Vice President, Pharmacovigilance

1 month ago

Waltham, United States Viridian Therapeutics Inc. Full time

Description

At Viridian Therapeutics, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team's expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets.

Reporting to the Chief Medical Officer, the Vice President, Pharmacovigilance will be responsible for providing medical oversight for the global drug safety and pharmacovigilance function to ensure proactive and timely benefit-risk assessments of all safety data, related to our portfolio of autoimmune disease and drug-device combination therapies. The VP, Pharmacovigilance will provide strategic and tactical leadership and oversee all aspects of Pharmacovigilance activities through all stages of clinical development (Phase I-IV) as well as post-marketing patient safety.

This role may be remote or may based in our Waltham, MA headquarters. Our office-based employees follow a hybrid in-office schedule. Remote work is allowed, and the frequency is at the discretion of management.

Responsibilities (including, but not limited to):

* Lead global clinical safety, pharmacovigilance and risk management activities throughout the product lifecycle for investigational and marketed products across the pipeline
* Build and manage a high-growth pharmacovigilance team by setting clear expectations & providing hands-on leadership, promoting collaboration and team cohesiveness
* Provide strategic oversight for safety sections of all regulatory documents, including BLA/MAA/NDA, EU Risk Management Plans/REMS, PSUR/PBRERs, DSURs, ICFs, public presentations and key scientific articles and abstracts
* Review trends in safety, including in class of therapeutic, and provide insights as to any developments
* Advise Executive Leadership Team on safety matters and provide strategies for addressing and informing on safety matters, including information provided to investors, patients, and physicians
* Ensure compliance with global pharmacovigilance regulations and guidelines
* Provide medical guidance and evaluation of all pre- and post-marketing safety data:
* Develop the Drug Safety & Pharmacovigilance budget and long-term forecast, creating timeline management systems and processes to ensure achievement of key deliverables Lead the process for acquisition and retention of safety vendors
* Lead the development of accurate benefit/risk assessments and oversee development of patient-centric risk mitigation strategies
* Establish framework and provide leadership for internal safety governance
* Oversee the design and implementation of medical safety management systems, including responsibility for the internal Safety Review Board, provide leadership and oversee adverse event signal detection activities, including evaluation, validation, and escalation
* Oversee relationships with pharmacovigilance service providers and vendors, ensuring quality and efficiency in outsourced activities
* Collaborate cross-functionally and with key internal and external stakeholders, including clinical operations, clinical development, regulatory affairs, quality assurance, and medical affairs, senior management, regulatory agencies, alliance partners, investigators and KOLs

Requirements

* Requires a Medical Degree; U.S. licensure and Board Certification in a relevant therapeutic area are strongly preferred
* A minimum of 15+ years' experience in pharmacovigilance leadership roles, including Head of Drug Safety/Patient Safety/ Product Safety & Pharmacovigilance for a bio-pharmaceutical/pharmaceutical company (minimum of 5 years), medical monitoring within a global CRO, and/or clinical practice in a relevant therapeutic area.
* Prior safety/pharmacovigilance experience with drug/device combination products strongly preferred
* In-depth knowledge of global pharmacovigilance regulations and guidelines, including ICH, FDA, EMA, and other relevant regulatory requirements
* Experience with evaluation, implementation and oversight of pharmacovigilance systems and processes, including developing quality and compliance metrics
* Demonstrated understanding of current global safety regulatory reporting requirements for investigational and marketed products
* Entrepreneurial, small/high-growth company biologics experience is preferred
* Public company experience, autoimmune and/or rare disease experience is a plus
* Excellent managerial and interpersonal skills to develop and maintain a cohesive and collaborative team
* Experience mentoring all levels of staff to further develop skills, provide opportunities for growth, and ensure a professionally challenging environment that fosters retention
* Demonstrated strong written and verbal communication skills
* Proven mindset of proactive continuous improvement
* Efficient independent worker with ability to focus and drive for results
* Strong attention to detail
* Ability to work in a fast paced-environment and to handle multiple tasks
* Strong commitment to ethical standards
* Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
* Ability to travel up to 20%
* The salary range for this position is commensurate with experience

Viridian offers a comprehensive benefits package including:

* Competitive pay and stock options for all employees
* Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents
* Fertility and mental health programs
* Short- and long-term disability coverage
* Life, Travel and AD&D
* 401(k) Company Match with immediate company vest
* Employee Stock Purchase plan
* Generous vacation plan and paid company holiday shutdowns
* Various mental, financial, and proactive physical health programs covered by Viridian

Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.

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