Patient Safety Manager

**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