[Remote] Executive Director, Pharmacovigilance

Note: The job is a remote job and is open to candidates in USA. Tenpoint Therapeutics is a global biotechnology company focused on developing innovative treatments for vision issues in the aging eye. They are seeking an Executive Director of Pharmacovigilance to establish and lead all 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 point of accountability for all pharmacovigilance activities across Tenpoint’s pipeline and commercial portfolio. • Third-party management: Oversee and manage third party PV vendor as Tenpoint’s contract PV partner, ensuring quality, 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 Commercial functions to integrate PV insights and support safe product development and commercialization. • Safety leadership: Provide 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 track record of managing PV through a contract organization, including oversight 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 clearly to technical and executive audiences. Benefits • Generous medical, dental, and vision health insurance plans • Flexible spending accounts for health and dependent care • Short-term, long-term, and life/AD&D insurance • Employee Assistance Program • 20 paid vacation days, 12 paid holidays, and 12 sick days • 401(k) Retirement Plan with 100% company match up to 4% and immediate vesting • Hybrid work options • Wellness Resources • Stock Options Company Overview • Tenpoint Therapeutics Ltd. 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/. Apply tot his job Apply To this Job