Job Description

Provides medical expertise in the review and evaluation of safety information for investigational and marketed products, including evaluation of serious clinical trial adverse events and spontaneous reports of adverse events

Assesses the relationship between drugs and adverse events

Evaluates case reportability per local regulatory requirements and meets appropriate timelines for case review

Participates in the training of the Safety Specialist and Coordinators

Essential Functions:

Responsibilities Percent of Time

Medical Review of Individual Safety Case Reports

Participates in the training of the Safety Specialists and Coordinators

Administration, Education and miscellaneous

Scope Measures

Collaborates with sub-group of health care professionals responsible for an aspect of case processing with emphasis on timely Medical Review and appropriate distribution and submission of case of cases to affiliates, partners and Regulatory Authorities

Responsible for the Causality Assessment for both, developmental and marketed product safety for Individual Case Safety Reports

Knowledge/Skills/Abilities Required

Health care professional degree required - MD

Over 5 years previous experience in Medical review

Knowledge of disease pathology and physiology, pharmacology and therapeutics

Knowledge of International and US Regulatory Requirements

Ability to work effectively in high paced and team environment.

Strong organizational, written and verbal communication skills

Previous experience using a Pharmacovigilance Database

Experience with quality assurance activities; attention to detail