Sr. Director, Drug Safety & Pharmacovigilance

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
 
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.

What You'll Do

The Sr. Director, 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 determine the safety strategy.

Responsibilities

• Manage all aspects of safety and pharmacovigilance for assigned products to ensure a compliant and sound safety strategy in both clinical trials and the post-marketing setting
• Assists in the assessment of safety data and safety signals for internal Safety Management Committee DMCs, DSURs, IBs, CSRs, CSR SAE narratives, CCSIs, product labeling, RMPs, new drug applications, safety label updates, and other reports as necessary
• Support the clinical development team in the review of critical documents, including protocols 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 DSUR preparation, and ensure the drug safety functions of the CSOs meet corporate goals and key performance indicators
• Assist in the medical review of severe adverse event reports; manage the preparation and submission of drug safety expedited reporting in compliance with regulations, when necessary
• Develop and prepare assessments of safety data, safety signals, and benefits/risks for internal senior management, as well as external partners or regulatory authorities
• Assist in the authoring of aggregate reports
• Manages the drug safety CROs for SAE case processing and for compliance tracking for all safety submissions across all drug safety functions of the CROs
• Works with data management in the ongoing reconciliation of clinical and 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 other RAs
• Implement pharmacovigilance SOPs and ensure the uniform and timely processing of adverse event data in all assigned development and post-marketing programs
• Manage 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
• When requested, work with other BridgeBio Affiliates to provide strategic input and work on assigned non-product/compound-related projects

Where You'll Work

• This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco, CA office.

Who You Are

• A 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 (clinical trials 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
• QPPV service management and oversight, PSMF authoring experience
• FDA and EMA inspection experience for new approvals
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