Document Reviewer

Title: Medical Reviewer.

Location: Remote (East Coast ONLY).

Contract: 12 Months.

Pay Range: $50.00/ Hr to $55.00/ Hr on W2

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

Responsibilities:

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

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.
• 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.

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