Job title: Medical Reviewer (Pharmacovigilance)
Company: Artech Information Systems
Job description: Job Title: Medical Reviewer (Pharmacovigilance)
Location: Remote//Nutley, NJ
Duration: 12+ Months (Possible Extension)
Type: ContractInitially can be remote but may need to come into the office for trainings and meetings.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
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%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
Expected salary:
Location: Nutley, NJ
Job date: Sat, 09 Nov 2024 01:55:33 GMT
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