PV Safety Assessment Specialist

Recordati

Milan, Italy

Job Purpose

We are looking for a PV Safety Assessment Specialist to monitor the products safety profile ensuring an effective and compliant management of all pharmacovigilance and vigilance activities related to Benefit-Risk assessment.

Key Responsibilities

Evaluation of the safety profile of medicinal products (corporate-HQ and local Italian), medical devices, cosmetics and food supplements applied to pre-marketing (clinical studies) and post- marketing;
In particular:
- planning and generation of safety documents relevant to the Benefit-Risk assessment for medicinal products of HQ competence (e.g., PSUR, DSUR, RMP and related risk minimisation measures, signal detection reports);
- planning and preparation of the safety documents relevant to the Benefit-Risk assessment for medical devices, food supplements and cosmetics (e.g., Trend Analysis, PSUR, PMS plan, cumulative safety reviews);
- generation of Safety Management Plans for interventional and non-interventional studies/market research/patient support programmes for medicinal products, medical devices, food supplements and cosmetics, as applicable;
- regular review of the safety data, including EVDAS, to detect new safety signals (signal detection process) and evaluation of Benefit-Risk ratio for medicinal products of HQ competence;
- support to the ICSRs processing group for the assessment of relevant individual cases;
- support for the Clinical Overview and any other safety analysis documents preparation relevant to regulatory procedures for medicinal products of HQ competence (e.g., MAs, variations, SmPC harmonization);
- support in reviewing and updating safety sections of the Technical File for medical devices and dossier of non-pharmaceutical products;
- support to the preparation of Clinical Evaluation Report (CER), Post-market Clinical Follow-up (PMCF) and PMCF studies;
- bilateral exchange of safety information with Affiliates and Partners in accordance with the enforced Safety Data Exchange Agreements;
- collaborate with the Safety Medical Advisor for the analysis and medical review of the generated documents;
- review and update of the safety section of the Summary of Product Characteristic (SmPC) and of Company Core Data Sheet (CCDS) for products of HQ competence and of Investigator's Brochure (IB) for investigational products, in collaboration with R&D and Regulatory Department;
- management of safety issues associated to medical enquires, technical complaints and product recalls in agreement with the enforced legislations;
- management of safety issues related to clinical studies, including documentation revision, in agreement with the enforced legislations and company SOP/WI.
Training for continuous education of internal personnel and sales force on safety issues related to products of competence;
Support the Affiliates for any activities related to Benefit-Risk assessment of medicinal products, medical device, cosmetics and food supplement;
Support in reviewing safety relevant sections of marketing and promotional materials;
Generation and updating of SOPs/WIs concerning pharmacovigilance and vigilance processes and activities.