Maidenhead, Maidenhead, United Kingdom
Are you looking for a rewarding career in a market-leading and innovative company?
Seqirus is the new global company created from the combined strength and expertise of bioCSL and the influenza vaccines business formerly owned by Novartis. In July 2015, bioCSL and the influenza vaccines of Novartis joined forces to create Seqirus, now the second largest influenza vaccine company in the world. With extensive research and production expertise and manufacturing plants in the US, UK, Germany and Australia, Seqirus is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. Seqirus has a workforce of over 2,000 employees, significant manufacturing capacity and a commercial presence in 20 countries.
Currently for our office in Maidenhead (UK), we are looking for a: EU QPPV Office Manager
Scope of the role:
Performs per delegation the operative duties of QPPV as described in EU legislation to ensure compliant implementation and maintenance of the pharmacovigilance related regulatory requirements for Seqirus products. Supports the European Union Qualified Person for Pharmacovigilance (EU-QPPV) in the management of office systems and procedures to ensure full compliance with European regulations, including guidelines on Good Pharmacovigilance Practices (GVP) and international regulations.
1. Is the back-up for the EUQPPV in her/his absence and therefore bound to the same level of information and responsibilities. Is the primary company contact for EMA and EU country agencies, in the absence of the QPPV on a 24/7 basis
2. Develop and maintain at all times a complaint Pharmacovigilance System Masterfile (PSMF) and Pharmacovigilance System Summary for the Pharmacovigilance System at Seqirus and coordinates of the maintenance of the appendices from various contributors
3. Ensure that the EU-QPPV has full oversight of all aspects of structure and performance of the Seqirus Pharmacovigilance System, specifically:
• Ensures appropriate processes, resources, communication mechanism and access to all sources of relevant information required by the EU-QPPV;
• Establishment and maintenance of EU-QPPV Office as key interface within company (across all relevant functions);
• Review of EU-QPPV system oversight tools, including all system compliance information received highlighting non-compliance to EU-QPPV;
• Facilitates review, signature (if required) and proper archiving of all EU-QPPV Office outputs to enable rapid access at all times;
• Acts as gatekeeper for all information received as hardcopy at the EU-QPPV Office and electronically through the QPPV mailbox
4. Maintains Eudravigilance registration details of EU-QPPV, Deputy and all other Users.
5. Work closely with the Head of Regions and the Quality & compliance manager to ensure QPPV oversight of PV activities worldwide
6. Supports all pharmacovigilance inspection interactions with EMA / EU-EEA competent Authorities to facilitate timely submission of required documentation and completion of corrective actions, in collaboration with PVO, Clinical Quality Assurance (CQA) and EU-QPPV; Coordinates activities for pharmacovigilance inspections which are conducted in the EU in close cooperation with the EU QPPV and CQA.
• 5 to 7 years of PV experience in the pharmaceutical or CRO
• Experience in pharmacovigilance preferably gained in a European environment (min 5 years) within drug safety department or QA;
• Exposure to at least 1 product submitted to Regulatory Authorities for marketing authorization in the EU
• Expert in the Safety Regulations and requirements relating to Pharmacovigilance in Europe
• Experience in Pharmacovigilance systems and Eudravigilance registrations
• Strong communicator with excellent English language skills, both written and spoken
• Self-confident, proactive and decisive
• Excellent communication skills, including formal presentation skills.
• Excellent organizational skills and ability to prioritize
• Experience in the area of audits/inspections