Sr. Director – Drug Safety & Pharmacovigilance

Sr. Director – Drug Safety & Pharmacovigilance

Requirements

• A bachelor’s degree in a health care discipline or equivalent is required, and an advanced degree is preferred
• Requires at least ten years of drug safety and pharmacovigilance experience (clinical trials safety experience in the biotechnology, pharmaceutical, drug safety contract service organization (CSO)) with at least three years of oversight management experience (line management or CSO management)
• Experience in both clinical development and post-marketing safety
• Experience with Regulatory submissions for NDAs, EU MAAs, and other countries’ Regulatory reviews
• QPPV service management and oversight, PSMF authoring experience
• FDA and EMA inspection experience for new approvals
• Growing a clinical trial drug safety system into a global post-marketing PV system
• Demonstrated ability to successfully manage a drug safety team or a drug safety CRO for a clinical program with responsibilities for expedited reporting, on-time DSUR preparation, and meeting corporate goals and key performance indicators
• Safety signal evaluation, management, and tracking, including supporting regulatory documentation
• Experience in drug safety audits and agency inspections, as case processing, DSUR, and CSO management as a subject matter expert
• Intimate knowledge of GCP and strong working knowledge of FDA, Good Clinical Practices, and ICH regulations and guidelines, and the demonstrated ability to manage drug safety and pharmacovigilance regulatory requirements during the conduct of 2 or more clinical trials
• Experience in working with clinical trial teams, including data management, clinical sciences, medical monitors, clinical operations, biostats, regulatory, medical writing, and QA
• Experience with drug safety and clinical trial aspects of clinical trial design, protocol development and review, CRF and SAE Form preparation, site initiation visit safety reporting slide preparation, and training
• Experience in investigating and managing potential product quality defects
• Management of compliance deviations and formulations of CAPAs
• Post-marketing labeling experience as it pertains to safety
• Familiar with clinical trial safety database use and CIOMS II and DSUR reporting generation (Argus, ArisG, or VeevaSafety) and Microsoft Office Suite required (Word, Excel, PowerPoint, Project, Outlook)
• Must be able and willing to travel periodically

Responsibilities

• Manage all aspects of safety and pharmacovigilance for assigned products to ensure a compliant and sound safety strategy in both clinical trials and the post-marketing setting
• Assists in the assessment of safety data and safety signals for internal Safety Management Committee DMCs, DSURs, IBs, CSRs, CSR SAE narratives, CCSIs, product labeling, RMPs, new drug applications, safety label updates, and other reports as necessary
• Support the clinical development team in the review of critical documents, including protocols and ICFs
• Manage the drug safety contract service organizations (CSOs) for clinical programs with >=95% compliance with expedited reporting, manage on-time and scientifically sound DSUR preparation, and ensure the drug safety functions of the CSOs meet corporate goals and key performance indicators
• Assist in the medical review of severe adverse event reports; manage the preparation and submission of drug safety expedited reporting in compliance with regulations, when necessary
• Develop and prepare assessments of safety data, safety signals, and benefits/risks for internal senior management, as well as external partners or regulatory authorities
• Assist in the authoring of aggregate reports
• Manages the drug safety CROs for SAE case processing and for compliance tracking for all safety submissions across all drug safety functions of the CROs
• Works with data management in the ongoing reconciliation of clinical and safety databases
• Acts as a liaison with external collaborators to develop processes to meet regulatory reporting requirements
• Develops and prepares reports for company management as well as external regulatory agencies
• Ensure compliance with standard operating procedures and clinical trial and post-market global drug safety regulations, including to the FDA, EMA, MHRA, and other RAs
• Implement pharmacovigilance SOPs and ensure the uniform and timely processing of adverse event data in all assigned development and post-marketing programs
• Manage the drug safety contract service organizations (CSOs) for clinical programs with >=95% compliance with expedited reporting, manage on-time and scientifically sound DSUR preparation, and ensure the drug safety functions of the CSOs meet corporate goals and key performance indicators
• When requested, work with other BridgeBio Affiliates to provide strategic input and work on assigned non-product/compound-related projects

Preferred Qualifications

No preferred qualifications provided.