This position is responsible for establishing the Company’s safety and pharmacovigilance (PV) strategy in conjunction with the Company’s development and commercial objectives. This includes leading all pre- and post-marketing safety, PV and risk management activities. The incumbent in this position must effectively interface cross-functionally at all levels in the organization as well as external regulatory authorities. The Director will have primary responsibility for management and oversight of a contracted pharmacovigilance outsourced vendor and planning for an in-house group. They will be responsible for managing global pharmacovigilance and risk management activities while ensuring that these activities are in full compliance with internal policies as well as with all applicable regulatory requirements. This role guides internal governance processes and cross functional activities related to safety and supervises external contractual relationships covering pharmacovigilance and risk management. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.
• Responsible for oversight of global drug safety processes and activities
• Responsible for management of external vendors
• Responsible for Adverse Event reporting operations
• Oversee the quality of all drug safety programs and drug safety deliverables
• Directs the medical assessments of all adverse event findings to the regulatory authorities, including but not limited to individual case safety reports (ICSRs), INDs, NDAs, annual report summary statements, and Periodic or Developmental Safety Update Reports (PSURs/DSURs).
• Directs the creation and maintenance of company core safety information
• Responsible for all processes and operating procedures to ensure compliance with appropriate regulations and quality standards
• Responsible for drug safety surveillance and ensures safety of drug development activities in compliance with regulatory requirements and company standard operating procedures
• Provides input to the generation of individual Safety Data Exchange agreements (SDEAs)
• Drives safety updates and initiatives based on data from signal detection, clinical practice, or scientific research.
• Serves as the expert for risk-benefit evaluations for any applicable RiskMAPs/REMS obligation and guides risk management plans for development and commercial products.
• The Director is also responsible for hiring, training, and management of safety operations staff
• Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents
• Keeps abreast of new safety regulations and guidance from the regulatory authorities
• Provides guidance with adverse event and drug coding, serious adverse event collection and analysis.
• Provides leadership and guidance during internal and external safety audits.
• Oversees and guides remediation of any Pharmacovigilance deficiencies cited during regulatory or internal audits.
• Prepares and reviews safety section of IB, Protocols, Clinical Reports, and NDA submissions
• BS required. MPH, MS, other advanced science degree preferred. Ten (+) years of pharmacovigilance experience with global product responsibility
• Demonstrated ability to utilize effective critical thinking and problem-solving skills
• Effective collaboration with other departments
• Communicates effectively to management across departments
• Ability to manage multiple tasks with deadlines in a fast-paced working environment
• Experience in regulatory requirements and guidelines pertaining to drug safety
• High attention to detail and accuracy
• Demonstrated cross-functional teamwork, verbal and written communication skills
• Strong commitment to business ethics