Patient Safety Manager

8 mesi fa

Milano, Italia AstraZeneca A tempo pieno

**Patient Safety Manager (PSM)**

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.

At AstraZeneca, we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve, no matter where you start with us.

The **Patient Safety Manager** role has responsibility in Italy for ensuring that the collection, follow-up, and onward transmission within AZ, and submission to health authorities of adverse drug event reports, are managed in compliance with local regulations and company policies/procedures at a local, regional and global level and in accordance with any PV agreements with third party business partners.

The PSM is responsible for supporting the Head of Patient Safety Italy / Local Contact Person for PV to have appropriate local PV system oversight. This includes responsibility for ensuring the processes and systems necessary for the Local Contact Point and deputy to fulfill their responsibilities, for the management of AE reports, comply with global and local requirements; remain current with applicable regulations; and are followed consistently, by ensuring delivery of any training necessary.

The PSM tracks system performance including regulatory compliance and provides periodic reports to management. By attention to detail, quality and completeness, the PSM ensures that adverse event information received locally contributes to AZ knowledge of the safety profile of its products. The PSM reports into

Head of Patient Safety Italy and is part of the Global Patient Safety Organisation Patient Safety Italy has a dotted line reporting to AZ EUQPPV.

**Principal Responsibilities**
- Acts as the deputy of the Local Qualified Person/Local Contact Person for Pharmacovigilance towards local Health Authorities in Italy.
- Ensures compliance with local PV regulatory requirements, as well as AZ requirements.
- Oversees the collection of AEs from every source into AE form, AE Intake tool or Argus and, as appropriate, onward forwarding of the AE information to Global Safety, Data Entry Site (DES).
- Develops and maintains effective business relationships with AZ and if applicable external parties in addition to tracking performance metrics including regulatory compliance.
- Maintains local source documents in accordance with applicable record retention requirements.
- Ensures business continuity for collection & reporting of AEs within the country.
- Acts as deputy for specific Therapeutic Area (TA) of the primary contact for GPS.
- Executes CAPA plans relevant to the role as necessary, and oversees the development, implementation and execution of any necessary CAPA plans by third parties that support the local safety area.
- Maintains and seeks out a thorough understanding of global and local requirements that relate to the local safety role, identifying and communicating emerging needs to introduce process changes to remain compliant.
- Provides PV expertise to the selection and qualification of any Patient Support Program organized in Italy.
- Performs root cause analysis of deviations relevant to local PV processes.
- is the point of contact for specific Therapeutic Area (TA) to provide local expertise on AE reporting processes and standards to local country staff and related contractors/vendors according to AZ standards and local regulations.
- Maintains oversight of Local Safety Data Exchange Agreements.
- Shares best practices with other affiliates in the EU region.
- Streamlines and develops local processes as required.
- Supports local implementation of RMP.
- Oversees Local literature screening process.
- Ensures local regulatory intelligence. Assesses and oversees implementation of updated local PV regulatory requirements to the local PV system.
- Ensures reconciliations with interfaces who shall receive potential adverse events (i.e. Medical Information, Product Quality complaints).
- Represents GPS during local Pharmacovigilance audits and inspections.
- Performs or ensures the local translation and adaptation of the applicable RMMs for Italy.
- Acts as the expert and contact for Therapeutic Area Heads with regards to RMP requirements and specificities in Italy.
- Coordinates harmonized Risk Management Plan training and support development of training material.
- Contributes to local parts of the AZ PSMFs.

**Qualifications**
- Extensive experience in Pharmaceutical industry or equivalent with the majority of the experience in a Pharmacovigilance functional role.
- Experience as Local Contact Person for PV Italy is an asset
- Proven expertise and experience in pharmaceutical regulations and R&D processes.
- Fluency in Italian and English language required.

