Senior Director, Drug Safety and Pharmacovigilance

Das ist der Job

Accountable for maintaining AE intake from global data sources including Organized Data Collection Systems.

Darum lohnt es sich

Responsibilities The primary responsibilities are to manage safety contract service organizations (CSOs) with ≥95% compliance with clinical and postmarket safety regulations (including FDA, EMA, MHRA, and all assigned international RAs), processes, PV agreements, and database management.

Benefits Market-leading compensation 401(k) with employer match Employee Stock Purchase Program (ESPP) Pre-tax commuter benefits (transit and parking) Referral bonus for hired candidates Subsidized lunch and parking on in-office days 100% employer-paid medical, dental, and vision premiums for you and your dependents Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA) Fertility & family-forming benefits Expanded mental health support (therapy and coaching resources) Hybrid work model with flexibility Flexible, "take-what-you-need" paid time off and company-paid holidays Comprehensive paid medical and parental leave to care for yourself and your family Skill development and career paths: opportunities for growth within the company, including internal mobility and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching. #J-18808-Ljbffr Senior Director, Drug Safety and Pharmacovigilance Remote - USA Salary: $250,000 – $289,000 USD What You’ll Do Accountable for maintenance of post market and clinical trial pharmacovigilance data systems for ICSR handling, periodic reporting, and safety inspection readiness.

Oversee safety CSOs for postmarket programs to achieve global safety systems to meet corporate goals and key performance indicators. Develop and prepare assessments of global safety data analyses for internal senior leadership as well as external partner or regulatory authorities. 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. Where You’ll Work U.S.-based remote role that requires quarterly or as needed visits to our San Francisco Office.

Who You Are Bachelor’s degree in a health care discipline or equivalent is required, and an advanced degree is preferred. Requires at least 12 years of drug safety and pharmacovigilance experience (post-market safety experience in the biotechnology, pharmaceutical, drug safety contract service organization (CSO)).

Requires at least three years of PV business management of safety systems leading maintenance and regulatory agency inspections. Demonstrated history of self-direction and accountability, demonstrated during Inspection history. Experience with regulatory submissions for PSUR, PBRER, RMP; experience in US, EU Canada, Brazil, Australia preferred.

Experience in both clinical trial and post-marketing safety required. Direct participation in agency inspections including FDA, EMA, Health Canada and others. Management of change management, compliance deviations, and CAPAs.

Expertise with clinical trial and post market safety database use, management, and change control (Argus, ArisG, and/or VeevaSafety) and Microsoft Office Suite required (Word, Excel, PowerPoint, Project, Outlook). Must be able and willing to travel.