EyePoint · 16 hours ago
Sr. Director, Pharmacovigilance Operations
United States
Full-time
Remote
Director/Executive
$236K/yr - $300K/yr
15+ years expEyePoint is an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics. The Sr. Director, PV Operations will provide oversight for the Pharmacovigilance Operations, ensuring compliance and quality management while leading process improvements and vendor management.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Provide oversight for work performed by pharmacovigilance vendor(s) including compliance, KPI, etc
Participate in process improvements and vendor-client Safety Management Plans and timelines for processing and reporting safety data from clinical trials and post marketing surveillance
Accountable for business integration including safety data migration and integrating new assets or companies into EyePoint PV system
Accountable for development or revision of SOPs, work instructions, guidance in regard to all functions within PV
Participate in investigator meetings as needed to train investigators and qualified site personnel in the collection and reporting of SAEs to study sponsor; receive clinical study SAE reports, review for medical/regulatory content and assure accuracy per protocol requirements; interface with medical monitors for medical assessment and regulatory classification of SAEs; manage and facilitate SAE reconciliation across projects to ensure compliance with objectives and goals, adverse event follow-up and case closure
Accountable for Quality Management System within PV including compliance, best practices, and continuous process improvements
Accountable for working with relevant internal departments, and actively contributing to the development of the PSMF
Work closely and collaborate with EU and local Qualified Person (QP) to develop new or maintain pharmacovigilance processes supporting both development and marketed/commercial products
Develop SDEAs or pharmacovigilance agreement with EyePoint partners and vendors for specific obligations for safety data exchange and reporting
Build relationships and collaborate with all cross functional stakeholders (especially QA, MA, Commercial, IT) within the company to develop or improve process for safety reporting and reconciliation of safety data
Contribute to inspection readiness and lead HA inspections of EyePoint’ pharmacovigilance function
Responsible for PV budgets, MSA and SOW with PV vendors
May manage, coach and mentor direct reports
Qualification
Required
Expert knowledge of relevant Food and Drug Administration (FDA), European Union (EU) and International Conference on Harmonisation (ICH) guidelines, initiatives, and regulations governing pharmacovigilance
Experience with both Investigational and marketed products including world-wide postmarketing surveillance
Experience leading and contributing to process improvements, quality management system, inspection readiness, Health Authority audits, standardization of safety reports, SDEA negotiations, vendor management and oversight, etc
Experience building Postmarketing Surveillance Plan and processes for newly marketed products
Experience and knowledge of safety databases; strong knowledge of medical terminology and understanding of MedDRA search strategy
Excellent oral and written communication skills
Ability to build cross functional relationships
Proficiency with Word, PowerPoint. Basic Excel Skills
Up to 10% travel may be required
Bachelor's degree in healthcare including BSN/RN, RPh, PharmD degree
Experience in ophthalmic products is highly desirable
Minimum of 15 years of seasoned and progressive pharmacovigilance experience in a pharmaceutical, biotechnology or related environment, at least 5 of which were spent in a leadership role within pharmacovigilance
Demonstrated hands-on experience identifying, developing and implementing improvements to departmental processes that increase efficiency and maintain or improve quality
Ability to work independently and collaboratively, as required, in a fast-paced matrixed team environment consisting of internal and external team members
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
Company
EyePoint
EyePoint (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to improve the lives of people with serious retinal diseases.
51-200 employees
H1B Sponsorship
EyePoint has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (4)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$803.8MKey Investors
Silicon Valley BankOcumension TherapeuticsEssex Woodlands Healthcare Partners
2025-10-14Post Ipo Equity· $150M
2023-12-05Post Ipo Equity· $215.9M
2022-03-09Post Ipo Debt· $45M
Leadership Team
Paul Ashton
President, Chief Executive Officer and a Director
D
Diane Shay
Vice President of Quality
Recent News
Longevity.Technology
2026-01-16
Clinical Trials Arena
2026-01-11
2025-12-17
Company data provided by crunchbase