[한국화이자제약] Drug Safety Unit - Safety Data Management Specialist

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.

ROLE SUMMARY:

Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer’s products and to meet regulatory requirements. Determination of local submission of individual and, where appropriate, aggregate safety reports.

ROLE RESPONSIBILITIES:

• • Carry out case processing activities

• Review, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments

• Review case criteria to determine appropriate workflow for case processing

• Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately

• Write and edit case narrative

• Determine and perform appropriate case follow-up, including generation of follow-up requests

• Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios

• Liaise with key partners, locally , and other stakeholders regarding safety data collection and data reconciliation

• Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database

• Determine reportability of scheduled reports , ensuring adherence to regulatory requirements

• Consistently apply regulatory requirements and Pfizer policies

• Participate, as appropriate, in local, internal and external safety activities

QUALIFICATIONS:

• • Bachelor's Degree

• Fluency in Korean & English is required (both speaking & writing)

• Health Care Professional or equivalent experience preferred

• Ability, with supervision, to solve routine problems and to surface issues constructively

• Ability to make basic decisions with an understanding of the consequences

• Ability to achieve personal objectives while meeting departmental standards of performance

• Ability to work under supervision in a matrix organization

• Experience in pharmacovigilance and/or data management preferred but not required

• Experience and skill with medical writing an advantage

• Demonstrated computer literacy

• Experience in use and management of relational databases preferred

• Preferred: 1–2 years of experience in pharmacovigilance or clinical research

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