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Vice President, Pharmacovigilance
1 week ago
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 be 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 preferredIn-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:
C ompetitive 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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