PV Safety Assessment Specialist

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.

Required Education

Scientific degree 

Master in pharmacovigilance is a plus 

Required Skills and Experience

At least 3 years experience in a similar role

Good knowledge of Argus or similar PV Database

Able to work in a team and problem-solving skills.

Past experience in Regulatory Affairs is a plus

Analytical skills

Required Languages

Good knowledge (written and oral) of the English language is required. Further knowledge of languages is a plus.