Responsibilities：

1 Establishing appropriate quality processes by means of suitable training and generation of standard operating procedures and working instruction guides on pharmacovigilance at a local level, consistent with global Bracco procedures and local requirements;
2 Implementing an efficient communication system which guarantees that all safety information (i.e. adverse events/drug reactions (AE/ADRs) and special situations) collected from any source within the territory is promptly forwarded to the relevant DSU;
3 Ensuring that roles and responsibilities for Affiliate personnel handling pharmacovigilance data and pharmacovigilance-related documents are detailed in the applicable Job Descriptions and any other related documents;
4 Ensuring that all local staff (employees/consultants/contractors) is trained on local pharmacovigilance Standard Operating Procedures (SOPs);
5 Ensuring that all consultants/contractors, to whom pharmacovigilance activities are outsourced, are informed of their duties with regards to safety information reporting to Bracco Local DSO/person responsible for pharmacovigilance;
6 Ensuring a process for handling the review of local commercial agreement before their approval in order to issue local pharmacovigilance agreements as applicable and the creation of local service agreement covering any local pharmacovigilance activity outsourced;
7 Having a local process in place which includes a description of their strategy for retrieving from local publications (including magazines, congress communications, etc.) all possible adverse events (AEs)/ADRs, emerging safety issues, and special situations related to Bracco medicinal products. This search shall be conducted on a weekly basis, unless the Local DSO/Person Responsible for Pharmacovigilance confirms that such journals are published at different intervals (e.g. monthly, quarterly, etc.). The local journals should be those required to be screened as per local legislation or relevant for the portfolio of the MAH;
8 Implementing a local system for tracking and monitoring safety information exchanged among the different functions;
9 Routine reconciliation with the relevant DSU, with the relevant representative of quality assurance handling local product quality complaints, with Global Commercial Operation regarding possible information that could be entered in the Customer Relation Management system, and with other systems/functions (e.g. medical information, etc.);
10 Providing , on a regular basis, with all information needed for inclusion in the PSMF, or similar documents, as requested by local legislation;
11 Providing the Head of CDSP/QPPV, every two months with information pertaining to all the relevant activities performed at the Affiliate level with an impact to the Pharmacovigilance System.
12 Submitting expedited and aggregate safety reports to the local Regulatory Authority, if not performed by the relevant DSU;
13 Archiving all Pharmacovigilance-related documents and ICSR source documents in a secured manner for the entire life cycle of the applicable Product and for at least another ten (10) years after the product Marketing Authorization (MA) has ceased to exist. If local legislation requires longer periods, the Affiliate must comply with their local legislation;
14 Acting as the local contact point for the Territory Regulatory Authority, if required by local legislation;
15 Preparing country-specific safety reports for their Regulatory Authorities, in collaboration with relevant DSU where applicable (based on global PBRERs in case of global products);
16 Maintaining awareness of current national legislation and regulatory guidelines and promptly informing CDSP of any changes;
17 Contributing to the maintenance of the local Pharmacovigilance Quality System (i.e. being the author of the local pharmacovigilance procedures), particularly, ensuring that the following processes are covered by local procedures:
? Quality, correctness, timeliness of safety reporting (if applicable);
? Compliant safety data collection, tracking, filing and archiving in compliance with applicable legal requirements, with knowledge and respect for data integrity;
? Uninterrupted availability of media and support for capture of incoming safety information (phone/fax lines, websites, databases, contact cards, forms, etc.);
? Training of all parties involved in the local Pharmacovigilance System, including contracted parties to fulfill their role in the Pharmacovigilance network;
? Monthly reconciliation of adverse events collected by the Affiliate with the relevant DSU and any other departments;
? Periodic local literature search;
? Periodic reporting of local pharmacovigilance activities and compliance data to Affiliate management and to the Head of CDSP/QPPV.
? Recommending the implementation of corrective measures to improve compliance as needed in collaboration with the relevant DSU.
? Preparing and hosting local PV inspections in collaboration with CDSP.

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