Mar 21, 2019

Safety Physician

  • RenaissancePhysician
  • Cincinnati, OH, USA
Full time Biotech Pharmaceutical

Job Description

This position plays a key role in the pharmacovigilance process. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities

  • Execute medical review of case reports (narrative/coding review, expectedness/ causality assessment, company comment, medical query generation), both clinical trials and post-marketing.
  • Perform safety surveillance activities for investigational medicinal products
  • Author/review aggregate reports (e.g. DSURs, PSURs, PBRERs, PADERs)
  • Perform routine signal detection and safety surveillance/risk mitigation
  • Generate analysis of similar events for expedited reporting purposes
  • Author/review safety section of NDA filing documents
  • Participate in sponsor safety teleconferences
  • Participate in life-cycle management tasks
  • Collaborate with Medical Directors;
  • Provide oversight and key input for review of new or on-going safety documents;
  • Provide safety review of clinical study documents, including protocols, study reports; and marketing application components;
  • Collaborate with other departments to ensure appropriate collection and handling of safety data; and
  • Ensure regulatory compliance and safety throughout trial.

Qualifications/Requirements

  • MD Degree or equivalent;
  • Medical licensure; and
  • At least 4 years of clinical research experience.

Travel: Minimal


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