Director, Drug Safety & Pharmacovigilance Scientist
Location: Waltham
Posted on: June 23, 2025
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Job Description:
Company Overview: Dyne Therapeutics is discovering and advancing
innovative life-transforming therapeutics for people living with
genetically driven neuromuscular diseases. Leveraging the
modularity of its FORCE™ platform, Dyne is developing targeted
therapeutics that deliver to muscle and the central nervous system
(CNS). Dyne has a broad pipeline for neuromuscular diseases,
including clinical programs for myotonic dystrophy type 1 (DM1) and
Duchenne muscular dystrophy (DMD) and preclinical programs for
facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.
Role Summary: We are looking for an experienced and highly skilled
Director, Pharmacovigilance Scientist to join our dynamic team.
This person will be responsible for monitoring the safety of our
pharmaceutical products, ensuring compliance with regulatory
requirements, and contributing to the overall risk management
strategy. The ideal candidate will have extensive knowledge of
pharmacovigilance processes, strong leadership abilities, ability
to work collaboratively with multidisciplinary teams, and a
commitment to patient safety. This role is based in Waltham, MA
without the possibility of being a fully remote role. Primary
Responsibilities Include: Signal Detection and Risk Management:
Identify and evaluate safety signals through comprehensive data
analysis. Author safety signal assessment reports and aggregate
safety reports Write and maintain relevant SOPs and procedures in
compliance with global safety regulations and guidelines, and
provide training within Dyne Drug Safety and Pharmacovigilance and
cross-functionally Regulatory Compliance: Prepare and coordinate
submission of safety reports (PSURs, DSURs, CIOMS, etc.) to
regulatory authorities, ensuring compliance with all local and
international regulations Collaboration: Work closely with
cross-functional teams, including clinical operations, regulatory
affairs, and medical affairs, to address safety issues and develop
effective risk minimization strategies Documentation: Maintain
accurate and thorough documentation of safety data and related
activities in compliance with Good Pharmacovigilance Practices
(GVP) Training and Development: Provide training and support to
internal teams on pharmacovigilance processes, regulations, and
best practices. Education and Skills Requirements: Advanced degree
in life sciences (MD, PharmD, PhD, or equivalent) is required.
Minimum of 10 years of experience in pharmacovigilance, with at
least 2 year in a leadership role In-depth understanding of global
pharmacovigilance regulations and guidelines (FDA, EMA, ICH, etc.)
Strong analytical and problem-solving skills; proficiency with
safety databases and data analysis tools Exceptional written and
verbal communication abilities, with a proven track record of
effectively presenting complex information to diverse audiences
Demonstrated ability to manage multiple projects and deadlines in a
fast-paced environment Proven experience in leading teams and
fostering a collaborative work environment. LI-Onsite The
statements contained herein reflect general details as necessary to
describe the principles functions for this job, the level of
knowledge and skill typically required, and the scope of
responsibility, but should not be considered an all-inclusive
listing of work requirements. Individuals may perform other duties
as assigned, including work in other functional areas to cover
absences or relief, to equalize peak work periods or otherwise
balance workload. This description is not intended to be
constructed as an exhaustive list of duties, responsibilities, or
requirements for the position. This position may change or assume
additional duties at any time. The employee may be requested to
perform different or additional duties as assigned. All Employees
are expected to adhere to all company policies and act as a role
model for company values. Dyne Therapeutics is an equal opportunity
employer and will not discriminate against any employee or
applicant on the basis of age, color, disability, gender, national
origin, race, religion, sexual orientation, veteran status, or any
classification protected by federal, state, or local law.
Keywords: , Arlington , Director, Drug Safety & Pharmacovigilance Scientist, Science, Research & Development , Waltham, Massachusetts
