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 seen with other approaches. Dyne has a broad portfolio of programs for serious muscle diseases, including candidates for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit, and follow us on TwitterLinkedIn and Facebook.

Role Summary

The Director, Pharmacovigilance (PV) Operations at Dyne is responsible for tactical and strategic aspects of PV operations activities involving Dyne programs. This individual is accountable for ensuring compliance with and continuous improvement of Dyne PV process related to safety governance, management of individual case safety reports, aggregate reporting, signal detection, implementation of safety language in clinical trial and regulatory documents, and corporate training on safety SOPs and Policies. Oversight of the Pharmacovigilance Service Provider (PSP) is a key aspect of this role. This role partners closely with the Head of PV in the implementation of signal detection plans and be an integral member of study teams across Dyne programs. Ultimately, this position is accountable for resourcing, development, training, and management of a high-performing PV operations team.


Primary Responsibilities

  • Provide strategic planning, implementation, and management of Dyne Pharmacovigilance Operations activities
  • Provide expert guidance and leadership both internally and externally based on in-depth knowledge of development and post-marketing safety requirements, per ICH; US and international regulations and guidelines; and EU Good Pharmacovigilance Practice (GVP)
  • Responsible for managing external PV vendors, and internal staff (when added) related to PV operational activities, creating a highly efficient team across insourced and outsourced resources commensurate to the needs of Dyne clinical programs
  • Oversee the set-up of new safety projects, including development of study-specific Safety Management Plans and set up of safety systems and configurations in the PV database to accommodate these trials and products, including specific workflows and reporting/querying functionalities
  • Build and implement pharmacovigilance systems fully compliant with the applicable worldwide Health Authority PV regulations
  • Responsible for successful oversight of systems and MedDRA updates in collaboration with the relevant vendor(s)
  • Responsible for compliant and quality execution of all operational activities related to safety case management and related PV activities, and participation in safety case review
  • Oversee and ensure timely submissions of expedited reports to the FDA & other health authorities and to EC/IRBs via external vendors
  • Effectively collaborate with key stakeholders at all levels in the organization and represents PV Operations on program teams and applicable governance committees
  • Support, with Dyne Data Management, reconciliation activities performed by the PSP between the safety DB and the clinical database
  • Assist in the preparation and management of aggregate safety reports (e.g., IND safety reports, DSURs, PSLLs etc.)
  • Assist with the development, implementation, maintenance, and continuous improvement of pharmacovigilance related SOPs, policies, and work instructions
  • Create and track PV Operations-related metrics, e.g., case processing, for internal monitoring of performance of the PV function
  • Participate in the development and implementation of an inspection readiness program with the contribution of other PV and non- PV stakeholders including the quality function
  • Participate in regulatory inspections/audits as they relate to PV activities
  • Work with QA department to maintain a state of high PV inspection readiness across all regions/countries
  • Work with QA to ensure root cause analysis of any deviations from PV process, and the implementation of effective corrective and preventative action plans for any PV-related quality issues

Education and Skill Requirements

  • Minimum of 10 years of experience in the pharmaceutical industry or CRO, with in Pharmacovigilance Operations in the biopharmaceutical industry, with at least 5 years of leadership and managerial experience in overseeing global/regional PV operations
  • Bachelor’s degree in life sciences, pharmacy (RPH or PharmD), nursing (RN, BSN, MSN or NP), PA or equivalent health experience, advanced Life Sciences Degree or MBA preferred
  • Experience in the management of safety information originating from clinical trials and post-marketing sources, including end-to-end management of individual case safety reports
  • Experience leading and building PV Operations teams is preferred
  • Thorough knowledge of relevant FDA and International Conference on Harmonization (ICH) guidelines required, including Good Clinical Practices (GCP) guidelines
  • Thorough knowledge of pharmacovigilance regulations in US (CFR) and Europe (GVP)
  • Detailed knowledge of drug safety databases, particularly Aris-G or ARGUS
  • Experience working with MedDRA for drug coding
  • Significant experience working with PV vendors including oversight and management experience
  • Must have excellent interpersonal skills, ability to develop important relationships with key stakeholders at all levels of management, good conflict management and negotiation skills, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs, and recommendations
  • Strong verbal and written communications and presentation skills
  • Proven problem solving and decision-making skills
  • Possess strong leadership skills and the ability to compile and disseminate information to others in a cohesive fashion to assure a clear understanding of project status and direction.
  • Proven ability to work on multiple projects in a fast-paced environment.



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.

Apply for this Job

* Required

resume chosen  
(File types: pdf, doc, docx, txt, rtf)
cover_letter chosen  
(File types: pdf, doc, docx, txt, rtf)
When autocomplete results are available use up and down arrows to review
+ Add another education

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Dyne Therapeutics’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.