Associate Director, Head of Safety Operations, Safety Systems and Data Management

Associate Director, Head of Safety Operations, Safety Systems and Data Management

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.Responsibilities

Design, develop, implement and provide leadership for a GPS Safety Operations and Safety Systems and Data Management team with the appropriate structure and talent to support the global pharmacovigilance system and meet expectations.Management of all Safety Operations including Literature, Quality Control, Clinical case processing and regulatory compliance of North America according to PV regulations.Manage global vendors in charge of the Global Safety Database including contract review, negotiation and vendor oversight.Responsible for Data Management, defining data entry conventions and adequate custom report formats and database solutions to support consistent and accurate pharmacovigilance data collection, data analysis, report generation, and submission tracking; Responsible for ICSR submissions worldwide.Lead and manage PV inspections by FDA and Health Canada and internal audits in North America.Represent GPS as Subject Matter Expert in Safety Operations and PV Safety Systems, both internally in audits and externally in regulatory inspections.Own the Global Safety Operations and Safety Systems Business Continuity Plan (BCP) and manage a process to ensure a BCP is in place and tested periodically.Safety Operations

Responsible for management of daily operations, including adverse event case processing, global literature search and submission of ICSR to Health Authorities worldwide in compliance with regulations.Ensure adequate processes and resources are in place to manage requests for data reports from the Safety Database and related tools.Determine root causes of nonconformance and assist in developing effective problem solution strategies to ensure compliance with safety information reporting to HAs worldwide.Work with the IT PV service provider to convert the GPS business needs into user requirements and deliverables that will assist in defining and validating the configuration of the end solution; Ownership of GPS Business Continuity Plan (BCP) and SOP.PV North America region

North America compliance of PV system and operations according with applicable regulations and GPS procedures.Responsible and accountable for directing all North American (US FDA, Health Canada) PV inspections and PV audits and provide all aspects of support.Responsible for responding to PV audits/inspections in North America, working within Vantive’s Quality Management System (QMS), to open corrective actions/preventive actions (CAPAs) for Global Patient Safety audit/inspection finding and, where applicable, creating gap and risk mitigation plans to address any identified issues.PV Safety Systems and Data Management

Ensure adequate processes and resources are in place to manage requests for data reports from the Pharmacovigilance Database and related tools.Facilitates planning sessions to build consensus among GPS and applicable regulatory team members, regarding their requirements, priorities, etc. as they relate to the Pharmacovigilance Database and related tools.Determines desired functionality and/or enhancement of the Pharmacovigilance Database and related tools to support GPS processes, procedures, metric reports, and/or specific project(s) based on departmental needs, regulatory agency requests, business needs, outside partner requests, etc.Works with any IT service provider to convert the GPS business needs into user requirements and deliverables that will assist in defining and validating the configuration of the end solutionWhat You’ll Bring

Bachelor of Science, or more advanced degree in relevant scientific disciplineSignificant experience in Safety Operations having successfully directly managed teams, including coaching, mentoring, and providing feedback.Expert knowledge of Pharmacovigilance Safety Systems (ARGUS, and other safety database applications) and electronic data capture systems.Broad understanding of the global regulatory environment.Leadership experience in managing direct and shared resources, some at a geographic distance.Knowledge of case processing regulations and guidelines worldwideProficiency with PV vendor management.Experience working with the FDA and other regulatory agencies is preferred.Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form LinkRecruitment Fraud Notice

Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.Seniorities and Job Details

Seniority level: DirectorEmployment type: Full-timeJob function: Management and ManufacturingIndustries: Medical Equipment ..... full job details .....