Medical Reviewer

MEDICAL REVIEWER

COMPANY INFO:

MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries.  We specialize in the nationwide recruitment of clinical trials personnel.

 

Our client is committed to earning the trust of doctors, patients and customers every day and is seeking to add a Medical Reviewer to their team in Kenilworth, NJ.

 

RESPONSIBILITIES:

" Reviews safety periodic reports, PSURs, narratives, and other safety-related documents and provides medical assessment/ judgment with respect to report contents.

" Ensures compliance and fulfillment of the requirements with respect to the evaluation, reporting, and surveillance of clinical and post marketing safety information.

" Ensures US drug safety reporting regulations, ICH guidelines, and internal procedures are applied to adverse event case reporting.

" Evaluates individual adverse event case reports and provides medical input with respect to the safety review of the adverse event cases.

" Provides guidance on the regulatory status for expedited reporting and/or signal detection/trends.

" Advises on safety-related medical and technical issues.

" Serves as a medical liaison between Global Pharmacovigilance and other Business Unit medical team members.

 

QUALIFICATIONS:

" Knowledge of industry regulations and drug safety practices.

" Strong knowledge of adverse event case report triage processing.

" Experience with commercial databases and safety coding dictionaries (MedDRA, WHOART, COSTART, etc.).

" Excellent oral and written communication and interpersonal skills.

" Experience working in a team environment.

" Strong skills in presenting drug safety topics at conventions, meetings, etc.

" Exposure to working relationship with FDA and other regulatory authorities is preferred.

" Knowledge and understanding of national and international regulatory guidelines are a plus

 

EDUCATION:

" M. D. degree required, with minimum of least 1 year in any of the following: PSURs, ASRs (Annual Safety Reports), or RMPs (Risk Management Plans)

 

MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.