Vice President, Drug Safety, Pharmacovigilance

Job reputed company: • 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 company • Strong interpersonal skills including verbal and written communication. Benefits: • Comprehensive medical, dental, reputed company insurance • 401k plan • Unlimited reputed company time off • Parental leave Apply tot his job Apply To this Job