety Data Management Specialist
Location: Hybrid
Experience Level: 0 to 2 years
Job Summary:
* Responsible for end-to-end case processing activities, including review, verification, and documentation of safety data.
* Ensure compliance with global regulatory requirements and internal corporate policies.
* Collaborate with local and international stakeholders to maintain data integrity and reconciliation.
* Manage case workflows, including identifying complexities and determining appropriate follow-up actions.
* Requires a pharmacy degree (B. Pharm, M. Pharm, or Pharm. D) and a strong understanding of drug safety principles.
Role Overview
At Pfizer, our Worldwide Medical and Safety department plays a critical role in bridging scientific evidence with healthcare stakeholders. Our mission is to empower informed medical decisions regarding the safe and effective use of our medicines. As an Associate Safety Data Management Specialist, you will be at the heart of this process, ensuring that safety information is meticulously gathered, processed, and analyzed to protect patient health. We are looking for a detail-oriented professional who is passionate about pharmacovigilance and dedicated to maintaining the highest standards of data integrity.
Primary Responsibilities
In this role, you will manage various aspects of Individual Case Safety Report (ICSR) processing. Your daily duties will include:
Case Processing and Documentation: You will review, rank, and verify case-related information, including event terms, seriousness, and special scenarios. You will be responsible for ensuring that all data is accurate, consistent, and documented in accordance with established timelines.
Workflow Management: You will evaluate incoming case criteria to determine the most effective processing workflow. This involves distinguishing between standard cases and those with increased complexity, ensuring that critical safety issues are identified and escalated to the appropriate teams when necessary.
Narrative Development: You will be responsible for writing and editing clear, concise, and accurate case narratives that capture the full scope of the safety event.
Communication and Follow-up: You will determine when additional information is required for a case and initiate the appropriate follow-up requests. Furthermore, you will serve as a point of contact for internal and local stakeholders to ensure seamless data collection and reconciliation.
Quality and Compliance: You will review processed cases to verify adherence to internal Standard Operating Procedures (SOPs) and global regulatory guidelines. It is essential that you maintain deep expertise in current industry regulations, data entry conventions, and safety database search functions to ensure continuous compliance.
Reporting and Strategy: You will analyze the reportability of scheduled safety reports, ensuring that all submissions meet regulatory deadlines. You will also participate in local and global safety activities to contribute to the broader goals of the department.
Required Qualifications
To be successful in this role, you must meet the following minimum criteria:
* Educational Background: You must hold a degree in Pharmacy (B. Pharm, M. Pharm, or Pharm. D).
* Experience: We are seeking candidates with 0 to 2 years of relevant experience.
* Technical Knowledge: A solid understanding of ICSR processing is required.
* Soft Skills: You must possess the ability to work effectively and collaboratively within a diverse team environment.
Preferred Qualifications
While not mandatory, the following qualifications will be highly regarded:
* Technical Proficiency: Hands-on experience working with the ARGUS safety database.
* Data Standards: Demonstrated experience processing source documents in XML format, specifically complying with E2B R2 and R3 standards.
* Regulatory Knowledge: A strong grasp of medical terminology and an in-depth understanding of global regulatory requirements regarding drug safety and pharmacovigilance.
Work Environment and Culture
Pfizer is committed to fostering a professional, inclusive, and forward-thinking environment. This position is based in a hybrid work model, offering a balance between collaborative in-office engagement and the flexibility of remote work.
As an equal opportunity employer, Pfizer complies with all applicable employment legislation. We believe that a diverse workforce is essential to achieving our goal of bringing life-changing therapies to patients. We encourage applicants from all backgrounds who are dedicated to the pursuit of excellence in medical safety and patient care to apply for this position.
Joining our team means contributing to a global effort to improve health outcomes through evidence-based decision-making. If you are a pharmacy graduate looking to start or advance your career in the pharmaceutical industry with a focus on patient safety, we invite you to apply and contribute your expertise to our mission.