**Education**
- University degree - medical, pharmaceutical, or other healthca

  • Patient Safety Officer

    7 mesi fa

    Milano, Italia AstraZeneca A tempo pieno

    **Patient Safety Officer (PSO)** At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. At AstraZeneca, we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most...

  • Senior Manager, Global Patient Safety Scientist

    1 mese fa

    Milano, Lombardia, Italia Regeneron Pharmaceuticals Inc. A tempo pieno

    Job Summary:We are seeking a Senior Manager of Global Patient Safety who will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the Ophthalmology Therapeutic Area.This includes safety data aggregation, review, and analysis to support appropriate safety interpretation and benefit-risk...

  • Patient Advocacy Manager

    6 mesi fa

    Milano, Italia AstraZeneca A tempo pieno

    **Patient Advocacy Manage**r** At **AstraZeneca** we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us. Welcome to **MIND (Milan)**, one of over 400 sites here at AstraZeneca,...

  • Patient Manager

    3 mesi fa

    Milano, Italia GRUPPO SAN DONATO A tempo pieno

    **Smart Dental Clinic,** tra i più importanti network di centri odontoiatrici in Lombardia, ricerca un* **Patient Manager **che rappresenta il punto di riferimento tra paziente e staff professionale odontoiatrico, interpreta i valori dell'organizzazione e garantisce al paziente l'esperienza di cura positiva. La figura professionale verrà inserita nelle...

  • Ext. Patient Safety Monitor Sl

    5 mesi fa

    Milano, Italia BI Italia Spa A tempo pieno

    **THE POSITION**: **ONE YEAR AGENCY CONTRACT **Main responsibilities**: - Identification, evaluation and management of safety data from any source and distribute to Global data entry after management in the local pharmacovigilance system of Global Safety Platform. - Safety report analysis and management of the follow-up requests, if applicable. - Screening...

  • Patient Journey Manager

    7 mesi fa

    Milano, Italia Kyowa Kirin International A tempo pieno

    Overview: **Job Purpose**: - Face of KKI, as single point of contact for HCPs and associated stakeholders. A Field based omnichannel conductor, with intimate knowledge of entire patient journey, focused on delivering a personalized, high value customer experience, shortening the patient journey and improving outcomes aligned with KKI’s Rare Disease...

  • Health and Safety Manager

    1 mese fa

    Milano, Lombardia, Italia Amazon A tempo pieno

    Job SummaryWe are seeking a skilled Workplace Health and Safety Manager to join our team at Amazon Logistics in Italy. As a key member of our safety team, you will be responsible for driving health and safety initiatives across our AMZL sites.Key ResponsibilitiesAssist in the delivery of safety performance and monitoring, in line with personnel, team, and...

  • Functional Safety Manager

    6 mesi fa

    Milano, Italia INTEL A tempo pieno

    Responsibilities and Duties The Functional Safety Manager is responsible for the planning and coordination of the functional safety activities during the product development phases, i.e. the product development at the system, hardware or software level, in which the organization is involved and according to the defined functional safety lifecycle. In...

  • Patient Journey Manager

    7 mesi fa

    Milano, Italia Kyowa Kirin International A tempo pieno

    Overview: At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients,...

  • Health and Safety Manager

    3 settimane fa

    Milano, Lombardia, Italia Amazon A tempo pieno

    Job SummaryAmazon is seeking a skilled and proactive Workplace Health and Safety Manager to drive health and safety initiatives across our AMZL sites in Italy.About the RoleWe are looking for an experienced and innovative individual who is passionate about Health and Safety in a professional context. As a key member of our team, you will assist in the...

  • Patient Care Manager

    6 mesi fa

    Milano, Italia GRUPPO SAN DONATO A tempo pieno

    La **Direzione di International Business Development **si occupa della gestione dei pazienti internazionali che provengono dalle seguenti aree geografiche**:Europa (prevalentemente dell'Est), Nord e Sud America, Australia e Nuova Zelanda**. Il numero medio in un anno di pazienti internazionali che accolgono all'interno delle strutture è di circa **405**...

