Sr. Director, Pharmacovigilance​/Product Safety; MD

Sr. Director, Pharmacovigilance / Product Safety (MD)

Boston, MA, USA

HYBRID

EXEMPT

REPORTING TO THE CHIEF DEVELOPMENT OFFICER

Pretzel Therapeutics is a biotechnology company headquartered in Boston, Massachusetts, with research facilities in Mölndal at GoCo House, part of GoCo Health Innovation City. Pretzel Therapeutics is dedicated to developing life-changing medicines with a broad pipeline of first-in-class treatments addressing novel targets within the mitochondria. By harnessing cellular energetics to modulate disease processes and improve survival, function and quality of life, we are ushering in a new treatment paradigm for a breadth of conditions spanning neurological, muscle, metabolic and rare diseases.

The Sr. Director, Pharmacovigilance / Product Safety (MD) will provide strategic and medical leadership for pharmacovigilance and product safety across Pretzel Therapeutics’ clinical development portfolio. This individual will be responsible for establishing and executing safety strategies, providing medical oversight of safety surveillance, and ensuring the appropriate identification, assessment, management, and communication of safety risks throughout clinical development.

The Sr. Director will serve as Pretzel’s senior medical safety expert and partner closely with Clinical Development, Clinical Operations, Regulatory Affairs, and other cross-functional stakeholders to ensure patient safety, rigorous benefit-risk assessment, and compliance with applicable global pharmacovigilance requirements. This role will provide safety leadership to development teams and governance forums and ensure appropriate pharmacovigilance capabilities, processes, and external partnerships are in place as Pretzel’s programs advance through development.

• Provide strategic and medical leadership for pharmacovigilance and product safety activities across Pretzel’s clinical development portfolio
• Develop and execute program-level safety surveillance strategies and ensure appropriate safety monitoring and risk management throughout clinical development
• Lead medical assessment and oversight of serious and clinically significant safety events, emerging safety trends, potential signals, and other safety information requiring medical judgment
• Lead signal detection, evaluation, management, and communication activities and provide recommendations regarding potential impact on clinical development programs
• Provide medical and strategic oversight of aggregate safety reports, including DSURs and other required periodic safety assessments, and lead ongoing benefit-risk evaluation for assigned products
• Provide senior safety leadership to Clinical Development and cross-functional program teams, including input into protocols, investigator brochures, informed consent forms, safety monitoring plans, regulatory submissions, and development strategies
• Establish and oversee pharmacovigilance governance, processes, procedures, and infrastructure appropriate for Pretzel’s portfolio and stage of development
• Provide sponsor oversight of external pharmacovigilance vendors and partners, including performance, quality, compliance, and delivery of safety activities
• Represent Product Safety in cross-functional development and governance forums and communicate significant safety findings, emerging risks, and benefit-risk recommendations to senior leadership
• Partner with Regulatory Affairs on health authority interactions, regulatory submissions, safety-related responses, and global reporting requirements
• Ensure pharmacovigilance activities comply with applicable FDA and international regulations, ICH guidelines, company procedures, and established quality standards
• Provide leadership for…