Regional Quality Manager – Switzerland

Mylene Paumier is recruiting for a Regional Quality Manager to join a leading pharmaceutical company at their offices in Switzerland on a permanent basis.

As an experienced CRA with expert knowledge of GCP/ICH rules, international and local regulations you will be expected to implement quality controls for your assigned regions that enhance monitoring procedures in accordance to regulations.

Click here to read the full job description and apply

 Regional Quality Manager - Switzerland  Regional Quality Manager - Switzerland

Posted in NewsTagged in , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

Global Pharmacovigilance Regional Head – London, Hertfordshire, South East

Hendre Moolman is recruiting for a Global Pharmacovigilance Regional Head to join a pharmaceutical company in a permanent r

ole in Hertfordshire.

 

As a Global Pharmacovigilance Regional Head the main purpose of your role you will be to manage Pharmacovigilance / Safety and Medical Information projects in regions (Asia Pacific, Americas, Europe, Middle East and Africa) where the company has a presence, providing medical expertise for Medical, Drug Safety/Pharmacovigilance and other corporate functions.

 

 

Responsibilities:

Further responsibilities of this Global Pharmacovigilance Regional Head position will include:

  • Establish Pharmacovigilance function in countries of the applicable Regions.
  • Train & support the Local Pharmacovigilance Responsible Person for specific region to perform Pharmacovigilance activities in their respective countries
  • Ensure the process set forth by Global Pharmacovigilance including ICSR(s), Aggregate Reports PSUR, DSUR) are written & reported to respective regulators with maintaining the highest level of compliance
  • Perform Pharmacovigilance review of protocols, CSR’s, PSUR’s, PADER’s, DSUR’s
  • Establish, support & facilitate routine Pharmacovigilance activities such as case processing, aggregate report, and signal detection
  • Oversee & perform routine quality checks on the activities that are outsourced to third party vendors on behalf of the company’s Pharmacovigilance function in countries of the applicable regions.
  • Train & support the Local Pharmacovigilance Responsible Person for specific region to perform PV activities in their respective countries able Pharmacovigilance
  • Settings, appraisal and management of direct line reports
  • Support internal & external inspections and audits from regulators & third party vendors
  • Support Global Head of Pharmacovigilance with process, structure, budgets and strategy decisions
  • Support function of the QPPV in Europe
  • Ensure the compliance of Global Pharmacovigilance system by working collaboratively with internal & external company personal

 

 

Qualifications, Skills and Experience:

As Global Pharmacovigilance Regional Head you will have the following qualifications, skills and experience

  • Graduate/post graduate in pharmacy/medicine/life science with very strong experience in pharmacovigilance
  • Direct PV experience or previous experience of clinical research is necessary
  • Expertise in a particular medical area preferred
  • Experienced in and knowledgeable about clinical development processes
  • Knowledge of regional drug authority regulations, GCP, ICH
  • Proven ability with high level influencing and negotiation skills
  • Excellent communicator with ability to educate and influence decisions through clear written and verbal communications
  • Strong organisational skills and detail oriented
  • Self-motivator
  • Dedication to quality in all work tasks and deliverables

As Global Pharmacovigilance Regional Head you will be joining a global pharmaceutical company based in Hertfordshire on a permanent role. This exciting opportunity offers a competitive salary and the opportunity to build on management experience.

 

 

 

Apply Now:

Hendre Moolman - Pharmacovigilance Recruitment at CK Clinical

Contact Hendre for more details.

Click here to apply online now >

 

For more information or to apply for this Global Pharmacovigilance Regional Head position please contact Hendre Moolman on +44 (0)1438 842 970 or email hmoolman@ckclinical.co.uk. Please quote reference CL25286 in all correspondence.

 

 

Not quite what you’re looking for?

Click here to search our current pharmacovigilance positions online now.

 

Global Pharmacovigilance Regional Head - London, Hertfordshire, South East   Global Pharmacovigilance Regional Head - London, Hertfordshire, South East   Global Pharmacovigilance Regional Head - London, Hertfordshire, South East   Global Pharmacovigilance Regional Head - London, Hertfordshire, South East

Posted in Featured Jobs, NewsTagged in , , , , , , , , , , , , , , , ,

Medical Writing Manager – Berkshire

Hendre Moolman at CK Clinical is recruiting for a Medical Writing Manager to join an established pharmaceutical company based in Berkshire.

