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Director — Drug Safety and Pharmacovigilance Compliance and Training

Job Description

Secura Bio is seeking a highly motivated individual to join us as Director – Drug Safety and Pharmacovigilance Compliance and Training. This position is responsible for the individual case safety report and period safety report quality for Secura Bio. In this role, the Director, Drug Safety and Pharmacovigilance Compliance and Training ensures that the Drug Safety and Pharmacovigilance (DSPV) activities are performed with high quality and within regulatory, Safety Data Exchange Agreement and partner timelines.

Responsibilities (include but are not limited to):

  • Ensuring quality of DSPV deliverables:
    • Case processing
    • Safety Medical Writing
    • Literature Monitoring
    • Risk Management
    • Safety Data Exchange/ Safety Data Exchange agreements
  • Responsible for the creation and maintenance of the DSPV training matrix and contents
  • Responsible for the content, testing and tracking of DSPV training
  • Responsible for oversight of DSPV corrective and preventative actions
  • Responsible for the compliance to regulatory, partner and vendor timelines
  • Provide documentation and actively participate in regulatory inspections and audits

Basic Qualifications:

  • Bachelor’s Degree is required, Master’s degree preferred in a science or health-related field
  • A minimum of 8 years’ experience at increasing levels in Pharmacovigilance and Risk Management
  • Advanced knowledge of ICH, EMA and FDA legislation and regulations in both clinical and post-marketing setting
  • Experience with audits and inspections
  • Excellent written and verbal communication skills
  • Excellent interpersonal skills
  • Excellent presentation skills
  • Fluent in English

If you meet the requirements for this position, please email us at careers@securabio.com.