Business Services & Consulting • all cities, VT 47
Remote - USA
Mavericks Wanted
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 andpromising 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.At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.
The VP of Drug Safety will be responsible for managing all aspects of the drug safety functions of the CROs and will be an integral part of the Safety Management Team. In addition, they will be responsible for collaborating with Clinical Operations, QA, Clinical Research, Regulatory Affairs, Medical Information/Liaisons, and Medical Writing for investigational compounds across the company. Responsibilities can grow to include marketed product safety and pharmacovigilance when appropriate.
Contribute to and lead a full range of pharmacovigilance (PV) activities for investigational products, including operational activities, cross-functional activities with other departments, quality systems, audits, and inspections
Direct drug safety management oversight (clinical study case process flow, reconciliation with clinical database) for specific clinical trials, as requested
Manage oversight of external activities by vendors (CROs), including case processing, expedited safety reporting, and partner data exchange. The successful candidate will be responsible for oversight of safety operations strategy, including case management, database strategy, vendor oversight, compliance, inspection readiness, contracts, and training
Lead Safety section of submission documents
Participate and/or lead presentations with Regulatory Authorities
Participate and/or lead meetings with consultants and investigators
Participate and/or lead advisory panel meetings
Contribute to and review safety data exchange agreements with alliance partners and safety management documentation for studies managed under an alliance, as applicable
Develop proactive risk management strategies for investigational compounds
Provide updates of the assigned drug's safety profile to senior management and recommend pharmacovigilance/risk management activities
Contribute to and review investigator's brochures, safety sections of clinical study protocols, single and aggregate expedited reports, areas of regulatory submissions, or regulatory responses (including IRBs or Ethics Committees)
Plan, manage/perform and monitor all pharmacovigilance activities for assigned drug responsibilities, including:
Provide company causality assessments
Provide clinical input in signal detection and perform signal evaluation activities
Provide a clinical (drug safety) perspective at Safety Management Committee meetings
Participate in Bridgebio Safety Board when requested
Maintain currency with applicable PV global regulations and industry guidelines
Oversee preparation, development, implementation, and maintenance of company standard operating procedures and policies relating to pharmacovigilance and risk management to ensure compliance with ICH guidelines and applicable regulatory requirements
Contribute to inspection readiness activities
Develop strategies to further enhance and optimize the impact of the Drug Safety and PV department
This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.
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
$420,000 - $460,000 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
Health & Well-Being
Skill Development & Career Paths:
Remote - USA
Mavericks Wanted
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 andpromising 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.At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.
The VP of Drug Safety will be responsible for managing all aspects of the drug safety functions of the CROs and will be an integral part of the Safety Management Team. In addition, they will be responsible for collaborating with Clinical Operations, QA, Clinical Research, Regulatory Affairs, Medical Information/Liaisons, and Medical Writing for investigational compounds across the company. Responsibilities can grow to include marketed product safety and pharmacovigilance when appropriate.
Contribute to and lead a full range of pharmacovigilance (PV) activities for investigational products, including operational activities, cross-functional activities with other departments, quality systems, audits, and inspections
Direct drug safety management oversight (clinical study case process flow, reconciliation with clinical database) for specific clinical trials, as requested
Manage oversight of external activities by vendors (CROs), including case processing, expedited safety reporting, and partner data exchange. The successful candidate will be responsible for oversight of safety operations strategy, including case management, database strategy, vendor oversight, compliance, inspection readiness, contracts, and training
Lead Safety section of submission documents
Participate and/or lead presentations with Regulatory Authorities
Participate and/or lead meetings with consultants and investigators
Participate and/or lead advisory panel meetings
Contribute to and review safety data exchange agreements with alliance partners and safety management documentation for studies managed under an alliance, as applicable
Develop proactive risk management strategies for investigational compounds
Provide updates of the assigned drug's safety profile to senior management and recommend pharmacovigilance/risk management activities
Contribute to and review investigator's brochures, safety sections of clinical study protocols, single and aggregate expedited reports, areas of regulatory submissions, or regulatory responses (including IRBs or Ethics Committees)
Plan, manage/perform and monitor all pharmacovigilance activities for assigned drug responsibilities, including:
Provide company causality assessments
Provide clinical input in signal detection and perform signal evaluation activities
Provide a clinical (drug safety) perspective at Safety Management Committee meetings
Participate in Bridgebio Safety Board when requested
Maintain currency with applicable PV global regulations and industry guidelines
Oversee preparation, development, implementation, and maintenance of company standard operating procedures and policies relating to pharmacovigilance and risk management to ensure compliance with ICH guidelines and applicable regulatory requirements
Contribute to inspection readiness activities
Develop strategies to further enhance and optimize the impact of the Drug Safety and PV department
This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.
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
$420,000 - $460,000 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
Health & Well-Being
Skill Development & Career Paths:
