Oversee the assessment of medical safety information including single cases and aggregate safety data for Catalyst Pharmaceuticals' developmental and marketed products. Lead signal detection and benefit/risk management activities and contribute to the development of pharmacovigilance strategies for monitoring the safety profile of the company’s products. Lead collaborations with external partners as well as with other functions within Catalyst Pharmaceuticals, including Clinical Development, Regulatory Affairs, Medical Affairs, or the commercial organization to ensure that drug safety communications are accurate, complete and consistent.

Duties & Responsibilities

To include but not limited to the following:

  • Manage the Medical Drug Safety process and identify system and resource needs to ensure quality and compliant medical safety evaluations
  • Perform risk management and benefit-risk evaluation for clinical and post marketing programs
  • Provide strategic leadership to improve the consistency and accuracy of medical assessments
  • Perform general safety signal management methodologies and product specific signaling strategies
  • Prepare aggregate safety data reviews and the preparation of the medical content of periodic reports (including PSURs, DSURs) and ad-hoc reports
  • Ensure that the safety profiles of products are accurately and consistently represented in relevant labeling documents, identify and prepare updates as required
  • Lead the preparation and delivery of high quality, consistent, and compliant safety information for regulatory (including IND and NDA) submission documents
  • Prepare relevant medical sections of responses to safety related health authority requests, various clinical documents including Investigator’s Brochures, clinical protocols, safety management plans, study reports, and integrated analyses
  • Oversee and contribute to the preparation of safety for products developed and/or commercialized with external partners
  • Perform medical review of individual case safety reports
  • Actively interact with external customers and service
  • Develop and/or update relevant procedural documents including SOPs, Work Instructions, forms or templates
  • Provide medical safety expertise for internal and external audits and regulatory authority inspections for Pharmacovigilance and ensure that relevant corrective actions are implemented
  • Maintain an up-to-date working knowledge of applicable regulatory requirements, guidelines, and industry standards globally

Basic Qualifications

  • M.D. degree required
  • Minimum 4-5 years of relevant experience in the pharmaceutical/biotech industry in the areas of pharmacovigilance including safety signal management and benefit-risk assessment
  • Demonstrated ability to analyze and present complex pharmacovigilance data
  • Experience authoring medical evaluations and contributing to regulatory submissions
  • Strong competency in understanding the scientific background of disease mechanisms and medical therapies
  • Understanding of global pharmacovigilance regulatory requirements and guidance documents
  • Excellent leadership, communication and organizational skills
  • Ability to think strategically and communicate complex issues clearly
  • Knowledge of safety databases (e.g. Aris G, Argus) and E2B filing

Preferred Qualifications

  • US Board Certified or eligible preferred
  • Experience in global drug development including epidemiology, clinical research, medical affairs or other relevant field
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