Director, Drug Safety

vor 4 Wochen

Zug, Schweiz BridgeBio Vollzeit

BridgeBio International Zug, Switzerland Pharmacovigilance

**About BridgeBio**:
**BridgeBio** is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 20+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.

Our focus on scientific excellence and rapid execution aim to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland.

**Who You Are**:
BridgeBio is expanding commercial operations across different regions worldwide, including LATAM, MENA and Asian-pacific markets through the partnering with local distribution organisations to support the launch of our asset in ATTR-CM. As part of that expansion, we are hiring a Director of Drug Safety, who will be responsible for managing all aspects of the drug safety functions related to the international markets and the BridgeBio partner organisations and will be an integral member of the Safety Management Team. In addition, you will be responsible for collaborating with Clinical Operations, QA, Clinical Research, Regulatory Affairs, and Medical Writing to determine safety strategy for all international expansion markets**.**

**Work Location**: Zug, Switzerland / Remote Switzerland & Netherlands

**Responsibilities**:

- Leads the pharmacovigilance agreement negotiation between BridgeBio and the local distribution organisations
- Leads the BridgeBio international pharmacovigilance safety management across all partner markets and in collaboration with the local distribution organisation
- Hosts and performs pharmacovigilance safety audits across all partner organisations and markets
- Ensures compliance with pharmacovigilance regulatory requirements across all partner organisations and markets
- Manage all aspects of safety and pharmacovigilance for assigned products to ensure compliant and sound safety strategy in both clinical trials and the post-marketing setting for the geography in scope
- Manages international critical documents, including protocol and ICFs
- Manage the drug safety contract service organizations (CSOs) for clinical programs with >=95% compliance with expedited reporting, manage 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 safety data, safety signals, and benefits/risks for internal senior management as well as external partner or regulatory authorities
- Manages the authoring of aggregate reports and other local safety reports as required
- 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
- Manages ongoing reconciliation of incoming safety information and the safety databases
- Acts as a liaison with external collaborators to develop processes to meet regulatory reporting requirements
- 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

The above job description documents the general nature and level of work but is not intended to be an exhaustive list of activities, duties, and responsibilities required of job incumbents. Therefore, job incumbents are expected to perform all other duties as assigned or required, as training and experience allow.

**No matter your role at BridgeBio, successful team members are**:

- Patient Champions, who put patients first and uphold strict ethical standards
- Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
- Truth Seekers, who are detailed, rational, and humble problem solvers
- Individuals Who Inspire Excellence in themselves and those around them
- High-quality executors, who execute against g

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