Deputy Eu Qppv

vor 5 Monaten

Munich, Deutschland Sandoz International Vollzeit

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Join us as a Founder of our ‘new’ Sandoz

**Your job purpose**:
The Deputy EU-QPPV for Sandoz fulfill all the requirements of this role as indicated in the Guidelines on Good Pharmacovigilance Practice (GVP), either directly or through supervision.

The deputy EU-QPPV is responsible for supporting the EU-QPPV in:

- Establishing and maintaining the global Sandoz Pharmacovigilance (PV) system for medicinal products in compliance with GVP requirements.
- Having oversight of the safety profiles and any emerging safety con-cerns in relation to the medicinal products and combined medical devices for which Sandoz holds marketing authorizations.
- Having oversight of the quality management system for the PV system, in collaboration with the QA function.
- Acting as a single contact point in Sandoz for the EU/EEA Competent Authorities and for the UK national competent authority on a 24-hour basis.
- Acts as Quality System Owner for the Sandoz Vigilance System.

**Your key responsibilities**:

- Act as deputy EU-QPPV for Sandoz to fulfill role requirements as indicated in the Guidelines on Good Pharmacovigilance (PV) Practice (GVP), directly or through supervision:

- Single contact point in Sandoz for EU/EEA Competent Authorities on a 24-hour basis and manage/cascade safety related requests for systems or drug safety related in-formation to ensure any requests are answered fully and promptly.
- Assess impact of new PV-related legislation with focus on EU/EEA and provide support to other functions on strategic impact of any changes.
- Oversight of safety profiles and any emerging safety concerns in relation to medicinal products for which Sandoz holds marketing authorizations.
- Collaborate as required in audits / inspections and response processes.
- Oversight of the quality management system for the PV system, in collaboration with the QA function.
- To establish and maintain a system which ensures that information about all suspected adverse reactions which are reported to the personnel of the Marketing Authorization Holders (MAHs), and its medical representatives, is collected and collated in order to be accessible at least at one point within the European Un-ion/European Economic Area (EU/EEA) and the UK.
- To ensure a complete oversight of the structure and performance of the Sandoz global PV system, in order to promote, maintain and improve compliance covering the following aspects:

- Quality control and quality assurance/audit plan and audit reports;
- Global working procedures and databases operations;
- Expediting ICSR reporting and aggregate reports (PSURs, DSURs and RMPs) in relation to quality, focusing on accuracy, completeness and timeliness;
- Training of personnel in relation to PV and Risk Management
- Licensing agreements;
- Post-authorisation safety studies, with appropriate input (including at CMO & PS Leadership Meetings) as required.
- To ensure timely and quality preparation (together with PV, Regulatory Affairs (RA) and Medical Safety) the appropriate medical input to PV reports including:

- Individual Case Safety Reports (ICSRs)
- Periodic Safety Update Reports (PSURs)
- Company-sponsored post-authorization safety studies (PASS)
- Risk Management Plans (RMPs) for Competent Authorities of the Member States where the medicinal product is au-thorized, and for the UK National Competent Authority.
- To ensure (through supervision), that the post-authorisation commitments are ful-filled completely together with Regulatory Affairs, Medical Safety and Safety Sciences, with appropriate medical input.
- To ensure that any PV request from the EU/EEA Competent Authorities, or from UK National Competent Authority, for the provision of additional information necessary for the evaluation of the benefits and the risks afforded by a medicinal product is answered fully and promptly, including the provision of information about the volume of sales or prescriptions of the medicinal product concerned.
- To conduct continuous overall PV evaluation during the post-authorization period. This includes oversight of PV operations in Europe/EEA and non-EU/EEA countries with QPPV requirements together with PV, Safety Operations & Compliance, Medical Safety & Risk Management, Regional and the Country Patient Safety Head network in order to ensure complete oversight of the structure and performance in country systems and across Patient Safety.
- To collaborate as required in audits/inspections and response processes in the EU/EEA region and non-EU/EEA countries with local QPPV requirements together with Sandoz Global Development and UK Development QA and Regional Pharmacovigilance/Quality Head, and UK Head of Safety/ UK Head of Quality.
- To assess the impact of new pharmacovigilance related legislation with focus on EU/EEA and provide strategic support to Sando

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