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Pharmaceutical QC Manager
6 days ago
CSL Seqirus Maidenhead, Berkshire, United Kingdom Full timeThe Manager, Global Aggregate Reports Quality and Compliance is an integral member of the Global Aggregate Report office and PV Writing Organization. Acts as a Regulatory Intelligence Triage Manager, responsible for driving initial assessment of regulatory changes related to Safe ...
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Pharmaceutical QC Manager
4 days ago
CSL Seqirus Maidenhead, Berkshire, United KingdomThe Manager, Global Aggregate Reports Quality and Compliance is an integral member of the Global Aggregate Report office and PV Writing Organization. Acts as a Regulatory Intelligence Triage Manager, responsible for driving initial assessment of regulatory changes related to Safe ...
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Pharmaceutical Business Development Manager
1 week ago
Evolve Selection Ltd St. Albans, United KingdomA brand-new fantastic opportunity as a Pharmaceutical Business Development Manager to work with a global leading European research-based pharmaceutical organisation Our client is in search for a hardworking and proactive individual to join their team. Thisis a full time hybrid po ...
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Pharmaceutical Production Manager
2 days ago
RBW Consulting Guildford, United KingdomJob Description · Pharmaceutical Production Manager · Location: Guildford · An exciting career advancement awaits you in the dynamic pharmaceutical industry. You'll spearhead cutting-edge radiopharmaceutical production, directly impacting the delivery of top-notch patient care. ...
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Pharmaceutical QC Manager
2 days ago
CSL Seqirus Berkshire, United KingdomThe Manager, Global Aggregate Reports Quality and Compliance is an integral member of the Global Aggregate Report office and PV Writing Organization. Acts as a Regulatory Intelligence Triage Manager, responsible for driving initial assessment of regulatory changes related to Safe ...
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Pharmaceutical Project Manager
1 day ago
The Square Foundation London, United Kingdom Permanent, Full timeAre you looking for a flexible role in the pharmaceuticals sector? Would you like to make a real difference in a charity supporting health care in sub–Saharan Africa through pharmacy education? The Square Foundation has a fantastic opportunity for a Pharmaceuticals Project Manage ...
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Pharmaceutical Brand Manager
6 days ago
UKPHARM LIMITED Greater London, United KingdomJob Description · Brand Manager - Pharmaceutical - London -strong salary, bonus, car allowance · One of the quickest growing companies in one of the most dynamic markets at present in the UK. · This role will manage the full marketing cycle. Ideally, you will be able to demonstra ...
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Pharmaceutical Sales Manager
2 weeks ago
Evolve Selection London, United KingdomJoin a Renowned Pharmaceutical Organisation · Evolve is thrilled to announce an exciting opportunity with a leading pharmaceutical organisation. We are recruiting for an experienced NHS Sales Manager to join their esteemed team. As the NHS Sales Manager, you will play a pivotal r ...
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Pharmaceutical Brand Manager
1 week ago
PE Global International Basingstoke & Deane, Hampshire, United KingdomPE Global is recruiting a pharmaceutical brand manager for our multinational pharmaceutical client on an initial 12-month contract basis in Basingstoke. The role is hybrid. · Responsibilities of the role: · Brand Strategy Development and Management across UK and RoI · Ensure exec ...
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QC Manager, Pharmaceutical
2 weeks ago
RBW Consulting Epsom, Surrey, United KingdomI am partnered exclusively with an international advanced pharmaceutical company that are growing key leadership and management positions across UK sites. · This specific hire will take management and scheduling responsibilities for all site Quality Control (QC) activities with ...
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QC Manager, Pharmaceutical
1 week ago
In Sutton London, United KingdomI am partnered exclusively with an internationaladvanced pharmaceutical company that are growing key leadership andmanagement positions across UK sites. · Thisspecific hire will take management and scheduling responsibilities forall site Quality Control (QC) activities with stro ...
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QC Manager, Pharmaceutical
5 days ago
Hobson Prior London, United KingdomHobson Prior is seeking a Senior QC Manager Analytics for a permanent role based in London. The successful candidate will be responsible for overseeing the Quality Control department, ensuring the laboratory is always ready for inspection and that all data generated is compliant ...
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Purchasing Manager Pharmaceuticals
2 weeks ago
McAllister Recruitment & Consultancy London, United KingdomJob description · We looking to recruit an experienced Purchasing Manager who will lead the procurement department to optimise the overall purchasing performance for the business, with a specific remit on supply from designated EU countries and worldwide. He/she will lead the Pha ...
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QC Manager, Pharmaceutical
1 week ago
Hobson Prior London, United KingdomHobson Prior is seeking a Senior QC Manager Analytics for a permanent role based in London. The successful candidate will be responsible for overseeing the Quality Control department, ensuring the laboratory is always ready for inspection and that all data generated is compliant ...
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Purchasing Manager Pharmaceuticals
1 week ago
McAllister Recruitment & Consultancy London, United KingdomJob description · We looking to recruit an experienced Purchasing Manager who will lead the procurement department to optimise the overall purchasing performance for the business, with a specific remit on supply from designated EU countries and worldwide. He/she will lead the P ...
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QC Manager, Pharmaceutical
1 week ago
Hobson Prior London, United KingdomJob Description Hobson Prior is seeking a Senior QC Manager Analytics for a permanent role based in London. The successful candidate will be responsible for overseeing the Quality Control department, ensuring the laboratory is always ready for inspection and that all data generat ...
