job title: Spec, PV(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 withing 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 preferre