EU-QPPV & Head QPPV Office (d/f/m)

at  Sandoz

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Join us as a Founder of our ‘new’ Sandoz!

MAJOR ACCOUNTABILITIES:

• 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 information 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
• Talent / career development and performance management of teams
• To establish and maintain a system which ensures that information about all suspected adverse actions which are reported to the person 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 Union/European Economic Area (EU/EEA).
• To ensure a complete oversight to 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 data bases 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;
• Licensing agreements;
• Post-authorization 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)
• To ensure (through supervision), that the post-authorization commitments are fulfilled 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 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 GDD and Regional Pharmacovigilance/Quality Head.
• To contribute (as a member) to the Medical Safety Review Board and Product Stewardship Board and to ensure complete awareness of emerging safety concerns and safety profiles relating to medicinal products for which Sandoz MAHs hold authorizations together, with appropriate medical input into urgent EU/EEA regulatory actions and information flow to EU-QPPV Country Patient Safety Head (CPSH)network, as required (together with HPSs).

Essential Requirements:

• MD preferred or advanced science degree in Life Sciences
• Management training and experience
• High level of expertise in PV, including aspects of medical safety, gained in a European environment (minimum of 10 years), including preferably experience in a major EU/EEA
• Excellent knowledge of European regulatory requirements relating to PV
• PV systems experience (covering compliance, databases, procedures, QA, training)
• Management experience at managing drug safety or RA team (line or functional management)
• Experience in the area of audits/inspections
• Ability to effectively communicate and influence at all level

YOUR KEY RESPONSIBILITIES:

Your responsibilities include, but not limited to:

WHAT YOU’LL BRING TO THE ROLE:

Essential Requirements:

• MD preferred or advanced science degree in Life Sciences
• Management training and experience
• High level of expertise in PV, including aspects of medical safety, gained in a European environment (minimum of 10 years), including preferably experience in a major EU/EEA
• Excellent knowledge of European regulatory requirements relating to PV
• PV systems experience (covering compliance, databases, procedures, QA, training)
• Management experience at managing drug safety or RA team (line or functional management)
• Experience in the area of audits/inspections
• Ability to effectively communicate and influence at all levels