SOUTH – EUROPE PHARMACOVIGILANCE MANAGER
Per realtà multinazione leader nel settore medicale.
The Manager for Pharmacovigilance for Southern Europe cluster (Italy, Spain, Portugal and Greece) is responsible:
• In collaboration with Global Patient Safety (GPS), EMEA PS Head and the EUQPPV, to maintain an efficient local pharmacovigilance system meeting national and European regulations and in compliance with Company Pharmacovigilance (PV) procedures.
• To fulfill the requirements of the local legislation as the Local PV contact in Italy.
• To provide the Italian regulatory authorities in cooperation with GPS and the EUQPPV with any information relevant to the benefit/risk evaluation of a medicinal product in a timely fashion.
• To act as regulatory authority contact in Italy for any pharmacovigilance issues related to therapeutic products licensed in Italy.
• To ensure appropriate contacts with SE Cluster General Manager and other relevant internal partners in main and associated countries, such as Medical Affairs, Commercial, Regulatory, Legal and Quality.
• To manage the PV cluster team.
• To implement cluster operating model and support improvement and harmonization of processes and procedures across the cluster.
ESSENTIAL DUTIES AND RESPONSIBILITES
• To have an oversight of all PV activities performed in the cluster,
• To manage the PV team and provide team with an appropriate training and coaching as necessary,
• To prepare and perform PMOs/PMPs aligned with Global Goals,
• To manage PV budget for the cluster,
• To keep up to date her own training records,
• To escalate to EU QPPV, EMEA PS Regional Head and Global PS any safety related issues arisen in Southern Europe cluster without delay,
• To collaborate closely with PV Cluster heads in EMEA region as member of the leadership team, and with the EUQPP office and GPS stakeholders, as adequate,
• To represent Patient Safety in SE Leadership Team (SELT),
• To represent PV in national trade association bodies, as needed,
• To be aware of all activities and communication on PV topics/issues with local regulatory authorities and to ensure coordination of actions regarding enquiries in cooperation with EUQPPV, Global PS and EMEA PS Regional Head,
• To proactively inform management and EUQPPV about any PV related issues in cluster and changes in legislation without delay.
2. Operational Activities
• To support, supervise and monitor PV staff in routine AE case processing activities such as ensuring monthly local QC, monitoring country compliance reports, ensuring that all authorities queries are answered in a timely fashion,
• To ensure submission of all reportable ADRs to the National Competent Authorities according to the national regulations and answer any subsequent questions in collaboration with EU QPPV and the GPS organization,
• To answer safety questions from Health Care Professionals with the support of the GPS organization, if necessary,
• To closely monitor PV compliance in the cluster and make all efforts to achieve high compliance rates.
3. Local Clinical Trial Activities
• To timely review safety sections of local study protocols prior to study start in order to ensure compliance with PV requirements, as adequate, to assist EUQPPV regarding approval of protocols via grant procedure and communicate relevant information to all relevant stakeholders, when needed,
• To ensure training of vendor staff, when appropriate
To monitor PSURs submission compliance in Italy.
5. Other PV Activities:
• To ensure PV training for local Company employees and PV staff is performed and documented,
• Ensure support to business in regards to Market Research and Patient Support Programs and any other business initiative and provide assessment from PV perspective,
• To receive information on local license agreements by internal stakeholders (Legal, Business, QA) and ensure that Safety Data Exchange Agreements and other PV agreements are in place/ maintained in liaison with EMEA PV Agreements team,
• To ensure 24 hour coverage is in place after business hours,
• To ensure audit and inspection readiness,
• To coordinate actions with relevant stakeholders in case of audits and inspections in the cluster and provide answers to audit/Inspection reports,
• To implement and coordinate corrective actions in case of internal audits and or external inspections in cooperation with GPS/ EU QPPV/EMEA PS Head,
• To participate in the management of a crisis upon request from the Cluster General Manager,
• To ensure proper cluster CAPA management,
• To create, maintenance and/or implementation of PV local and/or cluster SOPs mandatory forms and other relevant documents,
• To support CCDS review,
• To support and participate in regional or global projects, as needed,
• To get from Regulatory Affairs an updated list of all medicinal products licensed in Italy and access to their applicable SPCs,
• To review safety section of local non-interventional studies (Post-Authorization Safety Studies) before their implementation and of new local clinical trials (interventional Studies) and Investigational Initiated studies (IIR) and transmit the synopsis or protocol to the EUQPPV office,
• To receive information on local agreements with Third parties, Patient Support/Market Research Programs and ensure that PV clauses are in place/ maintained when applicable and liaise with EMEA SDEA team,
• To inform Company GMs and BUD on any major or relevant change of the safety information related to the products marketed.
6. Activities related to associated countries (Spain, Portugal and Greece):
• To collaborate closely with associated countries on above activities and provide advice towards the establishment concerning the Pharmacovigilance system,
• To ensure that all activities described for the main countries are conducted.
EDUCATION AND/OR EXPERIENCE
• The function requires a degree in Medicine or Pharmacy.
• Minimum of 5 year professional experience in PV is required in this field of activity.
• Team management experience on site and or remote.
• Working experience with international exposure (e.g. project lead)
Additional knowledge or skills gained through a combination of academic study, job experience is required, e.g.:
• Outstanding team management and leadership skills.
• Ability to communicate efficiently and in writing in local language (Italian) and in English. Other languages Spanish/Portuguese/Greek is a plus
• Good negotiation skills.
• Ability to liaise with the different functions ie GM, Regulatory Affairs, Country Quality Assurance, Businesses, Legal Affairs.
The problem solving capabilities for this position is:
- To be effective in the communication with the Health Authorities and Health Care Professionals,
- To be effective in the interaction with the different functions, networking
- To be effective in managing people.
- A perfect understanding of existing regulations,
- A perfect understanding of the SOPs,
- A good knowledge of the Baxter products.
Sede di lavoro: ROMA
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