Specialist, Pharmacovigilance (Baxter)

Roles and Responsibilities

Essential Duties and Responsibilities:

Process adverse event reports from all source types including review and full data entry of adverse event reports determining seriousness, expectedness, reporter’s causality and overall event resolution

Ensure that the correct suspect drug is selected within the Pharmacovigilance Safety System

Write narratives summarizing all relevant medical information for individual case safety reports

Code medical terms using standardized medical dictionaries (e.g., MedDRA)

Using medical expertise, ensure that all data has been entered and coded correctly in the database

Request case investigation to gather all required medical information, including query generation, tracking and follow up with reporters in conjunction with local affiliates

May perform quality checks as requested/necessary

May perform case clean-up as required for preparation of aggregate reports

Qualifications:

Medical and clinical knowledge

Excellent oral and written communication

Operates effectively in a team environment

Ability to work independently under strict deadlines and changing priorities with some supervision

Ability to multi-task and prioritize changing workload on a daily basis

Working knowledge of worldwide and regional safety regulations

Ability to establish proficiency working in the Pharmacovigilance Safety System

Education and/or Experience:

Degree in nursing, pharmacy, science degree or equivalent

Experience in the pharmaceutical industry (Regulatory or Safety) preferred

2-3 years of hospital, patient care or equivalent experience preferred