Quality Engineer

Principal Responsibilities:

Local Vigilance Officer

• Act as the contact point for local medical gases and medical devices safety issues within normal business hours.

• Implementing pharmacovigilance (PV) and medical device vigilance according to the local vigilance standard operating procedure which is developed based on the local and global vigilance requirement.

• Work with OS QRA in maintaining the local Vigilance system.

• Pharmacovigilance Processes

• Implementing local regulatory and global vigilance requirements.

• Notify Global PV Management or RALIS on the local regulatory development as per requirements detailed in the Linde vigilance standards.

• Report medical gases adverse event and medical device incidents to Global PV Management and local authority, if appropriate

• Identify qualified resources for management of medical inquiries.

• Notifying Global Pharmacovigilance (PV) Management

• Any Adverse Event and Special Situations as defined in the Linde vigilance standards.

• Any deviation from the Pharmacovigilance System in place. This could for instance be processes not implemented in accordance with the global standards and errors or mistakes when performing vigilance related activities.

• Local literature search which results in identification of reportable case(s).

• Market research, patient program, and clinical studies conducted locally

• Medical inquiry which reply is not found in the Company Core Data Sheet (CCDS)

• Safety related medical inquiry

• Post-authorization safety studies requested by a competent authority including the results of such studies.

• Any regulatory action/request involving vigilance within 24-hours from awareness, to ensure that a regulatory response can be prepared within the agreed timelines.

• Any changes in local authority requirements, with an impact on medical safety and vigilance, including case management and reporting requirements.

• Local Pharmacovigilance inspections. All responses concerning Pharmacovigilance related findings must be approved by GSV.

• Due dates for submission of required Periodic Safety Update Reports (PSURs) and other periodic reports, for authorized medicinal products, on a yearly basis and at least 2 months prior to the submission date.; if PSURs is required by the national competent authority.

• Requests for Risk Management System (RMS) and Risk Management Plan (RMP) by national competent authority if RMS and RMP are required by the national competent authority.

• Safety related issues arising in the mass media, which may give Linde an early warning of a medical safety signal or which may escalate to involve for example, an action from the regulatory authorities or litigation.

• Any changes to the local quality system or local regulation that may impact Pharmacovigilance.

• Any new medical gases related updates from the activity of local authority website monitoring.

• Handling of adverse events and special situation cases

• Report Adverse Events as per local and Linde vigilance requirement.

• Follow-up on Individual Case Safety Report (ICSR).

• Ensure personal data is managed according to local data protection legislation.

• Translation to English any information in a local language which is related to medical safety and reporting to GSV.

• Process domestic and foreign cases according to local regulatory requirements, including adverse events, special situations, and medical events.

• Provide GSV with copies of cover letters and acknowledgements for submission of cases to local regulatory authority.

• LVO Training and Qualification

• Maintain curriculum vitae (CV) and Job Description.

• Maintain global LVO training history.

• Complete the required training or reading assigned by Global PV Management timely

• Attend GSV provided annual LVO refresher training

• Non-LVO Healthcare Staff and Third-Party Supplier Training and Qualification

• Identify non-LVOs training needs.

• Translate non-LVOs training materials developed by GSV; as applicable.

• Deliver training to non-LVOs.

• Track training delivered to non-LVOs.

• Market Authorization and Registration

• Notify RALIS (Regulatory Affairs Linde Information System) mailbox and Global PV management any new, amended, renewals and withdrawal of marketing authorizations and PSURs (within 5

working days)

• Communicate any new product registration information update to GSV.

• Respond to authority requests for information with support from Global PV management.

• Prepare list of medical gases and medical devices sold locally.

• Communicate to GSV what medical gases are being sold in a country, regardless of regulatory

• Third-Party Safety Data Exchange Agreements (SDEA)

• Ensure requirement in MS-10115: Management of Linde Safety Data Exchange Agreements is implemented.

• Conduct risk ranking of all healthcare third-party contractors to determine the need to PV training and signing SDEA.

• Keep a tracker for all Third-Party Safety healthcare contractors.

• Review of third-party contractor's agreements to identify the scope of services provided by the third party and conduct risk ranking.

• Review and assure the correct handling of vigilance cases as per local contractual agreements (licensors, contract research organizations, etc.).

• Reconciliate with third-party contractor on the number cases reported Linde every year.

• Other vigilance-related activities

• Assess and track local Market Research, Patient Support Programs and Clinical studies.

• Inform GSV on any Markey Research, Patient Support Programs and Clinical studies involves

Linde medical products.

• Monitor

• Literature search: Monitor relevant scientific and medical publications in local journals for safety related matters concerning Linde products, including case reports.

• Verify literature search information from any third party contracted literature search activity.

• Monitor authority websites on at least a quarterly basis and document review.

• Monitor external regulatory, quality and safety environment.

• Monitor local web site interface for reporting adverse events.

• Quality Incident Management

• Perform quality incident trend analysis and identify any significant trend.

• Discuss the quality incident trend during management review.

• Report the trend to the OS QRA.

• Reconciliation and self -assessment

• Perform reconciliation of the monthly newsletter line listings report (adverse event and literature search line listings). For discrepancies noted recommend a deviation be developed and entered in the deviation tracker

• Perform monthly reconciliation of SDEA Tracker and inform GSV of any changes needed.

• Perform reconciliation of incoming complaints via all channels at least twice a year to ensure that all vigilance related reports (AEs, Special Situation and incidents) have been reported to the LVO.

• Perform reconciliation of medical information request according to Linde standards (RALIS, PSURs, Market Authorizations and Registrations); as applicable.

• Perform annual reconciliation and self-assessment of Pharmacovigilance activities to ensure compliance to Linde vigilance requirements.

• Public Adverse Event Reporting

• Establish public website interface for local adverse event reporting.

• Agency Reporting

• Submit reports to non-EMA regional regulatory agencies, as applicable.

• Medical Safety Profile

• Ensure local compliance with CCDS requirements.

• Ensure local product information is in compliance with RMP commitments; as applicable.

• Periodic Safety Update Reports

• Submit updated PSURs to local Authority timely; as applicable.

• Risk Management Plan

• Ensure implementation of RMS and RMP; as applicable.

• Contact GSV if there is request for Risk Management System (RMS) and Risk Management Plan (RMP) by the national competent authority.

• Global Vigilance Audit by Global Assessment

• Identify CAPA for internal vigilance audit and inspection by the Global Assessment.

• Drive CAPA to closure for internal vigilance audit.

• Communicate completion of deliverables to Global Assessment for internal vigilance audit.

• Third-Party Healthcare Contractors Vigilance Audit

• Audit planning.

• Audit execution.

• Audit finding follow-up: identify CAPA, approve CAPA, follow CAPA to closure, verify implementation of CAPA, audit closure.

• Inspection (Audit performed by authorities)

• Attend local PV inspections by local authority.

• Local Authority inspection finding follow-up: identify CAPA and drive CAPA to closure.