Senior Manager, Drug Safety - San Francisco, United States - BridgeBio Pharma, Inc.

Description

About BridgeBio

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers.

We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients.

Founded in 2015, the company has built a portfolio of 20+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.

Our focus on scientific excellence and rapid execution aim to translate today's discoveries into tomorrow's medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.

To learn more about our story and company culture, visit us at

Who You Are

The Senior Manager, Drug Safety & Pharmacovigilance will be responsible for managing all aspects of the drug safety functions of the CROs and will be an integral member of the Safety Management Team.

In addition, you will be responsible for collaborating with Clinical Operations, QA, Clinical Research, Regulatory Affairs, and Medical Writing to support drug safety operations.

Responsibilities

• Manages the drug safety contract service organizations (CSOs) for clinical programs with >=95% compliance with expedited reporting, manage on-time and scientifically sound DSUR preparation, and ensure the drug safety functions of the CSOs meet corporate goals and key performance indicators
• Assist with inspection readiness
• Safety document management in Trial Master File and Veeva
• Serves as the BridgeBio point of contact for the CSO to manage day-to-day safety-related activities
• Acts as a liaison with CSOs and external collaborators to develop processes to meet regulatory reporting requirements
• Collaborates with the CSO to develop and maintain the safety management plan for clinical trials and post-marketing safety activities
• Designs end-to-end process for CSO handling of individual case safety reports (ICSRs)
• Ensure compliance with standard operating procedures and clinical trial and post-market global drug safety regulations, including to the FDA, EMA, MHRA, other regulatory authorities
• Monitors the safety mailbox for assigned affiliates
• Manage and review the safety section of the electronic trial master file (eTMF) to ensure filing compliance and a constant audit-ready state
• Writes and maintains safety data exchange agreements (SDEAs) and pharmacovigilance agreements (PVAs) to ensure compliance with partner requirements
• Maintains internal safety and pharmacovigilance files to ensure an audit-ready state
• Collaborates with internal and external data management teams to implement electronic data capture (EDC)-based reporting of serious adverse events (SAEs) and adverse events of special interest (AESIs) including: case report form (CRF) design, edit check review, user acceptance testing (UAT), and management of the EDC alert process
• Works with data management for ongoing reconciliation of clinical and safety databases
• Provides safety-related updates in study management team (SMT) meetings
• Assists with data collection and review of safety data support the signal detection process in the clinical trial and post-marketing settings
• Provides input on safety-managed SOPs and other department initiatives
• When requested, works with other BridgeBio Affiliates to provide strategic input and work on assigned non product/compound related projects

No matter your role at BridgeBio, successful team members are:

• Patient Champions, who put patients first and uphold strict ethical standards
• Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
• Truth Seekers, who are detailed, rational, and humble problem solvers
• Individuals Who Inspire Excellence in themselves and those around them
• High-quality executors, who execute against goals and milestones with quality, precision, and speed

Education, Experience & Skills Requirements

• Bachelor's degree in a health care discipline or equivalent is required, and an advanced degree is preferred
• Requires at least three years of drug safety and pharmacovigilance experience (clinical trials safety experience in the biotechnology, pharmaceutical, drug safety contract service organization (CSO)) with at least one year of oversight management experience (line management or CSO management)
• Experience in both clinical development and post-marketing safety activities
• Experience with Regulatory submissions for NDAs, EU MAAs, and other countries' Regulatory reviews
• FDA and EMA inspection experience for new approvals
• Growing a clinical trial drug safety system into a global post marketing PV system
• Demonstrated ability to successfully manage drug safety team or drug safety CRO for a clinical program with responsibilities for expedited reporting, on-time DSUR preparation, and meeting corporate goals and key performance indicators
• Safety signal evaluation, management, and tracking, including supporting regulatory documentation
• Experience in drug safety audits and agency inspections as case processing, DSUR, and CSO management subject matter expert
• Intimate knowledge of GCP and strong working knowledge of FDA, Good Clinical Practices, and ICH regulations and guidelines, and the demonstrated ability to manage drug safety and pharmacovigilance regulatory requirements during the conduct of 2 or more clinical trials
• Experience in working with clinical trial teams, including data management, clinical sciences, medical monitors, clinical operations, biostats, regulatory, medical writing, and QA
• Experience with drug safety and clinical trial aspects of clinical trial design, protocol development and review, CRF and SAE Form preparation, and site initiation visit safety reporting slide preparation and training
• Management of compliance deviations and formulations of CAPAs
• Post-marketing labeling experience as it pertains to safety
• Familiar with clinical trial safety database use and CIOMS II and DSUR reporting generation (Argus,
• ArisG, or VeevaSafety) and Microsoft Office Suite required (Word, Excel, PowerPoint, Project, Outlook)
• Must be able and willing to travel periodically

What We Offer

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
• An unyielding commitment to always putting patients first. Learn more about how we do this here
• A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
• A place where you own the vision - both for your program and your own career path
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
• Access to learning and development resources to help you get in the best professional shape of your life
• Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
• Flexible PTO
• Rapid career advancement for strong performers
• Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
• Partnerships with leading institutions
• Commitment to Diversity, Equity & Inclusion