Patient Safety Officer

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

  • Patient Safety Manager

    9 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...

  • Patient Safety Manager

    2 settimane 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...

  • Global Patient Safety Lead

    3 settimane fa

    Milano, Lombardia, Italia Regeneron Pharmaceuticals A tempo pieno

    About the RoleWe are seeking an experienced Senior Manager of Global Patient Safety to play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the Ophthalmology Therapeutic Area.

  • Junior Health

    7 mesi fa

    Milano, Italia PPG A tempo pieno

    In PPG diamo priorità alla sicurezza e alla conformità in tutte le nostre operazioni. Attualmente siamo alla ricerca di un Junior Health & Safety Officer dedicato da inserire nel nostro team a Milano. Come Junior Health & Safety Officer opererai in stretta collaborazione con i dipartimenti Operations, Maintenance e EHS plant per supportare la consegna e...

  • Junior Operations Safety Officer

    7 mesi fa

    Milano, Italia PPG A tempo pieno

    In PPG diamo priorità alla sicurezza e alla conformità in tutte le nostre operazioni. Attualmente siamo alla ricerca di un Operations Safety Officer dedicato da inserire nel nostro team a Milano. L'Operations Safety Officer opererà in stretta collaborazione con i dipartimenti Operations, Maintenance e EHS plant per supportare la consegna e la conformità...

  • Senior Manager, Global Patient Safety Scientist

    4 settimane fa

    Milano, Italia Regeneron Pharmaceuticals A tempo pieno

    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 assessment....

  • Senior Manager, Global Patient Safety Scientist

    4 settimane fa

    Milano, Italia Regeneron Pharmaceuticals A tempo pieno

    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...

  • Junior Operations Safety Officer

    2 settimane fa

    Milano, Italia Ppg A tempo pieno

    In PPG diamo priorità alla sicurezza e alla conformità in tutte le nostre operazioni. Attualmente siamo alla ricerca di un Operations Safety Officer dedicato da inserire nel nostro team a Milano.L'Operations Safety Officer opererà in stretta collaborazione con i dipartimenti Operations, Maintenance e EHS plant per supportare la consegna e la conformità...

  • Ext. Patient Safety Monitor Sl

    6 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...

  • Ext. Patient Safety Monitor Sl

    3 settimane 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 of...

  • Assistant Inventory Officer

    3 mesi fa

    Milano, Italia Costa Crociere A tempo pieno

    READY TO DISCOVER AN OCEAN OF OPPORTUNITIES? EXCITED TO EXPLORE YOUR POTENTIAL IN A FRIENDLY, INTERNATIONAL, AND WELCOMING ENVIRONMENT? Join Costa today and learn how! Who we are: Ahoy, global community! With 17,000+ professionals from 70 countries, we're a tight-knit crew that celebrates uniqueness. Our ship is fueled by trust, transparency, and positive...

  • Assistant Inventory Officer

    3 mesi fa

    Milano, Italia Costa Crociere A tempo pieno

    READY TO DISCOVER AN OCEAN OF OPPORTUNITIES?EXCITED TO EXPLORE YOUR POTENTIAL IN A FRIENDLY, INTERNATIONAL, AND WELCOMING ENVIRONMENT?Join Costa today and learn how!Who we are: Ahoy, global community!With 17,000+ professionals from 70 countries, we're a tight-knit crew that celebrates uniqueness.Our ship is fueled by trust, transparency, and positive...

  • Pharmacovigilance Officer

    6 mesi fa

    Milano, Italia Ipsen SpA A tempo pieno

    **Pharmacovigilance Officer - Fix-Term Contract (Maternity Cover)** Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly **improving patients’ health and quality of life** and providing them with effective therapeutic solutions...

  • Pharmacovigilance Officer

    3 settimane fa

    Milano, Italia Ipsen Spa A tempo pieno

    **Pharmacovigilance Officer - Fix-Term Contract (Maternity Cover)**Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care.We aim to make a sustainable difference by significantly **improving patients' health and quality of life** and providing them with effective therapeutic solutions for...

  • Documentation Officer

    1 mese fa

    Milano, Italia Buscojobs A tempo pieno

    Work Schedule: Standard (Mon-Fri) Environmental Conditions: Adherence to all Good Manufacturing Practices (GMP) and Safety Standards.Job Description: Documentation Officer Responsibilities: Collaborate with the Goods Entry Team to verify the accurate completion of all attachments, forms, checklists, and other documentation required for storage and customer...

  • Sales Representative

    3 mesi fa

    Milano, Italia Ambu A tempo pieno

    **Sales Representative - Patient Monitoring & Anesthesia - Friuli-Venezia Giulia, Trentino-Alto Adige, Veneto** **(Contratto a Tempo Indeterminato)** Benvenuto nel dinamico mondo di AMBU, dove l'innovazione e l'impegno per l'eccellenza si uniscono per guidare la rivoluzione delle soluzioni mediche! Se possiedi energia, motivazione, intraprendenza e una...

  • Pharmacovigilance Officer

    6 mesi fa

    Milano, Italia Ipsen SpA A tempo pieno

    Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’ health and quality of life and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in...

  • Health & Safety Manager

    8 ore fa

    Milano, Italia David Lloyd Leisure Ltd - Italy A tempo pieno

    **About the Role**: **Who do I report to? **Assistant General Manager **What is the purpose of the job?** Leading the Club team in managing and maintaining a safe facility and ensuring all health and safety policies are adhered to and that our teams are fully trained and confident in operating a safe club at all times. Leading the lifeguard team and...

  • Health & Safety Manager

    8 ore fa

    Milano, Italia David Lloyd Leisure A tempo pieno

    Informazioni sul ruolo**Who do I report to? **Assistant General Manager **What is the purpose of the job?** Leading the Club team in managing and maintaining a safe facility and ensuring all health and safety policies are adhered to and that our teams are fully trained and confident in operating a safe club at all times. Leading the lifeguard team and...

  • Safety Program Coordinator

    3 giorni fa

    Milano, Italia Anser Advisory A tempo pieno

    At Anser Advisory, we strive and succeed by creating smart, dynamic and professionally skilled teams to deliver extraordinary projects for our clients. You will work on interesting projects which will expand your expertise and hone your technical skills through the ability to access the most advanced technology on the market. Your successful impact will help...