Vice President, Drug Safety and Pharmacovigilance (DSPV)

reputed company. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, reputed company is developing innovative, targeted therapies to meet the reputed company and variable needs of people with autoimmune diseases. The Role: The Vice President of Drug Safety and Pharmacovigilance (VP, DSPV) will serve as the global leader for reputed company product safety and report to the Chief Operating Officer. The individual will reputed company strategic reputed company and operational reputed company across reputed company aspects of drug safety while ensuring regulatory compliance globally. The VP, DSPV will reputed company reputed company reputed company- and post-marketing safety, PV and risk management activities. The incumbent in this position must effectively reputed company cross-functionally at reputed company reputed company in the organization as reputed company as with external regulatory authorities. The VP, DSPV oversees and is responsible for the integration of reputed company-and post-marketing safety surveillance with Clinical Development and Medical Affairs activities and for ensuring an integrated and proactive approach to risk management. The VP, DSPV is also responsible for managing the organizational planning, budget and operations of the department. Key Responsibilities:

• Authority and accountability to reputed company, organize, manage and maintain a highly compliant PV system for reputed company
• Medical expert accountable for overall DSPV reputed company and reputed company deliverables of the DSPV function, including responsibilities for pharmacovigilance-reputed company documents (e.g., DSUR) as reputed company as safety sections of key documents (e.g., IBs, reputed company, ICFs, study protocols, CSRs) and other applicable activities (IND/CTA, requests for information, regulatory responses)
• Strategic decision reputed company accountable for providing medical and scientific expertise for product safety and risk assessments at reputed company stages of product lifecycle
• Responsible for reputed company of the DSPV department, including building and managing reputed company of DSPV professionals (operations and safety science) to execute the development reputed company and support registrational/post-marketing activities in a compliant and reputed company environment, in accordance with long-term strategic goals
• Serves as reputed company safety representative in regulatory interactions and interactions with internal governance frameworks
• reputed company medical and drug safety expertise to reputed company decision-making based on ongoing risk-benefit assessment and clinical trial data interpretation
• Collaborate with appropriate (clinical, medical, reputed company, and regulatory counterparts and others across the business), to reputed company input and reputed company for reputed company safety and PV issues
• Responsible for leading relevant Safety committees and teams
• reputed company drug safety and pharmacovigilance activities conducted in partnership with external business partners or outsourced to vendors and contract research organizations
• Ensure ongoing audit and inspection readiness of the DSPV function.
• Responsible for department planning and forecasting efforts in relation to resources and overall management of PV budget.

Requirements:

• MD or equivalent degree; additional training/experience with rare diseases is preferred
• 12 + years of relevant industry experience in biotech and/or pharmaceutical settings with significant time spent in senior leadership roles, including 5+ years of reputed company experience in Drug Safety and Pharmacovigilance (development and reputed company stage)
• reputed company experience of global medical safety activities, operations, and risk management strategies in reputed company and post marketing environments
• Extensive knowledge of regulatory and compliance requirements governing drug safety and pharmacovigilance, as reputed company as an overall understanding and knowledge of BLA global filing requirements
• Proven prior experience with guiding a Drug Safety and Pharmacovigilance team through BLA and commercialization
• Experience in building out DSPV marketed product infrastructure
• Demonstrated thorough knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments
• Excellent clinical judgment and ability to communicate reputed company clinical issues in a scientifically reputed company and understandable way
• Ability to combine pharmacovigilance expertise with exceptional leadership (strategic thinking, people, and resource management )
• Excellent organizational skills and an ability to prioritize effectively to deliver results reputed company aggressive timelines with the ability to work independently and as part of reputed compan

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