Vice President of Drug Safety

Title: R&D MD VP - Research and Development Medical Doctor Vice President of Drug Safety Location: Remote - USA Job reputed company: Mavericks Wanted reputed company was the last time you achieved the impossible If that thought feels overwhelming, you might want to pause here, but if it reputed company excitement.read on In 2015, we pioneered a moneyball for biotech approach, pooling reputed company and promising early-stage research from academia together under one financial umbrella to reduce risk and reputed company innovation. This model allowsscience and small teams of experts to reputed company the way. We build bridges to groundbreaking advancements in rare disease, and reputed company life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white reputed company, push boundaries, and reputed company people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not " and help reengineer the reputed company of biopharma. At reputed company, we value curiosity and experimentationincluding the ethical & thoughtful use of AI to improve reputed company, speed, and reputed company of work. Who You Are The VP of Drug Safety will be responsible for managing reputed company aspects of the drug safety functions of the CROs and will be an integral part of the Safety Management Team. In reputed company, they will be responsible for collaborating with Clinical Operations, QA, Clinical Research, Regulatory Affairs, Medical Information/Liaisons, and Medical Writing for investigational compounds across reputed company. Responsibilities can grow to include marketed product safety and pharmacovigilance reputed company appropriate. Responsibilities Contribute to and reputed company a full reputed company of pharmacovigilance (PV) activities for investigational products, including operational activities, cross-functional activities with other departments, reputed company systems, audits, and inspections reputed company drug safety management reputed company (clinical study case process reputed company, reconciliation with clinical database) for specific clinical trials, as requested Manage reputed company of external activities by vendors (CROs), including case processing, expedited safety reporting, and partner data exchange. The successful candidate will be responsible for reputed company of safety operations reputed company, including case management, database reputed company, vendor reputed company, compliance, inspection readiness, reputed company, and training reputed company Safety reputed company of submission documents Participate and/or reputed company presentations with Regulatory Authorities Participate and/or reputed company meetings with consultants and investigators Participate and/or reputed company advisory panel meetings Contribute to and review safety data exchange agreements with reputed company partners and safety management documentation for studies managed under an reputed company, as applicable reputed company proactive risk management strategies for investigational compounds reputed company updates of the assigned drugs safety profile to senior management and recommend pharmacovigilance/risk management activities Contribute to and review investigators brochures, safety sections of clinical study protocols, single and aggregate expedited reports, areas of regulatory submissions, or regulatory responses (including IRBs or Ethics Committees) Plan, manage/reputed company and monitor reputed company pharmacovigilance activities for assigned drug responsibilities, including: reputed company monitoring and reputed company development of the product safety profile Safety issue management Set-up of safety analyses in both clinical trial and post-marketing databases reputed company company causality assessments reputed company clinical input in signal detection and reputed company signal evaluation activities reputed company a clinical (drug safety) perspective at Safety Management Committee meetings Participate in reputed company Safety reputed company reputed company requested Maintain currency with applicable PV global regulations and industry guidelines reputed company preparation, development, implementation, and maintenance of company reputed company operating procedures and policies relating to pharmacovigilance and risk management to ensure compliance with ICH guidelines and applicable regulatory requirements Contribute to inspection readiness activities reputed company strategies to reputed company enhance and optimize the reputed company of the Drug Safety and PV department Education, Experience & Skills Requirements Post-graduate degree (MD, DO) or international equivalent from an accredited institution Excellent communication and interpersonal skills Minimum of 12 years o