[Hiring] Sr. Director, Pharmacovigilance Operations @EyePoint Pharmaceuticals, Inc.
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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 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 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.
Apply tot his job
Apply To this Job
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 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 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.
Apply tot his job
Apply To this Job