Global PV Compliance Manager

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.

Your role at Vantive

As a member of Global Patient Safety –Global Pharmacovigilance Compliance your role will encompass support and oversight of the management of different compliance areas within GPS PV including PV inspections/audits worldwide, corrective actions/preventive actions (CAPAs), Inspection readiness program, Business Continuity Plan, Quality Management System (QMS), Trainings, PV

Agreement process and other compliance activities.

What you'll be doing :

Audits and Inspections

• Participate and facilitate local/regional/global audit/inspection readiness by partnering with the GPS organization and its compliance representatives to ensure global consistency in approach.
• Trains internal/external customers on compliance and inspection readiness needs.
• Collaborate in the preparation for internal PV audits and PV Inspections conducted by Regulatory Authorities to ensure global consistency in approach.
• Supports requests for all other internal audits and regulatory inspections as it pertains to Pharmacovigilance e.g. GMP, GCP, 3rd party audits/inspections.
• Collaborate in the preparation of responses (CAPA) to internal audit and regulatory inspection findings
• Act as Subject Matter Expert and Quality Approver on the use of QWP (Trackwise 9).
• Monitors and manages commitments from internal audit and regulatory inspection findings.
• Participate in the preparation of the internal and external Pharmacovigilance audits plans for Vantive to ensure a risk-based approach.
• Collaborates with local Patient Safety on the completion of risk-based inspection assessments from Competent Authorities and with the GPS team on risk-based audit assessments from partner companies.
• Facilitate and support any GPS audit/inspection worldwide and liaise with other departments to ensure that all necessary contributors are available.

CAPA Management

• Manage and oversight the process errors (PEs) in Global Patient Safety (GPS)
• Support the GPS team as well as providers for Process Error (PE) generation
• Acts as the Process Owner for GPS Process errors
• Own the GPS NCR/CAPA and SCAR records in TrackWise
• Monitor and facilitates the status of PE/NCR/CAPA for GPS including closure in due time.
• Collaborate in RAM process to assess risk and remediation activities associated with significant quality performance issues.

Compliance

• Prepare presentation and facilitate Monthly PV Compliance Meeting and Quarterly PV Management Review (GPS QMR) meetings, if required.
• Collaborate in the development and maintain the regulatory required PV System Master File (PSMF) in compliance with GVP for medicinal products of Vantive Contribute to all compliance data for populating PMSFs Participation in LPOs - EU QPPV Quarterly Meetings, if required
• Under the direction of the lead of Global PV Compliance in the QPPV Office monitor GPS compliance, to ensure Vantive is compliant with PV regulatory requirements worldwide, the internal processes are followed, and external business partner obligations are met
• Assist in development, generation, evaluation and monitoring of internal and external compliance metrics

Third party providers

• Responsible for assessment of global PSP/MRP to ensure compliance with regulatory requirements and internal procedure.
• Perform AE awareness training to Vantive’ s business partners (Distributors).

Quality Management System

• Collaborate for maintaining compliance of all GPS Quality documents and SOPs Provide PV expertise within the Corporate Quality Management System
• Conduct effectiveness checks and internal assessments of current processes and procedures to identify potential process improvement opportunities

Business Continuity Plan

• Maintain global template for PV BCP testing
• Conduct annual PV BCP testing for affiliates and service providers

Training

• Collaborate and maintain the GPS curricula as well as the GPS training matrix
• Collaborate and maintain the Vantive Global AE awareness training
• Acts as a Learning Professional Super User
• Ensure GPS training compliance and maintain compliance.
• Generate reports related to GPS training and presents GPS training standards.

What you'll bring

• Bachelor’s degree in a biologic/medical//clinical/nursing field; advanced degree
• Significant experience in PV regulatory compliance monitoring experience in a global pharmacovigilance setting.
• Knowledge and working experience in the pharmaceutical industry, preferably in Pharmacovigilance and Drug Safety.
• Working experience with PV audits and inspections process with leadership role or as subject matters expert
• Track records in leading Regulatory Authority Inspections (i.e EMA, MHRA, FDA, Chinese HA, PMDA and TGA).
• Proven experience with CAPA writing and handling of the observations available in audit reports
• Excellent interpersonal skills that encourage teamwork
• Ability to work under strict deadlines and changing priorities and ability to multitask and prioritize changing workload for self and others
• Problem Solving- Identify priorities and key issues in complex situations, and formulate and execute issue resolution with minimal assistance
• Broad knowledge/understanding of relevant ICH guidelines, as well as FDA and EU Regulations
• Ability to interact effectively in a multifunctional and multicultural team setting
• - Experience working within a quality system to develop and optimize processes.
• Experience managing PV vendors

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 Link

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