The Job:

This Medical Writing Manager role offers a unique opportunity to have involvement with a broad range of medical writing documents study reports, investigator brochures, module II documents, and documents that take an overview of study documents (not just the compound/CMC).  This position will support global and regional submissions. This is a customer facing role as part of an internal service provision.

Responsibilities:

The key responsibilities for this Medical Writing Manager role are the following:

  • Ensure that all medical writing documents prepared for assigned Clinical Research Programmes within the company’s R&D are prepared according to appropriately rigorous, objective and informative medical writing procedures and processes.
  • Lead the Medical Writing activities for US, European or other regulatory submissions as assigned.
  • Ensure documents for assigned clinical trials are prepared, reviewed, and approved in a quality, timely and accurate manner such that the date presented will withstand examination by regulatory bodies.
  • Support the full use of the Electronic Document Management System (EDMS), for all clinical documents intended for submission, within the company.
  • Plan, schedule and track all assigned medical writing activities in close cooperation with the GPLs to ensure high quality, timely, and accurate completion of all documents at each point in the document lifecycle, and to provide monthly status reports and forecasts to the HMW.
  • Take responsibility for supervision/production, review, publishing, and finalization of assigned study reports.
  • Work with the HMW and MWM (IBs) for strategic planning, production & review of assigned summary documents.
  • Provide disease area guidance to internal and external writers for assigned projects
  • Take responsibility for ensuring that assigned medical writing deliverables meet the project specifications, and that they are produced within the timelines to defined quality, and content standards.
  • Supervise assigned medical writing projects contracted to third party suppliers, including interim and final integrated study reports and, where appropriate, integrated clinical summaries, protocols or other documents.
  • Take responsibility for ensuring that outsourcing of assigned medical writing projects is conducted after a thorough evaluation of the capabilities of the CRO/freelancer concerned, that the deliverables meet the project specifications, and that they are produced within the timelines to defined quality, and content standards.
  • Undertake assigned medical writing projects within including interim and final integrated study reports and where appropriate, integrated clinical summaries, protocols or other documents.
  • Ensure that assigned protocols, clinical study reports and investigator brochures and other documents as appropriate, are developed with medical writing input as early as possible.
  • Take responsibility as a medical writing adviser to project teams across assigned disease areas.
  • Work with the publishers to ensure quality, timely and accurate deliverables at each stage of the document lifecycle, to contribute to and to supervise accurate and timely publishing within EDMS.
  • Develop awareness of the benefits of the EDMS in the preparation of clinical documents.
  • Interact with other groups in order to provide an efficient, effective and timely medical writing service. Groups will include Clinical Development Teams, Study Teams and other groups as appropriate.
  • Keep abreast of current issues and developments in medical writing, particularly those impaction the neurology disease area.
  • Perform any other activity as may reasonably be required from time to time.
  • Complete all of the above activities within the framework and in compliance with ICH Guidelines, R&D SOPs and other documentation in force within the company.

Benefits:

Successful candidate for this Medical Writing Manager role will enjoy the benefits of working with a global Pharmaceutical company, including a competitive salary.

Qualifications:

The ideal candidate for this Medical Writing Manager role will have the following qualificaitions and

  • Life Science Degree, preferably with a higher degree (MSc or PhD) or other relevant qualifications
  • Good understanding of GCP, coupled with prior experience in clinical/preclinical pharmaceutical research and development.
  • Good understanding of the clinical development process and of ICH guidelines
  • Significant experience of working on summary level documents such as the Common Technical Document or Investigator’s Brochures.

How to apply:

Apply online:

For more information or to apply for this Medical Writing Manager job please contract Hendre Moolman on 01438 743 047 or email hmoolman@ckclinical.co.uk. Please quote reference CL24065 in all correspondence.

Are you looking for a pharmaceutical role in the UK and Europe? Click here to see our latest pharmaceutical jobs in the UK and Europe

Posted in Featured Jobs, NewsTagged in , , , , , , , , , , , , , , , , ,

Clinical Imaging Associate Job in Uxbridge

Russell Oakley at CK Clinical is currently recruiting for a Clinical Imaging Associate to join a global drug research and development company based in Uxbridge.

