Job Description
Sr. Director/Safety Scientist, Pharmacovigilance Operations Remote - USA Overview Sr. Director/Safety Scientist, Pharmacovigilance Operations In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries, and empower 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 future of biopharma. Affiliate Overview ML Bio, an affiliate within BridgeBio Pharma, is developing BBP-418 (ribitol), an investigational oral therapy for the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9), a rare genetic neuromuscular disease caused by mutations in the FKRP gene. BBP-418 is designed to address the underlying disease biology by supplying ribitol to support proper glycosylation of α-dystroglycan, which is critical for muscle integrity and function. The program has received Orphan Drug Designation from the U.S. Food and Drug Administration and the European Medicines Agency, as well as Fast Track and Rare Pediatric Disease Designations from the U.S. FDA. Topline interim results from the Phase 3 FORTIFY study have been publicly reported and support the ongoing clinical development of BBP-418. BBP-418 continues to be evaluated in global registrational clinical studies with the intent to bring a potential therapy to patients affected by this serious rare disease. What You’ll Do • Oversight and understanding of all aspects of the assigned product’s safety profile from clinical development to post-approval safety surveillance, including management of CROs and other partners that provide clinical and safety data • Facilitate Safety Management Committee for designated product(s), responsible for identifying any emerging safety trends, defining the safety profile, and recommending safety actions based upon cumulative safety data • In collaboration with the regulatory and clinical development team, establish the safety strategy for marketing authorization applications, including the preparation of CTD documents, engagement with regulatory authorities, and authoring responses to inquiries Responsibilities • Support the clinical development team in the review of key documents, including protocols and informed consent forms (ICFs) • Manage drug safety contract research organizations (CROs) for clinical programs to ensure compliance with expedited reporting requirements, on-time and scientifically sound DSUR preparation, and alignment with corporate goals and KPIs • Assist in the medical review of adverse event reports; manage preparation and submission of expedited safety reports in compliance with global regulations, when necessary • Develop and prepare assessments of safety data, safety signals, and benefit-risk evaluations for internal senior management as well as external partners and regulatory authorities • Assist in the authoring of aggregate safety reports Where You’ll Work This is a U.S.-based remote role that will generally require up to three visits per year, or as needed, to our San Francisco office. Who You Are • Bachelor’s degree in a healthcare discipline or equivalent is required; an advanced degree is preferred • Minimum of ten years of drug safety and pharmacovigilance experience, including at least five years in clinical development safety • Extensive experience with all aspects of safety signal evaluation, including data review and analysis, cross-functional collaboration, authoring regulatory correspondence, and safety label updates • Experience in both clinical development and post-marketing safety • Experience with regulatory submissions for NDAs, EU MAAs, and other global regulatory reviews is highly preferred • Experience in drug safety audits and regulatory agency inspections • Intimate knowledge of GCP and strong working knowledge of FDA regulations, ICH guidelines, and global pharmacovigilance requirements • Proven ability to collaborate successfully with clinical trial teams, including data management, clinical sciences, medical monitoring, clinical operations, biostatistics, regulatory affairs, medical writing, and quality assurance • Experience managing clinical safety aspects of product quality defect investigations and assessments • Familiarity with clinical trial safety databases and CIOMS II and DSUR reporting (e.g., Argus, ArisG, or Veeva Safety) and proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Project, Outlook) Rewarding Those Who Make the Mission Possible We have high expectations for our team members and ensure
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