Safety Science Director

3 weeks ago


Redwood City, California, United States Biomea Fusion, Inc. Full time
Job Summary

The Associate Director, Safety Science is a critical role at Biomea Fusion, Inc. responsible for ensuring the safety profile of our study drug and the well-being of patients using our products. This position requires a strong background in pharmacovigilance and a proven ability to develop and implement safety strategies to identify, evaluate, and mitigate risks associated with our products.

Key Responsibilities

• Develop and implement safety strategies to ensure the safety profile of our study drug
• Collaborate with Product Safety Physicians to provide safety expertise for assigned developmental products
• Lead signal evaluation and safety monitoring activities, contributing to pharmacovigilance activities, including benefit/risk and regulatory activities and interactions
• Review and write safety sections for development of Protocols, IBs, ICFs, SAPs/TFLs, Aggregate Safety Reports, Risk Management Plans, Medical Monitoring Plans, and CSRs
• Collaborate with Data Analytics, Biostats, and Data Management to ensure that outputs of safety data from both safety and clinical trial databases are standardized and of high quality to meet the need for preparation of aggregate safety reports and other required aggregate safety analyses
• Assist in authoring and maintenance of the Safety Surveillance Plans
• Provide analysis and insight for integrated Benefit/Risk assessments
• Actively contribute to product safety surveillance, coordinating aspects of signal evaluation/safety review activities to identify potential risks or emergent safety issues
• Assist in leading and improving the oversight and monitoring of effectiveness of the risk minimization measures
• Maintain and enhance knowledge of safety profiles for allocated products, including both Biomea and competitor products
• Lead the evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates for regulatory inspections

Requirements

• PharmD, RN, MD, or PhD in a medical field or biological science
• 8+ years industry experience in pharmacovigilance in an analytical role
• Prior experience as a safety scientist, a plus
• Pharmaceutical product development experience required
• Proven ability to work as a collaborative member of the management team
• Intermediate knowledge working with a safety database for retrieval of safety information; Familiarity with data mining tools and exploratory analyses tools such as Tableau
• Highly proficient using Microsoft Office Suites

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