Medical Director, Drug Safety

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Industry: Scientists / Research / Lab Technician
Job Number:

Title: Medical Director, Drug Safety

Location: Remote

Job Type: Long Term Contract

 

Job Description:

  •  Responsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, the identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products.
  • Manage safety surveillance for assigned compounds / products.
  • Manage collection, in cooperation with a PV scientist, of current data for safety signalling and identify and investigate safety signals.
  • Conduct analysis of safety data.
  • Provide safety strategic leadership for clinical development programs / program teams.
  • Integrate the safety scientific component to build a strategic framework for clinical development plans.
  •  Develop and maintain relationships with program counterparts in Clinical Development, Pre-Clinical Safety, Research, Regulatory, Clinical Operations, Clinical Pharmacology, Quantitative Sciences, Translational Sciences, Worldwide Medical.
  • Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal time frames and time frames dictated by regulatory authorities.

Required Skills:

  • Minimum 7 years’ experience in the pharmaceutical industry or clinical care setting.
  • Preferably has prior experience in pharmacovigilance or clinical development.
  • Knowledge of pre- and post- marketing US and EU regulations
  • Knowledge of clinical epidemiology/biostatistics or clinical pharmacology highly desirable.
  • Excellent communication skills (oral and written) and excellent organizational skills.

Education:

MD, or MD PhD, or MD MPH required; sub specialty training highly desirable

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