 

As Clinical Imaging Associate you will:

  • Conduct set-up of clinical trials within the internal imaging system under limited supervision
  • Proactively participates in a partnership with the matrix partners
  • Ensure trials are validated before going live
  • Understand financial drivers and their role in decision making
  • Ensures that the conduct of imaging work meets GCP requirements
  • Conduct image review against basic parameters (QC)
  • Raise queries using eDC system or alternative
  • Interact with wider stakeholders, e.g. CROs/vendors (Image Transfer CROs) and monitors.
  • Proactively track timelines and identify issues in order to propose strategies to implement

contingencies and risk planning to meet overall study/program goals.

  • Input into study plans and process documents.
  • Forecast and monitor data volumes within studies and/or across programs
  • Conduct end-of-study learning debriefs for study team
  • Provide input into process improvement initiatives.
  • Identify and disseminate best practices and standardization
  • Assure the quality of the deliverables.
  • Facilitate effective communication and teamwork

 

To be considered for this Clinical Imaging Associate position, you will have:

  • A Bachelors degree or equivalent, major course of study in Science or Health-related preferred
  • 2 years experience in clinical research
  • Strong computer literacy
  • Awareness of GCP and its application to clinical trials
  • Interpersonal skills associated with working in a matrix team
  • Solid understanding of clinical practices.  Understands impact of changes and is able to apply

changes to study design and potentially program level decisions.

How to apply:

Click here to apply online now.

For more information regarding this Clinical Imaging Associate position, please contact Russell Oakley at CK Clinical on +44 (0) 114 283 9956 or email roakley@ckscience.co.uk. Please quote reference CL24004 in all correspondence.

Looking for a new clinical job in the UK? Click here to search our current clinical jobs online now.

Posted in Featured Jobs, NewsTagged in , , , , , , , , , , , ,

Senior Clinical Compliance Specialist Job in London

Jim Gleeson at CK Clinical is recruiting for a Senior Clinical Compliance Specialist to join an international pharmaceutical company at their site based in London. This is a one year contract position.

As Senior Clinical Compliance Specialist you will ensure that European clinical trial activities are fully compliant with all internal and external regulations. This will cover the company’s own work and that of external vendors, managing technically complex audits and defining and communicating compliance risks.

 

As Senior Clinical Compliance Specialist you will have the following qualifications skills and experience:

  • Very extensive Clinical Quality Assurance experience, including hosting regulatory authority inspections
  • In depth knowledge of GxP regulation, ICH guidelines and FDA GCP requirements
  • Excellent understanding of the clinical trial and auditing processes
  • Ability to travel internationally, up to 40%

How to apply:

Click here to apply online now.

To find out more, please contact Jim Gleeson on 01438 870027 or email jgleeson@ckclinical.co.uk. Please quote reference CL23127 in all correspondence.

 

Click here to search our other Clinical jobs in London now.

Posted in Featured Jobs, NewsTagged in , , , , , , , , , , ,

Director of Clinical & Pharmacovigilance Job London

Jim Gleeson at CK Clinical is currently recruiting for an Associate Director of Clinical and Pharmacovigilance QA to join a global pharmaceutical company at their EU Headquarters based in London.

The role:

As Associate Director of Clinical and Pharmacovigilance QA, you will provide overall leadership for all EU QA activities within Clinical Development and Pharmacovigilance. In liaison with the global QA team your remit will be to ensure that these activities are fully compliant with ICH-GCP regulations and company policies and procedures.

Further responsibilities will include:

  • Act as the key QA representative for competent authority inspections for clinical trials and pharmacovigilance
  • Ensure that investigator, vendor, facility and system audits are carried out, that critical compliance risks are communicated to senior management and the corrective actions are implemented
  • Provide EU regional input to global quality initiatives
  • Identify and mitigate quality and compliance risks
  • Manage the EU aspects of the clinical audit and corrective action tracking database

 

 

The ideal candidate:

To be considered for this Associate Director of Clinical and Pharmacovigilance QA Job in London you will have the following skills, qualifications and experience:

  • Extensive and broad QA experience gained as either a client or vendor
  • Experience of study design, set up and conduct as well as of audits of all types
  • In depth knowledge of GxP regulations, EU regulations, FDA Good Clinical Practice and ICH guidelines
  • An understanding of Computer System Validation
  • Proven line management skills

 

How to apply:

For more information, or to apply for this Associate Director of Clinical and Pharmacovigilance QA please contact Jim Gleeson at CK Clinical on 01438 870027 or email jgleeson@ckclinical.co.uk. Please quote reference CL23220 in all correspondence.

