Director, Pharmacovigilance & Safety

Director, Pharmacovigilance & Safety

Cambridge, Massachusetts, United States

Description

Our Culture: Why work with us?

At Foghorn Therapeutics, we believe in “People First, Mission Always.”

We put “People First” because we know our people are the key to everything we will accomplish. We value the diversity of background, ideas, perspectives and experiences that our team members bring to Foghorn Therapeutics – demonstrated by our community speaking more than 22 languages and representing over 24 nationalities. We value our teammates as people, not just as employees – validated by our actions that let our people know that we care about them, their families, and their lives.

We say “Mission Always” because we know a relentless commitment to our mission will make a difference in the lives of others. We believe our success will come from evaluating the data to follow the science. We work hard to develop a new class of therapies that could improve the lives of over 2.5 million people with cancer.

Our culture is focused on succeeding through the evaluation of data, not people. And in that, relationships can flourish and develop.

Our Science:

The groundbreaking science behind our therapies continues to yield vital insights into diseases that have confounded physicians and researchers. Our core scientific approach is centered on the chromatin regulatory system, which opens and closes the right sections of DNA at the right time. Breakdowns in the chromatin regulatory system leads to a wide range of diseases, including cancer, impacting millions of people.

Our proprietary Gene Traffic Control® platform is a powerful tool for understanding and modulating the chromatin regulatory system. We are pursuing multiple treatments for breakdowns in this system. We are the only company with the ability to study and target the chromatin regulatory system at scale, in context, and in an integrated way.

The Role:

This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Director, Pharmacovigilance & Safety will manage overall performance of the PV protocols and compliance with global regulatory requirements. This position reports to the Senior Director of Pharmacovigilance & Safety.

In This Role, You’ll Get To:

• Manage overall performance of the PV protocols and compliance with global regulatory requirements by implementation of appropriate SOPs, processes, metrics; monitor of performance and training at a global level; establish and maintain policies and procedures for the PV function
• Monitor CRO/vendor(s) PV activities including Safety Management Plans, safety event processing and reporting, and aggregate report preparation
• Oversee medical review of safety events to ensure accuracy, integrity and completeness of safety information, and consistency of medical coding of safety data
• Identify and evaluate safety signals through the assessment of single case safety reports and aggregate trend analyses; provide input and review of responses to regulatory agency questions regarding patient safety
• Ensure the ongoing evaluation of the overall safety profile for investigational products, serving as the product safety expert to bring potential safety issues to the attention of the clinical team and leadership; supports development and maintenance of product benefit-risk profile
• Contribute to safety sections of clinical documents, including the review and approval of the safety portion of protocols, final study reports, IB, and other documents, as needed; drives annual DSUR preparation; oversees the activities of internal safety meetings/committees

Requirements

About you:

• MD, DO, RN, Pharm D, PhD or RPh and minimum 8+ years Safety/Pharmacovigilance experience in Biotech, Pharma or Clinical Research Organization
• Working knowledge of relevant FDA, EU, ICH guidelines and regulations
• Experience working with CRO/vendors, and relationship management preferred
• Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
• Familiarity with common safety databases (e.g., ArisG, Argus) preferred
• Working knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding

Benefits

Foghorn Therapeutics is pleased to provide you and your family with a comprehensive suite of benefits, including:

• Highly