About the Role
This role leads the development and execution of global pharmacovigilance strategies across clinical and post-marketing phases, supporting the safe use of investigational and approved therapies. The individual will manage safety databases, oversee case processing, and contribute to regulatory submissions and risk management plans.
Responsibilities
- Lead the design and implementation of global pharmacovigilance strategies for drug development programs
- Oversee the safety database and ensure accurate, timely processing of adverse event reports
- Manage the preparation and submission of periodic safety update reports and other regulatory documents
- Serve as safety representative in cross-functional development teams and program meetings
- Conduct signal detection activities and lead evaluation of emerging safety data
- Develop and maintain risk management plans and pharmacovigilance system master files
- Ensure compliance with international regulations and guidelines including FDA, EMA, and ICH
- Collaborate with clinical operations to implement safety monitoring protocols
- Provide safety training to internal teams and external partners
- Lead vendor oversight for safety database management and case processing
- Support safety aspects of clinical trial applications and marketing authorization submissions
- Evaluate aggregate safety data to inform medical decision-making and labeling updates
- Participate in safety review committees and data monitoring boards
- Contribute to the development of safety sections in clinical study reports and protocols
- Monitor global safety literature and regulatory intelligence for relevant updates
- Coordinate responses to regulatory agency inquiries on safety matters
- Ensure proper documentation and archival of safety records
- Support post-authorization safety studies when required
- Work with legal and compliance to address product liability and safety reporting obligations
- Maintain up-to-date knowledge of pharmacovigilance standards and evolving regulations
Compensation
Competitive salary and equity package commensurate with experience
Work Arrangement
Hybrid work model with presence required in the Cambridge, MA office several days per week
Team
Part of the Clinical Development organization, reporting to the Head of Safety, collaborating with regulatory, clinical, and medical affairs teams
Why Join Us
- Opportunity to shape the safety strategy for a pipeline of novel oncology and targeted therapies
- Work in a science-driven, collaborative environment focused on transformative medicines
- Direct impact on patient safety and regulatory success across global markets
- Culture that values innovation, accountability, and scientific rigor
Education & Experience
- Advanced degree in a scientific or medical discipline required
- Minimum of 8 years in pharmaceutical safety or pharmacovigilance roles
- Leadership experience in managing safety operations for clinical-stage assets
Available for qualified candidates requiring sponsorship
