Senior Medical Director, Drug Safety and Pharmacovigilance, International

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Requirements:

• Medical Degree
• Requires at least 12 years of drug safety and pharmacovigilance experience (clinical trials safety experience in the biotechnology, pharmaceutical, drug safety contract service organization (CSO)) with at least 3 years of oversight management experience (line management or CSO management)
• Extensive experience with Regulatory submissions for NDAs, EU MAAs, and other countries’ Regulatory reviews; experience in Canada, Brazil and Australia preferred
• FDA and EMA, but also other regulatory bodies (e.g. Anvisa, Health Canada...) inspection experience for new approvals
• Growing a clinical trial drug safety system into a global post-marketing PV system
• Extensive experience with all aspects safety signal evaluation, including review and analysis of data, collaboration with cross functional team members and senior management, authoring of required regulatory correspondence, and safety label updates.
• Extensive experience in both clinical development and post-marketing safety
• Demonstrated ability to successfully manage drug safety team or drug safety CSO for a postmarketing program with responsibilities for expedited reporting, on-time PBRER preparation
• Extensive experience in leading drug safety audits and acting as lead SME for global agency inspections
• Extensive experience with managing internal and partner compliance with Pharmacovigilance Agreements and Safety Data Exchange Agreements
• Intimate knowledge of GCP and strong working knowledge of FDA, Good Clinical Practices, and ICH regulations and guidelines
• Proven ability to collaborate successfully with postmarketing teams, including medical affairs, biostats, regulatory, medical writing, and QA
• Experience in managing all postmarketing safety aspects of product quality defect investigations and assessments
• Management of compliance deviations and formulation of CAPAs
• Familiar with clinical trial safety database use and CIOMS II and PBRER reporting generation (Argus, ArisG, or VeevaSafety) and Microsoft Office Suite required (Word, Excel, PowerPoint, Project, Outlook)
• Intimate knowledge of GCP and strong working knowledge of FDA or other agencies, EU Good Clinical Practices, and ICH regulations and guidelines

Responsibilities:

• Oversee and understand all aspects of the assigned product’s safety profile from clinical development to post-approval safety surveillance, including management of contract service organizations and partners that provide safety data.
• Hosts and performs pharmacovigilance safety audits across assigned international partner organisations and markets.
• Ensures compliance with pharmacovigilance regulatory requirements across assigned international partner organisations and markets.
• Present data to the Safety Management Committee for designated product(s), and be responsible for identifying any emerging safety trends, defining the safety profile, and recommending safety actions based upon cumulative safety data.
• In collaboration with regulatory, clinical development, medical affairs, and business partners, establish the safety strategy for postmarketing safety, core safety information, local labeling, safety reporting, benefit-risk evaluation, risk management, engagement with regulatory authorities, and authoring of responses to inquiries.
• Co-manages the PV agreements and compliance of all assigned local distribution organizations and for compliance tracking for all safety submissions across all drug safety functions of the local distribution organizations.
• Co-manages ongoing reconciliation of incoming safety information and the safety databases.
• Acts as co-liaison with external collaborators to develop processes to meet regulatory reporting requirements.
• Participate in publication preparation and medical information material review.
• Manage medical aspects of aggregate data analysis, presentation of medical analyses internally and to regulatory agencies as required, expedited case analyses, scientifically sound PBRER preparation, and ensure the signal management and risk management functions of the contract service organizations meet corporate goals and key performance indicators and maintain the audit trail of activities ready for inspection at all times.
• Ensure compliance of the medical review of adverse event reports, manage preparation and submission of drug safety expedited and periodic reporting in compliance with multiple country regulations.
• Develop and present assessments of safety data, safety signals, benefit and risk for internal senior management as well as external partner or regulatory authorities.
• Assist in authoring of aggregate reports.
• Accountable for partner liaison aspects of signal management and risk management (GVP Modules)
• Co-manage the implement of pharmacovigilance SOPs and ensure the uniform and timely processing of adverse event data in all assigned development and post-marketing programs.
• Supports ad hoc safety review meetings, including all internal and external stakeholders, with compliance with signal evaluation timelines, and maintain audit trail as inspection ready at all times.
• When requested, work with other BridgeBio Affiliates to provide strategic input and work on assigned non-product/compound-related projects.