Not quite what you’re looking for? Click here to search our current clinical jobs in London now.

Posted in company newsTagged in , , , , , , , , , , ,

Senior Clinical Compliance Specialist Job in London

Jim Gleeson at CK Clinical is currently recruiting for a Senior Clinical Compliance Specialist to join a major international pharmaceutical company at their London offices. This is a one year contract position.

The role:

As Senior Clinical Compliance Specialist, you will ensure that European clinical trial activities are fully compliant with all internal and external regulations. This will over the company’s own work and that of external vendors, managing technically complex audits and defining and communicating compliance risks.

Requirements:

To be considered for this Senior Clinical Compliance Specialist position, you will have the following skills, experience and qualifications:

  • Very extensive Clinical Quality Assurance experience, including hosting regulatory authority inspections
  • In depth knowledge of GxP regulation, ICH guidelines and FDA GCP requirements
  • Excellent understanding of the clinical trial and auditing processes
  • Ability to travel internationally, up to 40%

 

How to apply:

For more information or to apply for this Senior Clinical Compliance Specialist position please contact Jim Gleeson on 01438 870027 or email your CV to jgleeson@ckclinical.co.uk. Please quote reference CL23127 in all correspondence.

Not quite what you’re looking for? Click here to search our current clinical jobs now.

Posted in Featured Jobs, NewsTagged in , , , , , , , ,

Pharmacovigilance Audit Lead Job in Surrey

Hendre Moolman at CK Clinical is currently recruiting for a Pharmacovigilance Audit Lead to join an established biopharmaceutical company in Surrey.

The role:

As Pharmacovigilance Audit Lead, you will implement the QA risk-based audit programme and lead independent global pharmacovigilance audits. You will have the opportunity to perform audit metrics and root-cause analyses of non-compliances and provide guidance, train and support business partners. You will review and advise on pharmacovigilance related policies, Standard Operating Procedures and Internal Procedures.

Key responsibilities

  • Manage the strategic development of an effective global risk-based audit strategy and programme; collect, collate and incorporate input into audit strategy and plan.
  • Lead, plan, perform, conduct, follow-up and document global quality regulatory compliance audits and assessments of pharmacovigilance and safety reporting practices within the company.
  • Perform activities with a high degree of independence. Provide technical guidance, leadership, coaching and training of other auditors on audit related activities.
  • Review, evaluate and approve proposed corrective and preventive action plans (CAPA) in collaboration with the responsible business unit. Perform timely management of audit metrics and root cause analysis of non-compliances.
  • Monitor and track status of corrective and preventive actions to ensure that the issues are adequately addressed and completed.
  • Provide leadership to drive closure of audits through close collaboration with auditees, involved business units and partners.
  • Prepare routine over-view of outstanding CAPA (Corrective Action Preventive Action) items.
  • Identify and communicate quality and regulatory compliance issues to DS&E QA management and DS&E management through appropriate channels. Lead heavyweight initiatives geared towards remediation of compliance concerns; determine effectiveness of remediation activities; and provide on-going project support and governance, as assigned.
  • Prepare for, facilitate and lead logistics for local and global Health Authority (HA) PV inspections; assess results of pre-inspection preparation activities and HA inspection findings in terms of associated risks and communicate to management; provide input to CAPA to ensure quality, consistency and appropriateness of commitments.
  • Interface and communicate with regulatory authority representatives as required.
  • With a high degree of independence, evaluate audit and assessment results, identify specific regulatory, compliance and quality assurance training needs for global business partners and lead initiatives to develop, implement and conduct appropriate training.
  • Utilise professional competence to support DS&E with compliance investigations and initiatives focused on inspection readiness and quality, process and compliance improvement.
  • Analyse root causes for non-compliance through process review.
  • Identify issues and recommend conduct of formal investigations; sign-off investigations.
  • Review, advise and approve relevant local and global guidelines, policies, Internal Procedures and SOPs.
  • Proactively research local and global initiatives, trends and events that impact maintenance of compliance.

