Director, Drug Safety & Pharmacovigilance, International

Director, Drug Safety & Pharmacovigilance, International

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 aims 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.

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

BridgeBio is expanding commercial operations across different regions worldwide, including LATAM, MENA, and Asian-Pacific markets through partnering with local distribution organizations to support the launch of our asset in ATTR-CM. As part of that expansion, we are hiring a Director of Drug Safety, who will be responsible for managing all aspects of the drug safety functions related to the international markets and the BridgeBio partner organizations 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 determine safety strategy for all international expansion markets.

Responsibilities

• Leads the pharmacovigilance agreement negotiation between BridgeBio and the local distribution organizations.
• Leads the BridgeBio international pharmacovigilance safety management across all partner markets and in collaboration with the local distribution organization.
• Hosts and performs pharmacovigilance safety audits across all partner organizations and markets.
• Ensures compliance with pharmacovigilance regulatory requirements across all partner organizations and markets.
• Manage all aspects of safety and pharmacovigilance for assigned products to ensure compliant and sound safety strategy in both clinical trials and the post-marketing setting for the geography in scope.
• Manages international product labeling, RMPs, new drug applications, safety label updates, and other reports as necessary.
• Manages international critical documents, including protocol and ICFs.
• Manage the drug safety contract service organizations (CSOs) for clinical programs with >=95% compliance with expedited reporting, manage on-time and scientifically sound local safety report preparation, and ensure the drug safety functions of the CSOs meet corporate goals and key performance indicators.
• Develop and prepare assessments of safety data, safety signals, and benefits/risks for internal senior management as well as external partner or regulatory authorities.
• Manages the authoring of aggregate reports and other local safety reports as required.
• Manages the PV agreements and compliance of all assigned local distribution organizations and for compliance tracking for all safety submissions across all drug safety functions of the local distribution organizations.
• Manages ongoing reconciliation of incoming safety information and the safety databases.
• Acts as a liaison with external collaborators to develop processes to meet regulatory reporting requirements.
• Develops and prepares reports for company management as well as external regulatory agencies.
• Ensure compliance with standard operating procedures and clinical trial and post-market global drug safety regulations, including to the FDA, EMA, MHRA, and all assigned international RAs.
• Implement pharmacovigilance SOPs and ensure the uniform and timely processing of adverse event data in all assigned development and post-marketing programs.
• When requested, work with other BridgeBio Affiliates to provide strategic input and work on assigned non-product/compound-related projects.

The above job description documents the general nature and level of work but is not intended to be an exhaustive list of activities, duties, and responsibilities required of job incumbents. Therefore, job incumbents are expected to perform all other duties as assigned or required, as training and experience allow.

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 ten years of drug safety and pharmacovigilance experience (post-market safety experience in the biotechnology, pharmaceutical, drug safety contract service organization (CSO)) with at least three years of oversight management experience (line management or CSO management).
• Experience in both clinical development and post-marketing safety.
• Experience with Regulatory submissions for NDAs, EU MAAs, and other countries’ Regulatory reviews; experience in Canada, Brazil, and Australia preferred.
• QPPV service management and oversight, PSMF authoring experience.
• FDA and EMA, but also other regulatory bodies (e.g. Anvisa, Health Canada…) 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 clinical and post-marketing programs with responsibilities for ICSR collection, expedited reporting, on-time PSUR preparation, and meeting corporate goals and key performance indicators.
• Safety signal management, and tracking, including supporting regulatory documentation.
• Experience in drug safety audits and agency inspections as case processing, PSUR, and CSO management subject matter expert.
• Intimate knowledge of GCP and strong working knowledge of FDA or other agencies, Good Clinical Practices, and ICH regulations and guidelines.
• Experience in working with clinical trial and post-marketing teams, including data management, clinical sciences, medical monitors, clinical operations, biostats, regulatory, medical writing, medical liaisons, call center, and QA.
• Experience in investigating and managing potential product quality defects.
• 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 PSUR reporting generation (Argus, ArisG, or VeevaSafety) and Microsoft Office Suite required (Word, Excel, PowerPoint, Project, Outlook).
• Must be able and willing to travel up to 30%.

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.
• 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).
• Commitment to Diversity, Equity & Inclusion.

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