Sr. Director, Pharmacovigilance Operations

Overview

Be Seen and Heard at EyePoint

 

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:

• focus on science and innovation, we aim to offer a lifetime of clearer vision
• commitment to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases
• Delivery of innovative therapeutics to protect vision, specializing in sustained-release treatments for serious retinal diseases.

 

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.  

 

The Sr. Director, PV Operations will provide oversight for the Pharmacovigilance (PV) Operations elements of the pharmacovigilance function. This includes overall accountability for vendor management/oversight; training; business integration; Quality Management System (QMS); Safety Data Exchange Agreements (SDEAs); PV Safety database; and Budgets. He/she will also lead, and actively contribute to, the development or revision of existing PV processes, which may not be limited to: Quality, standards, and training. The incumbent works cross-functionally with internal departments/key stakeholders and external resources on pharmacovigilance-related matters.

 

This position reports to the VP, Pharmacovigilance. This role is remote.

Responsibilities

Primary responsibilities include, but are not limited to, the following:

 

Individual 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.

Qualifications

Primary skills and knowledge required include, but are not limited to the following:

• 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 bu