Senior Medical Director, Drug Safety and Pharmacovigilance, International

Company Overview

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

Experienced safety physician who will lead the international safety strategy for your assigned products, working closely with highly motivated colleagues eager to bring safe, new treatments to patients.  This role requires a keen ability to work collaboratively, adapt and find solutions to complex problems, and drive results.  You will be responsible for comprehensive oversight and strategic oversight of core safety information and local labeling, postmarketing safety data review, benefit-risk assessment, risk management, and be a subject matter expert during agency inspections. You will be responsible for managing all aspects of the medical adverse event and aggregate safety data related to the international markets and the BridgeBio partner organisations 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.  You will also be responsible for medical safety/pharmacovigilance input and oversight of all international market submissions and related Regulatory queries.

Responsibilities

The Senior Medical Director is responsible for the overall risk management and safety strategy of assigned products, including both internal and external engagement with key collaborators.  The Senior Medical Director is expected to be the international medical safety expert for assigned products, independently write safety sections of international marketing applications, independently reply to agency requests, and represent BridgeBio on the international regulatory stage by meeting with and presenting to Regulatory Authorities during meetings and inspections (preapproval, pharmacovigilance, and ad hoc).  Travel is required.            

• Oversight and understanding of all aspects of the assigned product’s safety profile from clinical development to post-approval safety surveillance, including management of contract service organizations and partners that provide safety data.
• Hosts and performs pharmacovigilance safety audits across assigned international partner organisations and markets.
• Ensures compliance with pharmacovigilance regulatory requirements across assigned international partner organisations and markets.
• Present data to the Safety Management Committee for designated product(s), and be responsible for identifying any emerging safety trends, defining the safety profile, and recommending safety actions based upon cumulative safety data.
• In collaboration with regulatory, clinical development, medical affairs, and business partners, establish the safety strategy for postmarketing safety, core safety information, local labeling, safety reporting, benefit-risk evaluation, risk management, engagement with regulatory authorities, and authoring of responses to inquiries.
• Co-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.
• Co-manages ongoing reconciliation of incoming safety information and the safety databases.
• Acts as co-liaison with external collaborators to develop processes to meet regulatory reporting requirements.
• Participate in publication preparation and medical information material review.
• Manage medical aspects of aggregate data analysis, presentation of medical analyses internally and to regulatory agencies as required, expedited case analyses, scientifically sound PBRER preparation, and ensure the signal management and risk management functions of the contract service organizations meet corporate goals and key performance indicators and maintain the audit trail of activities ready for inspection at all times.
• Ensure compliance of the medical review of adverse event reports, manage preparation and submission of drug safety expedited and periodic reporting in compliance with multiple country regulations.
• Develop and present assessments of safety data, safety signals, benefit and risk for internal senior management as well as external partner or regulatory authorities.
• Assist in authoring of aggregate reports.
• Accountable for partner liaison aspects of signal management and risk management (GVP Modules)
• Co-manage the implement of pharmacovigilance SOPs and ensure the uniform and timely processing of adverse event data in all assigned development and post-marketing programs.
• Supports ad hoc safety review meetings, including all internal and external stakeholders, with compliance with signal evaluation timelines, and maintain audit trail as inspection ready at all times.
• 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

Where You’ll Work 

• Zug, Switzerland / Remote Switzerland

Who You Are

• Medical Degree
• Requires at least 12 years of drug safety and pharmacovigilance experience (clinical trials safety experience in the biotechnology, pharmaceutical, drug safety contract service organization (CSO)) with at least 3 years of oversight management experience (line management or CSO management)
• Extensive experience with Regulatory submissions for NDAs, EU MAAs, and other countries’ Regulatory reviews; experience in Canada, Brazil and Australia preferred
• 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
• Extensive experience with all aspects safety signal evaluation, including review and analysis of data, collaboration with cross functional team members and senior management, authoring of required regulatory correspondence, and safety label updates.
• Extensive experience in both clinical development and post-marketing safety
• Demonstrated ability to successfully manage drug safety team or drug safety CSO for a postmarketing program with responsibilities for expedited reporting, on-time PBRER preparation
• Extensive experience in leading drug safety audits and acting as lead SME for global agency inspections
• Extensive experience with managing internal and partner compliance with Pharmacovigilance Agreements and Safety Data Exchange Agreements
• Intimate knowledge of GCP and strong working knowledge of FDA, Good Clinical Practices, and ICH regulations and guidelines
• Proven ability to collaborate successfully with postmarketing teams, including medical affairs, biostats, regulatory, medical writing, and QA
• Experience in managing all postmarketing safety aspects of product quality defect investigations and assessments
• Management of compliance deviations and formulation of CAPAs
• Familiar with clinical trial safety database use and CIOMS II and PBRER reporting generation (Argus, ArisG, or VeevaSafety) and Microsoft Office Suite required (Word, Excel, PowerPoint, Project, Outlook)
• Intimate knowledge of GCP and strong working knowledge of FDA or other agencies, EU Good Clinical Practices, and ICH regulations and guidelines
• Must be able and willing to travel periodically for face-to-face engagements with regulatory authorities, and occasional on site meetings (if based remotely)

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