Head of Safety

  • 350000 USD - 400000 USD
  • San Francisco, United States
  • Permanent
VP, Pharmacovigilance
Remote Based
Pay Range: $380,000-$420,000

Meet are partnering with a mid-sized global biotech, who have line of sight towards their first BLA filing, to find their next Head of PV.
Working closely with the Executive Leadership Team you will be responsible for;
  • Establish and maintain oversight of safety vendor(s) day-to-day case processing activities, global ICSR submissions, case quality, KPIs, SAE reconciliations and study configurations in the global safety database.
  • Expertise to review and define the safety strategy for the BLA filings including, review of phase 3 protocol, review of ISS TLFs, review SCS and support CSR narrative template development or CSR narrative review
  • Provide support in periodic review of aggregate safety data for potential trends or signals in a timely manner.
  • Perform signal detection activities and analysis to support evaluation and characterization of safety topics.
  • Responsible for authoring, reviewing, and commenting on Safety Data Exchange Agreements/Pharmacovigilance Agreements with business partners.
  • Create, and maintain a safety quality management system and ensure a state of constant inspection readiness.
  • Responsible for hiring and providing managerial support to direct reports with overall responsibility of leading, training and mentoring for effective performance.
  • Serve as the Safety lead for audits and inspections. Responsible for identifying and following-up on corrective action plans and remediations.

Education and Background:
  • Medical degree
  • 10+ years experience in pharmacovigilance
  • Ability to identify and establish best practices for continuous improvement of case quality, compliance, and improvement.
  • Thorough knowledge of FDA, EMA, ICH guidelines and other global regulations.
  • Oncology experience is preferred.

To learn more about the position please contact sean@peoplewithchemistry.com, or contact 628-229-9023
Sean Farrell Division Director

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