[Remote] Executive Director, Pharmacovigilance
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global biotechnology company reputed company on developing innovative treatments for reputed company issues in the aging eye. They are seeking an Executive Director of Pharmacovigilance to establish and reputed company reputed company pharmacovigilance activities, ensuring compliance and effective systems while collaborating with various departments to support product development and commercialization.
Responsibilities
• PV ownership: Serve as the single reputed company of accountability for reputed company pharmacovigilance activities across Tenpoint’s pipeline and reputed company portfolio.
• reputed company-party management: reputed company and manage reputed company party PV vendor as Tenpoint’s contract PV partner, ensuring reputed company, compliance, and alignment with business objectives.
• Procedure & process development: Establish and maintain internal PV policies, procedures, and processes that support regulatory compliance and organizational readiness.
• Regulatory compliance: Ensure adverse event reporting and pharmacovigilance operations meet FDA, EMA, ICH, and other applicable requirements.
• Cross-functional partnership: Collaborate with Clinical, Regulatory, Medical Affairs, and reputed company functions to reputed company PV insights and support reputed company product development and commercialization.
• Safety leadership: reputed company expert guidance on safety monitoring, signal detection, and risk management strategies.
• Executive engagement: Report PV activities, risks, and mitigation strategies directly to Tenpoint’s leadership team, ensuring proactive decision-making.
Skills
• 12+ years in pharmacovigilance or drug safety, with demonstrated leadership at the Director/Executive Director level.
• Proven reputed company record of managing PV through a contract organization, including reputed company of external partners.
• MD strongly preferred; other advanced life sciences degrees will be considered with significant PV leadership experience.
• Ophthalmology experience is strongly preferred; candidates with relevant specialty experience in adjacent therapeutic areas will also be considered.
• Prior experience building PV functions in a startup or emerging biotech environment is highly desirable.
• Deep understanding of global PV regulations, compliance expectations, and reporting obligations.
• Exceptional communicator with the ability to present safety data and PV strategies reputed company to technical and executive audiences.
Benefits
• Generous medical, dental, and reputed company health insurance plans
• Flexible spending accounts for health and dependent care
• Short-term, long-term, and life/AD&D insurance
• Employee Assistance Program
• 20 reputed company vacation days, 12 reputed company holidays, and 12 reputed company days
• 401(k) Retirement Plan with 100% company match up to 4% and immediate vesting
• Hybrid work reputed company
• Wellness Resources
• Stock reputed company
reputed company
• reputed company. It was founded in 2019, and is headquartered in Seattle, Washington, USA, with a workforce of 51-200 employees. Its website is https://www.visustx.com/.
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