Job Description
Strategic Leadership:
- Lead strategic and operational activities for the PV department
- Build and oversee PV infrastructure, PV systems and PV processes to support safety data.
- Serve as the drug safety expert for regulatory submissions
Operational Excellence:
- Oversee the process for ICSR collection and reporting to ensure global standards.
- Develop and oversee the process for signal detection, evaluation, and management
- Lead vendor selection and provide vendor oversight for all outsourced PV activities
Compliance and Collaboration:
- Provide PV operational expertise in the development of RMPs, aggregate safety reports, REMS
- Responsible for the development and maintenance of Safety Management Plans and PV Agreement/Safety Data Exchange Agreement with license partners and distributors
-Contribute to safety sections of clinical study documents including Study Protocols, Informed Consent Forms (ICF), Clinical Study Reports (CSR), IB Reference Safety Information (RSI), and other relevant documents
About Braveheart Bio
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease.