This role is part of the Safety Operations team within Global Patient Safety (GPS). As a team member, you will process individual case safety reports and serve as the case owner for adverse event reports, ensuring timely, accurate review, processing, quality control, and reporting.

Essential Duties and Responsibilities:

Process adverse event reports from various sources, including thorough data entry and assessment of seriousness, expectedness, causality, and overall resolution.
Accurately select the suspect drug within the Pharmacovigilance Safety System.
Write detailed narratives summarizing all relevant medical information for individual case safety reports.
Code medical terms using standardized medical dictionaries (e.g., MedDRA).
Ensure all data is entered and coded correctly in the database, leveraging your medical expertise.
Coordinate case investigations to gather necessary medical information, including query generation and follow-up with reporters in collaboration with local affiliates.
Perform quality checks and case clean-up as needed for aggregate report preparation.

Qualifications:

Medical and clinical knowledge.
Excellent oral and written communication skills.
Effective team collaboration.
Ability to work independently under tight deadlines and shifting priorities, with some supervision.
Strong multitasking and prioritization skills in a dynamic environment.
Familiarity with worldwide and regional safety regulations.
Proficiency in the Pharmacovigilance Safety System.

Education and Experience:

Degree in nursing, pharmacy, science, or a related field.
Experience in the pharmaceutical industry (regulatory or safety) is preferred.
2-3 years of experience in hospital or patient care settings is preferred.

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