Eyepoint Pharmaceuticals Watertown , MA 02472
Posted 3 weeks ago
Overview
Be Seen and Heard at EyePoint Pharmaceuticals
At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we're taking in business fuels our success for:
We See You.
Your wellbeing
Your professional worth
Your future at EyePoint
EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There's space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected.
An exciting opportunity is available for a Pharmacovigilance Manager at EyePoint Pharmaceuticals. We are seeking a self-motivated and talented person who will be responsible for Pharmacovigilance (PV) activities involving the company's investigational products and clinical trials. This position will report to the Director, (PV).
This position is located in Watertown, MA. We offer a hybrid work schedule. Remote candidates will be considered.
Responsibilities
Primary responsibilities include, but are not limited to, the following:
Individual responsibilities
Provide functional expertise in management of individual case safety reports, safety review of ICSR narratives and relevant queries
Assist in accurate preparation of Aggregate Safety Reports (e.g DSURs, PADERs, PBRERS) and review of these documents as needed
Provide support for safety sections of clinical documents including Protocols, ICFs, IBs and other relevant documents as needed
Responsible for creating and tracking AE metrics for internal safety reports, review of monthly AE line listings, reconciliation reports, License Partner Reports etc
Assist with management and oversight of the DSPV vendors on a day-to-day basis, ensure that applicable management monitoring plans such as Safety Management Plans, Quality Management Plans are current and in compliance with regulatory requirements.
Participate in meetings with Safety vendors, internal study teams and interdepartmental meetings as required.
Collaborate cross functionally with other team members including but not limited to Clinical Operations, Clinical Development and Regulatory with respect to safety related issues
Responsible for the oversight, management and communication of global business partner safety data exchange agreements and other contracts, to ensure compliance with data exchange
Ensure inspection readiness by maintaining compliance with applicable SOPs, regulations and guidelines
Provide support and participate in inspections and audits related to PV activities as required.
Maintain up to date knowledge of basic Safety regulations and company's SOPs
Qualifications
Primary skills and knowledge required include, but are not limited to the following:
Level of Education Required:
Number of Years of Experience in the Function and in the Industry:
Envision Your Future
With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.
The collective power of our values influences everything we do, and everything we do for you.
Success begins with our People
Patients First
Integrity
Results-Driven
Innovation
Team Focus
Diversity & Inclusion
EyePoint Pharmaceuticals is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.
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#LI-Remote
Eyepoint Pharmaceuticals