Medical Reviewer - Must have MD

New Jersey  ‐ Onsite
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Keywords

Description

Responsibilities
  • 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 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 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.
SKILLS

MUST BE A DOCTOR OF MEDICINE.

Critical skills required:
good medical knowledge; sound medical judgement; good communication skills; and ability to prioritize/good organizational skills. Experience using MS Word desired.

Synectics is an Equal Opportunity Employer.
Start date
n.a
From
Synectics
Published at
03.07.2013
Project ID:
561144
Contract type
Freelance
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