  • Functional Safety Manager

    1 mese fa

    Milano, Italia Https:Www.Energyjobline.ComSitemap.Xml A tempo pieno

    Position description Category: OPERATIONS - ENGINEERING/PRODUCTION Job title: Functional Safety Manager - Automotive Contract: Permanent contract Contractual hours: Full time Job description: Akkodis è un leader globale nel mercato dell'ingegneria e della ricerca e sviluppo che mira ad accelerare l'innovazione e la trasformazione digitale utilizzando la...

  • Corporate Health&safety Manager

    6 mesi fa

    Milano, Italia AIMS A tempo pieno

    For a Multinational Company operating in Life Science Sector, we are looking for the: **CORPORATE HEALTH&SAFETY MANAGER**: **Main responsibilities**: **Responsibilities**: - Develop and implement health and safety policies, procedures, and guidelines in alignment with regulatory requirements and best practices. - Conduct regular risk assessments and audits...

  • Functional Safety Manager

    1 mese fa

    Milano, Italia Https:Www.Energyjobline.ComSitemap.Xml A tempo pieno

    Position description Category: OPERATIONS - ENGINEERING/PRODUCTIONJob title: Functional Safety Manager - AutomotiveContract: Permanent contractContractual hours: Full timeJob description: Akkodis è un leader globale nel mercato dell'ingegneria e della ricerca e sviluppo che mira ad accelerare l'innovazione e la trasformazione digitale utilizzando la forza...

  • Health & Safety Manager - Construction

    1 mese fa

    Milano, Italia Copperpeg A tempo pieno

    This Data centre consultancy with a new office in Milan is looking for an Italian speaking HS Manager to support large construction projects in Italy.The RoleWorking collaboratively with clients, general contractors, and subcontractors, you will be responsible for promoting a culture of safety, ensuring that all members of the site teams and the public...

  • Regional Health and Safety Manager

    1 mese fa

    Milano, Lombardia, Italia Amazon A tempo pieno

    Job Summary: We are seeking a skilled Workplace Health and Safety Manager to join our Amazon Logistics team in Italy. As a key member of our health and safety team, you will be responsible for driving health and safety initiatives across our AMZL sites in Italy.Key Responsibilities:Assist in the delivery of safety performance and monitoring, in line with...

  • Health & Safety Manager - Construction

    2 mesi fa

    Milano, Italia Copperpeg A tempo pieno

    This Data centre consultancy with a new office in Milan is looking for an Italian speaking H&S Manager to support large construction projects in Italy. The Role Working collaboratively with clients, general contractors, and subcontractors, you will be responsible for promoting a culture of safety, ensuring that all members of the site teams and the public...

  • Health & Safety Manager - Construction

    2 giorni fa

    Milano, Italia Copperpeg A tempo pieno

    This Data centre consultancy with a new office in Milan is looking for an Italian speaking H&S Manager to support large construction projects in Italy.The RoleWorking collaboratively with clients, general contractors, and subcontractors, you will be responsible for promoting a culture of safety, ensuring that all members of the site teams and the public...

  • Health & Safety Manager - Construction

    2 settimane fa

    Milano, Italia Copperpeg A tempo pieno

    This Data centre consultancy with a new office in Milan is looking for an Italian speaking H&S Manager to support large construction projects in Italy. The Role Working collaboratively with clients, general contractors, and subcontractors, you will be responsible for promoting a culture of safety, ensuring that all members of the site teams and the public...

  • Health & Safety Manager - Construction

    5 mesi fa

    Milano, Italia Copperpeg A tempo pieno

    This Data centre consultancy with a new office in Milan are looking for an Italian speaking H&S Manager to support large construction projects in Italy.The Role Working collaboratively with clients, general contractors and subcontractors you will be responsible for promoting a culture of safety, ensuring that all members of the site teams and public remain...