[Hiring] Director, Drug Safety & Pharmacovigilance @BridgeBio Pharma

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Director of Drug Safety will be responsible for managing all aspects of the drug safety functions related to US and assigned postmarketing data review and reporting.

• Manage the drug safety contract service organizations (CSOs) for postmarket pharmacovigilance with >=95% compliance with periodic reporting, signal management, and global risk management plans.
• Ensure 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 global safety data, signal management, and benefits/risks for internal senior management as well as external partner or regulatory authorities.
• Accountable for global periodic safety review and signal management meetings, and relationships with all internal and external stakeholders, maintaining an audit trail as inspection ready at all times.

Responsibilities

• Accountable for maintenance and inspection readiness of the quality management system for signal management (GVP Module IX.B.5) and PBRER preparation.
• Leads data collection for signal examination and assessment within timelines.
• Accountable for ad hoc safety review meetings, including all internal and external stakeholders, with 100% compliance with signal evaluation timelines, and maintain audit trail as inspection ready at all times.
• Manages the authoring of aggregate reports including PBRER and other local safety reports as required.
• Manages the authoring and collaboration with partner for global risk management plans.
• 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, maintaining audit trail as inspection ready at all times.
• Oversee the creation of periodic report and signal management reports, analysis, and presentation of safety data from the safety database, and maintain audit trail as inspection ready at all times.
• Manages ongoing reconciliation of incoming safety information and the safety databases.
• 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.

Qualifications

• 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 post-marketing safety, including clinical development preferred.
• Experience with Regulatory submissions for PSUR, PBRER, RMP, and other countries’ Regulatory reviews; experience in US, EU Canada, Brazil, Australia preferred.
• QPPV service management and oversight, PSMF authoring experience.
• Direct FDA and EMA, but also other regulatory bodies (e.g. Anvisa, Health Canada...) inspection experience.
• 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.

Benefits

• Market leading compensation.
• 401K with 100% employer match on first 3% & 50% on the next 2%.
• Employee stock purchase program.
• Pre-tax commuter benefits.
• Referral program with $2,500 award for hired referrals.
• Comprehensive health care with 100% premiums covered - no cost to you and dependents.
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions).
• Hybrid work model - employees have the autonomy in where and how they do their work.
• Unlimited flexible paid time off - take the time that you need.
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents.
• Flex spending accounts & company-provided group term life & disability.
• Subsidized lunch via Forkable on days worked from our office.
• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility.
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching.
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities.

Salary $220,000 — $320,000 USD Apply tot his job Apply To this Job