Head of QPPV Office and PV Intelligence
7 months ago
For our GSPV department, we are looking for a
Head of QPPV Office and PV Intelligence (m/f/x)
R-233736
Fulltime / permanent / non-tariff
The Opportunity
As Head of QPPV Office and PV Intelligence you will be responsible for the direction and management of the QPPV office team and the PV Intelligence function to ensure accurate descriptions are in place of CSL’s Pharmacovigilance system (the EU-Pharmacovigilance System Master File (PSMF)) and at national levels in compliance with applicable legislative requirements. In addition, the role oversees applicable PV regulations globally, leads the impact assessment of new/revised PV legislation on existing safety processes and is responsible for end-to-end oversight of such changes to the QPPV to support compliance of the GSPV function at a global level
The Role
Your main responsibility in this role will be to maintain and further develop the EU-PSMF as required in EU legislation as well as the UK PSMF as required in the UK legislation You will oversee content of local PSMFs/Pharmacovigilance Sub-System Files (PSSFs) and ensure alignment with the EU-PSMF Another focus for you will be to ensure compliance of CSL’s PV system with changes in the global regulatory environment by leading an end-to-end process for legislative changes related to PV including impact assessments and functional implementation of process changes where required You will lead and develop a team of Pharmacovigilance professionals in line with departmental and company objectives and will act as SME during Health Authority inspections and support inspection readinessYour Skills and Experience
Master’s degree in sciences (e.g., Medicine, Pharmacy, etc.) 10+ years Pharmacovigilance experience in multinational pharmaceutical industry SME of PSMF/local PSMF/PSSF and applicable legislation/guidelines Broad understanding of the global PV system, its quality system, and the dependencies of PV activities across the company Expert knowledge of international standards and regulatory requirements/ regulations and processes related to pharmacovigilance including GCP related Pharmacovigilance Experience in project-management, CAPA and SOP development Experience in people managementWhat we offer
Innovative work-environment at our CSL-subsidized company bike leasing Childcare “Kita Froschkönig” for up to 14 children (from 6 months till 3 years old) Access to Gym facility on campus 2 Wellness days per year (additional paid time off) Family services such as psychological support, legal advisory, family care services and more for you and your direct family-
Regional Safety Officer
3 weeks ago
Maidenhead, United Kingdom Csl Vifor Full timeThe primary objective of the United Kingdom and Ireland (UK/IE) Regional Safety Officer (RSO) position is to manage the local pharmacovigilance (PV) system within CSL Vifor UK and Ireland, ensuring compliance with applicable PV regulations and guidelines as well as corporate and Global Safety & Pharmacovigilance (GSPV) policies.This position provides expert...
-
Commercial Safety Officer
4 weeks ago
Maidenhead, Windsor and Maidenhead, United Kingdom CSL Behring Full timeJob DescriptionIn this role, you will be responsible for managing the local pharmacovigilance system within CSL Vifor UK and Ireland, ensuring compliance with applicable regulations and guidelines.The primary objective of this position is to provide expert input on pharmacovigilance-related matters and develop strategies to ensure seamless completion of PV...
-
Regulatory Intelligence Coordinator
3 days ago
Maidenhead, Windsor and Maidenhead, United Kingdom Randstad Sourceright Full timeKey ResponsibilitiesSupports the Organised Data Collection Programs (ODCPs) process for AE collection to ensure consistency with regulations and with departmental goals and objectives.Supports the collection, analysis, communication, and operational change management process for Regulatory Intelligence related to PV in the Distributor Network.Delivers...
-
Regulatory Affairs Officer
13 hours ago
Maidenhead, United Kingdom Select Pharma Careers Full timeAn exciting opportunity has become available with my client, a growing pharmaceutical company, for an experienced and enthusiastic Regulatory Affairs professional wishing to expand their experience and knowledge in a growing Reg team.With a focus on post-approval activities, the successful candidate will gain exposure to many aspects of Regulatory compliance...
-
Pharmacovigilance Specialist
1 week ago
Maidenhead, United Kingdom Adepto Technical Recruitment Ltd Full timePharmacovigilance Specialist - Life Science - Contract - Remote, UK Our client is a global leading life science organisation. At present they are seeking a Pharmacovigilance Specialist on a 12 month contract basis. The role will be predominantly remote based with some travel to their site in West London (once or twice per month). The role: You will be is...
-
Pharmacovigilance Specialist
3 days ago
Maidenhead, United Kingdom Adepto Technical Recruitment Ltd Full timePharmacovigilance Specialist - Life Science - Contract - Remote, UKOur client is a global leading life science organisation. At present they are seeking a Pharmacovigilance Specialist on a 12 month contract basis. The role will be predominantly remote based with some travel to their site in West London (once or twice per month).The role:You will be is a core...
-
Pharmacovigilance Specialist
1 week ago
Maidenhead, United Kingdom CV-Library Full timePharmacovigilance Specialist - Life Science - Contract - Remote, UK Our client is a global leading life science organisation. At present they are seeking a Pharmacovigilance Specialist on a 12 month contract basis. The role will be predominantly remote based with some travel to their site in West London (once or twice per month). The role: You will be is...
