01Requirements
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 To this Job Company : reputed company Salary : Work from home Apply To This Job .
