I- Common missions related to the function:

1. Participate to the scientific and international regulatory intelligence. Provide expertise and support to analyze the impact of new scientific or regulatory information. 
2. Maintain and update the quality documentation on his/her perimeter.
3. Check the compliance to quality referential on his/her perimeter.
4. Participate to the preparation and conduct of vigilance audits and inspections. Participate to the implementation and follow-up of corrective and preventive actions.
5. Elaborate or contribute to the elaboration of training materials related to his/her field of activity.
6. Inform the Head of Global Vigilance and Medical Information (GVMI) department of the Group and/or the Global Head of Regional Vigilance & Partnership and/or the APAC Vigilance Manager of any emerging issue, any incident or any information which may influence the security of the medicinal products or the medical devices or may need to be reported to health authorities.

 II- As Guerbet Korea Affiliate’s LRPPV (Local Responsible Person for Pharmacovigilance (PV)) 

(geographical perimeter = South Korea)

1. Be responsible for ensuring that the affiliate and the local distributors (partners) comply with PV obligations, by implementing the Safety Data Exchange Agreement (SDEA) and their subsequent amendments (customization of the template according to local regulations) and ensuring their compliance with the quality documents and the local regulations. 

1. Ensure the compliance of the below PV operations. 

• PV case management

Collect local PV/MDV cases (reports of Adverse Drug Reactions (ADRs) / 

• Adverse Events (AEs) / special situations / incidents) from healthcare professionals, patients, scientific and medical literature, Competent Authorities and affiliates websites, medical information enquiries (MIEs), product quality complaints (PQCs), customer relationship management (CRM) tool, market research programs, and clinical studies.
• Report the PV cases to the Global Vigilance department.
• Perform a local medical assessment of the PV cases and submit them to the Competent Authorities after they were processed by the GVMI team.
• Record the PV cases in the affiliate PV case log.
• Perform follow-up activities for local PV cases.
• Perform local searches of PV cases in the domestic published literature, including the collection of follow-up information from the authors.
• Perform the submission of foreign serious cases by local regulation. 

• Interactions with healthcare professionals and Competent Authorities 

• Submit periodic safety reports, response documents, and any information regarding changes in benefit/risk ratio of the products to the appropriate Competent Authorities.
• Handle the product risk management plan and their amendment preparation in collaboration with the GVMI and the company with global partnership and submit those to Competent Authorities and manage risk minimization activities.
• Handle the preparation of the periodic risk management plan implementation report in collaboration with GVMI and the company with global partnership and submit the report to Competent authorities as required in local regulation.
• Answer to product-related safety questions from healthcare professionals with the support of the GVMI department. 
• Report safety information to healthcare professionals via the PV Contact Persons of the distributors. 

• Other PV-related operations and Quality Assurance in PV

• Be responsible for the signature and implementation of a Safety Data Exchange Agreement (SDEA) between the affiliate and the GVMI department.
• Be responsible for the signature and implementation of Local SDEAs with all affiliates’ partners in charge of product distribution and/or promotion.
• Perform reconciliations with other data collection systems (MIE, PQC, CRM…).
• Set-up a local system for the detection and management of safety signals, emerging safety issues or public health threats.
• Ensure local regulatory intelligence on PV matters.
• Ensure business continuity in PV activities at affiliate’s level.
• Ensure global oversight on the local PV system through Safety Board meetings.
• Ensure regular PV trainings of the affiliate’s staff as well as PV Contact Persons of the partners. 
• Participate in the revision of the safety sections of the local Product Information (SmPC) in collaboration with local Regulatory Affairs.
• Ensure the control of safety operations through self-inspections. 
• Record and store safety data and documents in secured formats and repositories.
• Ensure PV audits are conducted at affiliate and partners’ level, and work for CAPA development and implementation. 
• Establish and maintain a local QMS system for PV by creating and revising the local standard quality documents in compliance with Guerbet HQ standards as well as local regulations.
• Ensure the compliance of PV operations at affiliate’s and handle the deviations on nonconformities. 
• Support the clinical team on local implementation of post-market requirement on phase IV and PMS studies, and their safety reporting to Competent Authority.
• Manage the submission of all regulatory documents to MFDS as imposed as post-market requirements in collaboration with local Regulatory Affairs. 
• Ensure the safety document preparation and review for drug renewal submission as required by local regulation. 

III- Specific missions for this position

• Act as LRPPV of pharmaceutical drug declared to local authority as required by local regulation, and take overall responsibilities defined for Local Responsible Person for Pharmacovigilance (LRPPV) in Korea and Guerbet.   
• Is the Contact Person of the MFDS for any PV matter related with Guerbet pharmaceutical Products. 

 IV- As Guerbet Korea Affiliate’s LRPMV (Local Responsible Person for Medical Device vigilance (MDV)) 

• Act as the Local Responsible Person for Medical Device Vigilance (LRPMV) Deputy for managing the MDV system, and back-up the LRPMV Deputy’s roles in Guerbet Korea Affiliates.

Support the Local MDV system management and operation by LRPMV