Senior Director, Drug Safety and Pharmacovigilance

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 to the 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

This a U.S-based remote role that will require 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

At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.

Salary$250,000—$289,000 USD

As a global company, our comprehensive benefits may vary based on location. We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.

For Full-Time U.S Based Roles

Financial & Rewards

Market-leading compensation

401(k) with employer match

Employee Stock Purchase Program (ESPP)

Referral bonus for hired candidates

Subsidized lunch and parking on in-office days

Health & Well-Being

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)