Medical Reviewer (Pharmacovigilance)

Initially can be remote but may need to come into the office for trainings and meetings.

Degree- MD required

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
1. Medical Review of Individual Safety Case Reports: 93%
2. Participates in the training of the Safety Specialists and Coordinators: 5%
3. Administration, Education and miscellaneous: 2%

Product 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
3+ 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