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Role Description

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
• Budgets

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

• 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’s pharmacovigilance function.
• Responsible for PV budgets, MSA and SOW with PV vendors.
• May manage, coach and mentor direct reports.

Qualifications

• Expert knowledge of relevant FDA, EU, and 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.
• 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.

Requirements

• Bachelor’s degree in healthcare including BSN/RN, RPh, PharmD degree.
• 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.

Benefits

• Robust total rewards in a science-based entrepreneurial culture.
• Empowerment of curiosity and innovation.
• Space for every voice and perspective to be heard.