EyePoint · 7 hours ago
Director, Pharmacovigilance Sciences
United States
Full-time
Remote
Director/Executive
$198K/yr - $250K/yr
8+ years expEyePoint is an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics. The Director, Pharmacovigilance Sciences will oversee pharmacovigilance activities and collaborate with key stakeholders to ensure compliance and safety in the management of investigational and marketed products.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Ensure oversight and assume overall responsibility/accountability for assigned product or therapeutic area pharmacovigilance activities
Overall project management responsibility for compiling pharmacovigilance aggregate reports (e.g., DSUR, PBRER, topic reports) and ensure effective planning such that stakeholder input is requested/received for applicable sections of the report meeting regulatory timelines
Contribute to relevant sections collaborating with safety physician
Provide guidance to other functions to contribute relevant section and address questions
Overall project management responsibility for compiling safety information for Clinical Overviews, responses to regulatory questions, post-marketing safety assessment, Risk Management Plans, labeling justifications, CCSI development, IB update, label update as well as written summaries of clinical safety of common technical document
Assume lead role in review and approval process for all pharmacovigilance reports working in conjunction with safety physician and external pharmacovigilance vendor
Collaborate with the safety physician to ensure all information is available to allow for informed medical review and benefit-risk assessment of assigned product/s
Conduct safety surveillance and signal detection activities for assigned product or therapeutic area
Responsible for ensuring efficient plan for routine and ad-hoc Safety Review Team (SRT) meetings and that stakeholder provide input from their respective areas of responsibility
Conduct cross-functional SRT working with safety physician on periodic and ad-hoc basis
Ensure that regulatory and RMP commitments are efficiently tracked and presented as part of the SRT process
Liaise with SRT chair to facilitate communication and support for decisions resulting from the SRT (e.g., update of RMPs, labeling, regulatory notifications)
Effectively collaborate with stakeholders outside of PV
Represent PV department in cross-functional clinical programs and registration activities and provide support to clinical developmental programs
Collaborate with medical monitor(s), safety physician and Regulatory Affairs to process, review, submit, track and monitor expedited safety reports to appropriate domestic and international regulatory authorities
Provide support to Drug Safety Monitoring Board
Provide oversight and contribute to draft, review and track of safety data exchange agreements and pharmacovigilance agreements with Alliance partners
Provide guidance, training, and oversight to pharmacovigilance vendor supporting pharmacovigilance activities for investigational and marketed products
Maintain a thorough understanding of clinical protocol(s) and the scope of work for assigned projects
Develop, implement and support policies, standard operating procedures (SOPs), tools, etc., pertaining to pharmacovigilance activities
Support PV audits and inspections
Participate in audit preparedness activities and serve as subject matter expert during regulatory inspections in collaboration with team members
Qualification
Required
Strong knowledge and track record in pharmacovigilance sciences including signal detection, safety reviews, literature searches, aggregate safety reports, and clinical documents such as IB, protocol, & ICF. Experience with pharmacovigilance of both investigational and marketed drugs
Experience and knowledge of safety databases; strong knowledge of medical terminology and understanding of MedDRA search strategy
Advanced knowledge of FDA regulations, ICH guidelines relating to pharmacovigilance, and Ex-US PV regulations experience
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 or Master's degree in science related area including BSN/RN, Pharmacy, PharmD degree
Minimum of 8 years progressively responsible pharmacovigilance experience in a pharmaceutical, biotechnology or related environment, at least 3 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
Preferred
Experience in ophthalmic products is highly desirable
Experience in signal detection, safety surveillance, risk mitigation and risk management a plus
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