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Director, Drug Safety & Pharmacovigilance Scientist

Remote:

Full Remote

Contract:

Full time

Experience:

Expert & Leadership (>10 years)

Work from:

Massachusetts (USA), United States

Offer summary

Qualifications:

Advanced degree in life sciences (MD, PharmD, PhD), Minimum 10 years in pharmacovigilance, 2 in leadership, In-depth understanding of global pharmacovigilance regulations, Strong analytical and problem-solving skills, Exceptional written and verbal communication skills.

Key responsabilities:

Identify and evaluate safety signals through data analysis.
Prepare and submit safety reports to regulatory authorities.
Collaborate with cross-functional teams on safety issues.
Maintain thorough documentation of safety data.
Provide training on pharmacovigilance processes.

Dyne Therapeutics Biotech: Biology + Technology Scaleup https://www.dyne-tx.com/

51 - 200 Employees

See more Dyne Therapeutics offers

Job description

Company Overview:

Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD). 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 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.