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Business Manager, Pharmaceutical
1 day ago
Pharmiweb London, United KingdomBusiness Manager - Medical Devices - Dialysis. Exciting new opportunity working across the Greater London area Role: Business Manager · Therapy Area: Medical Devices - Dialysis · Salary: Competitive salary, company car, bonus, and additional benefits package · Medical Represen ...
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Pharmaceutical Brand Manager
4 days ago
UKPHARM LIMITED London, United KingdomBrand Manager - Pharmaceutical - London -strong salary, bonus, car allowance · One of the quickest growing companies in one of the most dynamic markets at present in the UK. · This role will manage the full marketing cycle. Ideally, you will be able to demonstrate good experien ...
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Business Manager, Pharmaceutical
3 days ago
Chemistree Solutions London, United KingdomBusiness Manager - Medical Devices - Dialysis · Employer Chemistree Solutions Location Greater London - within the M25 Salary Competitive salary, car, bonus and additional benefits package Start date 8 May 2024 Closing date 7 Jun 2024 · Business Manager - Medical Devices - Dial ...
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Pharmaceutical Project Manager
1 day ago
Barrington James Limited London, United KingdomClient specialises in deploying Business Solutions utilizing Enterprise Content Services platforms within the Life Sciences sector. With a growing reputation as a trusted vendor and partner, we cater to a diverse clientele ranging from emerging startups to global pharmaceutical g ...
Pharmaceutical QC Manager - Maidenhead, Berkshire, United Kingdom - Cockenzieandportseton
Description
The Manager, Global Aggregate Reports Quality and Compliance is an integral member of the Global Aggregate Report office and PV Writing Organization.
Acts as a Regulatory Intelligence Triage Manager, responsible for driving initial assessment of regulatory changes related to Safety Sciences in alignment with functional Leads (e.g., Coordinates the Aggregate Reports Quality Review Board and overseeing Aggregate report KPIs across CSL business units.The authoring of high quality regulatory required aggregate reports including scientific analysis and presentation of safety data which is a key contribution for successful product registrations.
Acts as a Regulatory Intelligence Triage Manager, responsible for driving initial assessment of regulatory changes related to Safety Sciences in alignment with functional Leads (e.g., Coordinates the Aggregate Reports Quality Review Board and overseeing Aggregate report KPIs across CSL business units.Acts as a Triage Manager, performs impact assessments of evolving pharmacovigilance legislation and regulatory guidance in safety sciences, e.g.
, aggregate reporting, literature review, signal detection / signal management (GRIP Process), assign to different functional representatives based on the impact within GRIP process and if required, seek input from functions outside of safety sciencesReviews and communicates all regulatory changes that may have an impact on areas within safety sciences to all relevant stakeholders for further implementation, if required
Provides status of implementation of regulatory changes to Head of safety sciences and Team Leads in safety sciences following alignment with functional SMEs.
Collaborate with relevant QPPV function within GCSP for further coordination of input to upcoming regulatory changes through Health Authority Consultation Reviews within safety sciences.
Acts as a SME for quality and regulatory compliance for Aggregate reports.Support on Aggregate Reporting Quality Review Board meeting: oversee HA responses to CSL aggregate reports, ensure compliance with HA commitments in the area of aggregate reporting, adapt processes to HA requirements to continuously ensure CSL aggregate reports of highest quality, supporting smooth product registration in all countries where CSL markets its products., including organization and running of Quality Review Board Meetings, definition of KPIs and proposal of measure for continuous improvement of the quality of CSL Aggregate Reports based on Health Authority feedback.
Acts as a SME for Quality oversight in preparation and conduct of audit and inspection, including interviewee and CAPA management.
Support inspection readiness of Global Aggregate Report office and PV Writing function.Acts as subject matter expert for audits and Health Authority inspections and in case of findings, performs root cause analysis and management of CAPA for Global Aggregate report office.
Support developing, maintaining, and overseeing the key performance indicators for vendors based on the governance documents.Quality Review of aggregate reports to ensure consistent high quality of CSL aggregate reports across the entire portfolio.
Acts as a vendor management contact back-up.
CSS, GPRO, Regulatory, L-QPPV/SO)
May act as PV Trainer for service providers in Global Aggregate Report office
Interface Management
Case Management, Regions and SO / L-QPPV network, CSS & GSL, GRA, Medical Affairs, Commercial Development, Clinical Development
Integrations Support Integrations of Global Aggregate Report office and PV Writing function processes, templates, and principles, e.g., University Degree (Diploma or MSc) in a life science (e.g.
, MD, PharmD, biology, nursing, nutrition), Quality, Medical Records management, or related area with relevant experienceMore than five (5) years of relevant pharmaceutical / biotechnology industry experience, of which at least four (3) should be in a Pharmacovigilance role, ideally in safety sciences and related to aggregate reporting and PV writing and/or vendor management and PV quality.
Experience in writing and QC of GxP relevant documents (technical writing, medical writing)A comprehensive understanding of pharmacovigilance, clinical development, and post-marketing safety requirements, including the regulatory safety documents required at each stage.
Experience in CAPA management as well as writing of SOPs and maintenance of templates.Experience in working with relevant software applications (Office, SharePoint, Databases)
Experienced in regard to GxP Training and Training Systems.
We want Seqirus to reflect the world around us As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion.
Learn more about Diversity & Inclusion at CSL Seqirus.Watch our 'On the Front Line' video to learn more about CSL Seqirus
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