Mar 21, 2019

Safety Physician- Pharmacovigilance

  • RenaissancePhysician
  • Philadelphia, PA, USA
Full time Biotech Pharmaceutical

Job Description

Job Description:

This position is primarily responsible for providing medical support to all operational functions within the Safety Department and Clinical Operations, and supporting the Safety Manager, the Associate Director, and the Executive Director/Director.

Specific Job Duties:

  • Ensure that given timelines are met according to project and regulatory timelines
  • Process and evaluate AE reports according to the customer’s standard operating procedures (SOPs): write/review the narrative, perform seriousness rating and causality assessment
  • Perform medical review of individual cases or safety reports
  • Perform ICSR signal/trend detection
  • Perform Aggregate line listing signal/trend detection
  • Review SAE and AE coding to ensure medical accuracy with the verbatim reported term
  • Ensures medical and scientific input in study protocols and safety reports
  • Write/participate in writing safety reports (RMPs, PSURs, ARs, SBRs, Issue workups, annual reports…)
  • Provide medical input and medical monitoring in the clinical development process.

Requirements:

  • Qualified MD, DO
  • At least 2 years clinical practice experience in drug safety in pharmaceutical, biotech or CRO preferred
  • Some direct clinical research experience is preferred
  • Knowledge of relevant regulation and legislation
  • Fluent in English; additional languages a plus
  • Excellent written and verbal communication skills
  • Good interpersonal and presentation skills
  • Strong computer skills

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