 

The ideal candidate:

Hendre is looking for candidates with the following skills, experience and qualifications:

  • Proven PV/clinical/industry/health authority experience with GCP/PV auditing experience;
  • Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision;
  • Ability to address a variety of tasks within the same timeframe while maintaining oversight; ability to maintain a high degree of independence with respect to decision making and problem solving;
  • Extensive experience with Health Authority inspections and interaction;
  • Excellent quality and compliance leadership and facilitation skills;
  • Excellent computer skills, including Excel, Word;
  • Extensive knowledge of applicable PV, GCP and GxP regulations, guidelines, policies and procedures;
  • Good knowledge of computer validation and Part 11 requirements;

 

How to apply:

For more information or to apply for this Pharmacovigilance Audit Lead, please contact Hendre on 01438 870 023 or email hmoolman@ckclinical.co.uk. Please quote reference CL23007 in all correspondence.

Not quite what you’re looking for? Click here to search our current Pharmacovigilance jobs now.

Posted in Featured Jobs, NewsTagged in , , , , , , , , , , , , , , , , , , , , ,

Junior Medical Writer Job – Berkshire, UK

Krishna Pankhania at CK Clinical is recruiting for a Junior Medical Writer to join an established pharmaceutical company based in Berkshire, UK.

The role:

As Junior Medical Writer, you will provide on-going support to the Publishing group and will be required to ensure that all clinical documentation for assigned projects are located and sourced from the internal archive. In addition you will have responsibility for ensuring that clinical documents published are sourced, prepared, published, reviewed and approved in a quality, timely and accurate manner.

Key responsibilities:

  • Prepare tabulated summaries along with preparation of in-text tables or narratives for the Senior Medical Writers or Medical Writer.
  • Create of hyperlinks and bookmarks for the Clinical Publisher.
  • With appropriate supervision, to undertake publishing tasks as required.
  • Carry out numeric Quality Control of documents as required under the supervision of the Lead Medical Writer.
  • Plan schedule and track all assigned oncology medical writing activities to ensure high quality, timely and accurate completion.
  • Provide regular status updates to the Lead Medical Writer for all assigned Oncology medical writing activities.
  • Under supervision write low complexity CSR.
  • Compile current study reports within the EDMS environment
  • Requesting required documents from the project manager, or other departments as appropriate
  • Checking documents for compliance with EDMS requirements
  • Entering documents into the EDMS structure
  • Interact and effectively communicate with other groups in order to source clinical documents as required by the Medical Writing Group.
  • Provide the necessary documents (protocols, clinical study reports) in Adobe PDF format
  • Scanning or converting clinical documents to Adobe Acrobat, with appropriate page formats, bookmarks and hyperlinks
  • Assessing documents for completeness and quality
  • Produce documents using other software packages as required.
  • With appropriate supervision, to undertake publishing tasks as required.
  • Perform any other activity as may reasonably be required from time to time.
  • Complete all of the above activities within the framework and in compliance with ICH Guidelines, R&D SOPs and other documentation in force within the company

 

The ideal candidate:

To be considered for this position, you will have the following skills and qualifications:

  • Life Science Degree or Numerate Degree
  • An understanding of the Clinical Development process & of ICH guidelines
  • Well-developed communication, presentation, analytical and interpersonal skills

 

 

How to apply:

For more information or to apply, please contact Krishna Pankhania at CK Clinical on 01438 743 047 or email kpankhania@ckclinical.co.uk. Please quote reference CL22494 in all correspondence.

Click here to apply online now!

 

Posted in Featured Jobs, NewsTagged in , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

Associate Director of Global QA– Home Counties

An Associate Director of Global QA is sought to work from the UK office of a very successful global pharmaceutical company based in the Home Counties.

Responsibilities:

You will have responsibility for the implementation and delivery of audit programs covering GCP, PV and IT, working at both global and local affiliate levels. A key aspect of this role will be personnel management and development, you will manage a team of up to eight auditors.

Requirements:

  • A thorough knowledge of national and international regulations pertaining to GCP, Pharmacovigilance and IT compliance regulations
  • Extensive experience gained within pharmaceutical compliance
  • Proven line management skills, able to train, supervise and develop staff
  • Willingness to travel nationally and internationally, up to 30%

 

How to apply

For more information or to apply for this Associate Director position, please contact Jim Gleeson at CK Clinical on 01438 743 047 or email jgleeson@ckclinical.co.uk. Please quote reference CL21767 in all correspondence.

Posted in Featured JobsTagged in , , , , , , , , , , ,