Secura Bio Careers

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Director — Drug Safety and Pharmacovigilance Operations

Job Description

Secura Bio is seeking a highly motivated individual to join us as Director – Drug Safety and Pharmacovigilance Operations. This position is responsible for the oversight of drug safety and pharmacovigilance (DSPV) activities for Secura Bio. In this role, the Director – DSPV Operations, provides leadership, direction and oversight to the company’s pharmacovigilance vendors, monitors vendor case processing activities, ensures regulatory and partner distribution compliance, monitors safety trends and signal detection and manages Risk Evaluation and Mitigation Strategy (REMS) requirements. The Director – DSPV Operations will also oversee the accurate and timely submission of Periodic Safety Reports and REMS assessment reports.

Responsibilities (include but are not limited to):

  • Oversight of DSPV case processing vendor including, but not limited to:
    • Database set up and functionality
    • Individual Case Safety Report (ICSR) case processing
    • Due diligence follow-up
    • Regulatory and partner ICSR submission compliance
    • Regulatory Safety Update Reporting
  • Oversight of the REMS vendor including:
    • Stakeholder communications (physician, patient, professional societies)
    • Assessment report requirements
  • Creation and maintenance of Standard Operating Procedures
  • Attending and supporting 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
  • Advanced knowledge of ICH, EMA and FDA legislation and regulations in both clinical and post-marketing settings
  • 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.