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Reference Number:
PZ2867MedRW
Job Description:
Please send resume at dave@sunrisesys.com with Job id - PZ2867MedRW in the subject line.
If you are available; please include your complete name, location, availability, contact information and 2 professional references in the body of the email along with word copy of the resume.
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Job id - PZ2867MedRW
Client - Pharma Company
Title - Medical Reviewer
Location - NY/NJ/PA
Duration - 12 Months
Rate - Open
THERE ARE 6 POSITIONS WITH THE HIRING MANAGER. TELECOMMUTE IS OKAY
Medical Degree is required.
- Critical skills: good medical knowledge; sound medical judgment; good communication skills; able to prioritize/good organizational skills
- F2F meeting required (1 hour)
- Site interview will be with a panel of interviewers
- Degree: ONLY Doctor of Medicine candidates will be sent on to the Manager
- OT is possible, but must have prior approval by management before working
Medical Reviewer Job Description
? Conduct review and assessment of serious spontaneous reports of adverse events and perform causality assessment of clinical trials and solicited reports
? Determine regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion
? Perform triage on cases and determine seriousness and relatedness across products/sites as assigned
? Acquire and maintain current knowledge of product portfolio and safety profiles for products across DSS therapeutic teams as appropriate
? Escalate complex case issues on team product(s) to the Medical Director of the therapeutic team as appropriate
? Conduct assessment of litigation cases across products/sites as assigned
? Review and provide assurance of medical content and clinical relevance of regulatory safety documents including Investigators? Brochures, PSURs and ad hoc regulatory reports as assigned
? In collaboration with the Medical Director, assist in pharmacovigilance activities through active follow-up of cases to obtain additional information as assigned
? Identify and resolve case issues, coordinate with therapeutic teams/site for specific products or functional groups across DSS as appropriate
? Communicate and interact effectively within and across Therapeutic Teams, and within Functional Team Management as appropriate
? Acquire and maintain knowledge of applicable Global Health Authority regulations
Experience Level:
3 Years
Requirements:
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