-
Select Oh | Regulatory Affairs Manager
13 hours ago
Maidenhead, United Kingdom Select Oh Full timeAn exciting opportunity for an experienced Regulatory Affairs Manager to take on a new role in a growing generic pharmaceutical company working towards a portfolio of 220 licenses.Responsibilities: Primarily responsible for post-approval and compliance activities with a support role for the pre-approval team Have an excellent understanding of and be able to...
-
Operations Project Officer
6 months ago
Maidenhead, United Kingdom Evergen Solar Full time**Evergen Are Recruiting...** **What we doFeel Good energy!** Evergen have been pushing the agenda for solar and battery systems as a way to reduce energy costs for years. Our speciality is the installation of highly effective solar panel and battery systems tailored to our customers property and energy usage. Evergen are the proud winners of several...
-
Team Administrator
6 months ago
Maidenhead, United Kingdom Ultra Intelligence & Communications Full timeCompany: Ultra Intelligence & Communications Cyber OBU Provide Decision Advantage to Mission Partners Around the World Join us in our mission to provide the world's military members with the latest, most customizable solutions and capabilities, enabling mission success anywhere around the globe. At Ultra Intelligence and Communications (I&C), we provide...
-
Safety Associate II Professional
3 days ago
Maidenhead, Windsor and Maidenhead, United Kingdom Randstad Sourceright Full timeAbout the RoleWe are seeking a highly skilled and experienced Drug Safety Associate II to join our team in Maidenhead. The ideal candidate will have a strong background in pharmacovigilance and regulatory intelligence.The successful candidate will support the Global Case Management (GCM)/International Pharmacovigilance (IPV) group in performing daily...
-
Customer Administrator
6 months ago
Maidenhead, United Kingdom Haulfryn Head Office Full timeOur Haulfryn family has an exciting opportunity for a **Customer Administrator **to join our** **Support Office Team. The Customer Administrator will be responsible for the accurate administration and delivery of all owner related tasks including contract administration, bulk checks, mail shots and filing. **Why Join Us** - Competitive salary - Bonus...
-
Select Pharma | Regulatory Affairs Officer
13 hours ago
Maidenhead, United Kingdom Select Pharma Full timeAn exciting opportunity has become available with my client, a growing pharmaceutical company, for an experienced and enthusiastic Regulatory Affairs professional wishing to expand their experience and knowledge in a growing Reg team.With a focus on post-approval activities, the successful candidate will gain exposure to many aspects of Regulatory compliance...
-
Regulatory Affairs Associate
1 day ago
Maidenhead, United Kingdom Select Pharma Careers Full timeAn exciting new opportunity has arisen for a Regulatory Affairs Associate to join my client, a growing pharmaceutical company based in Berkshire. This role will suit a regulatory professional at the beginning of their career please note that 6 months to 1 year of regulatory experience is required.++ Please note that this role is fully office based (5 days...
-
Stock Administrator
6 months ago
Maidenhead, United Kingdom Haulfryn Head Office Full timeHaulfryn family has a fantastic opportunity for a Stock Administrator to join our Support Office who will be responsible for the accurate administration and delivery of all caravan stock duties from order to delivery, sales, aftersales and disposal of homes. We are one of the UK’s largest owners of 5-star luxury holiday and residential parks set in...
-
HR Administrator
6 months ago
Maidenhead, United Kingdom Haulfryn Head Office Full timeOur Haulfryn family has a fantastic opportunity for a part time (6-Month Fixed Term Contract) **HR Administrator (21 hours per week) **to join our growing team at our friendly support office in Maidenhead. The** **HR Administrator will deliver a proactive and flexible HR administration and support service to the overall team members' life cycle whilst...
-
Purchase Ledger Supervisor
6 months ago
Maidenhead, United Kingdom Haulfryn Head Office Full timeHaulfryn has a fantastic opportunity to join an established and successful Purchase Ledger Team in supporting our holiday and residential parks! If this sounds like your ideal role we'd love to hear from you. Hours: 35 hours per week (Monday to Friday 9:00am-5:00pm) Location: Support Office, Maidenhead, SL6 4FL **Job Type**: Permanent **The...
-
Pharmacovigilance Operations Coordinator
3 days ago
Maidenhead, Windsor and Maidenhead, United Kingdom Adepto Technical Recruitment Ltd Full timeOur client, a global leading life science organisation, is seeking a Pharmacovigilance Specialist for a 12 month contract basis. This role will be predominantly remote based with some travel to their site in West London (once or twice per month).The Role:You will be a core member of the Global Safety & Pharmacovigilance team. Your purpose will be to support...
-
Marketing Executive
6 months ago
Maidenhead, United Kingdom Haulfryn Head Office Full timeOur Haulfryn family has a fantastic opportunity for a full time **Marketing Executive **to join our growing team at our friendly support office in Maidenhead We are looking for a confident go-getter who is wanting to progress their career in marketing. This role will support the Web & Digital Manager and Marketing Manager to shape and develop marketing...
-
Safety Associate II
20 hours ago
Maidenhead, United Kingdom Randstad Sourceright Full timeAbout the RoleWe are seeking a skilled Safety Associate II - Pharmacovigilance to join our team in Maidenhead. The successful candidate will have experience of working with electronic learning management systems and knowledge of PV activities and processes.In this role, you will be responsible for supporting the Organised Data Collection Programs (ODCPs)...