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Head of Risk Management Strategies

2 months ago

California, United States BioPhase Full time

-This is a hybrid position (3 days a week onsite) and candidates can be located in San Diego, CA -

The Director of Risk Management at BioPhase will lead the Risk Management System, encompassing the methodologies for signal detection, evaluation of safety issues, and spearheading risk management and epidemiological initiatives for both marketed and investigational products. This position guarantees that all risk management strategies and implementations are in accordance with US, EU, and international guidelines, regulations, and industry best practices.

Key Responsibilities:

  • Establish and oversee a comprehensive risk management framework for risk identification, evaluation, and mitigation across all products.
  • Act as a pivotal member of the safety signaling committee and other interdisciplinary teams, ensuring adherence to US, EU, and international regulations.
  • Supervise and manage safety-related committees, including Empirica and Topics, to ensure precise documentation and response to safety signals.
  • Lead the formulation and execution of Risk Management Plans (RMPs), including product-specific Risk Evaluation and Mitigation Strategies (REMS) and Periodic Benefit-Risk Evaluation Reports (PBRERs).
  • Provide leadership and collaboration in regulatory submissions, ensuring compliance with safety analysis requirements for marketed and investigational products.
  • Serve as an epidemiology subject matter expert, providing insights to internal teams and supporting clinical trial planning and safety risk evaluations.
  • Draft and maintain Standard Operating Procedures (SOPs) and work instructions related to risk management, epidemiology, and signal detection, ensuring adherence to best practices.
  • Support regulatory submissions such as Marketing Authorization Applications (MAA), New Drug Applications (NDA), and Biologic License Applications (BLA).
  • Manage safety-related committees, including the Signaling Committee, Executive Safety Committee, and Safety Evaluation and Risk Management (SERM) team.
  • Oversee and manage Empirica and Topics to ensure proper documentation of all safety signals.
  • Ensure comprehensive safety analysis and respond to regulatory inquiries, including PBRER assessment reports.
  • Direct and collaborate on the development of Risk Management Plans (RMPs/dRMPs) for both marketed and investigational products.
  • Draft SOPs and work instructions related to risk management, epidemiology, and signal detection.

Education/Experience/Skills Required:

  • Master's Degree in Public Health or a related field. A minimum of 10 years of progressive applied epidemiology experience in a regulated biotechnology or pharmaceutical industry is required, or a Ph.D. with 4 years of experience. Prior experience in Drug Safety and Risk Management is strongly preferred. An equivalent combination of relevant education and experience may be considered.

Key Skills:

  • In-depth knowledge of regulatory requirements and guidelines related to Drug Safety and Pharmacovigilance.
  • Proficiency in data mining activities for safety data analysis.
  • Experience in publishing original research in peer-reviewed journals and presenting at scientific meetings is preferred.
  • Proficiency in MS Office Suite.
  • Familiarity with standard desktop and pharmacovigilance computing programs such as Argus and Arisg is preferred.
  • Proficiency with Empirica/Topics, Spotfire, or other signal management tools is preferred.
  • Ability to apply relevant FDA, EU, and ICH guidelines, initiatives, and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments.