Pharmacovigilance Manager

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:

• preventing blindness through vision-saving medications
• delivering best-in-class proprietary pharmaceutical technologies
• transforming ocular drug delivery

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:

• Thorough knowledge of the clinical drug development process and experience in all aspects of global drug safety reporting from Clinical trials to Post Marketing
• Experience with the current drug safety database systems, especially Argus, experience with EDC platforms and with coding dictionaries, WHO-DD and MedDRA
• Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex information and safety data
• Experience in the preparation and authoring of aggregate safety reports
• Knowledge of Pharmacovigilance regulations and guidelines including Good Pharmacovigilance Practices (GVP), Good Clinical Practices (GCP) and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
• Ability to work effectively in a collaborative small team environment
• Must have excellent analytical and problem-solving ability
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
• Excellent communication skills and ability to influence across multiple functions

Level of Education Required:

• Advanced Degree in Life Sciences, Pharmacy, Nursing, or medicine with pharmaceutical industry background and proven competence in Pharmacovigilance

Number of Years of Experience in the Function and in the Industry:

• Minimum 5-7 years relevant Global Pharmacovigilance and Drug Safety experience working for a pharmaceutical company or CRO

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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