Senior Director, Drug Safety and Pharmacovigilance

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.

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.

Oversee safety CSOs for postmarket programs to achieve global safety systems to meet corporate goals and key performance indicators.

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

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.

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.