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. For more information, please visit https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
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.
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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.
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Dyne Therapeutics Waltham, Massachusetts, USA Office
1560 Trapelo Rd, Waltham, MA, United States, 02451
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