Meet up with Hendre at MSLA today

Hendre Moolman is attending the Third Annual MSLA Conference today at the Park Inn Heathrow at Heathrow airport. The theme of the conference is “MSLs Sharing and Learning Together”

The conference is intended to be a stimulating mix of keynote speakers, panel sessions, interactive workshops and plenty of time for networking. The topics presented will be of interest to all MSLs irrespective of Company, experience and therapy interests.

Hendre will be at the event all day today so if you would like to meet up with him contact him here

 

Find out more about the event here

 

 

 

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Clinical Jobs of the Week: 26/06/2014

Here our latest clinical jobs in this week 26/06/2014:

 

Clinical 

Clinical Development Scientist – Middlesex

Clinical Study Manager – Surrey

Clinical Operations Expert Support – Basel

 

Regulatory Affairs:

Principle Regulatory Officer – Home counties

Program Leader – South West London

 

Biometrics:

Global Data Manager – Belgium

Principal Programmer – London

Clinical Data Manager – London

Clinical Programmer – South East

 

PV & Medical Affairs:

Medical Information Manager – South East

Medical Science Liaison (Mat Cover) – Home & field based

Safety Surveillance Associate – Kent

Pharmacovigilance Officer – Middlesex

 

Market Access/Clinical Supplies

Strategic Pricing Specialist, Field Based

Clinical Supplies Senior Planner, West London

 

 

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CK Clinical launches new mobile website

CK Clinical has launched a dynamic new mobile website which provides the ultimate job-hunting-on-the-move experience. With functionality that enables users to search for jobs through their mobile devices, watch our best videos and find the right consultant for you.

Registered CK+ members are even able to log in and apply for jobs through the interactive new mobile site.

So make sure you sign up for CK+ today.

The new CK Clinical mobile website offers a great user experience for everyone. Keep your eyes open for further developments on our CK Clinical website.

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CK Group a top SME in Derbyshire

CK Group is one of North Derbyshire’s top 50 SME’s according to research undertaken by Barber Harrison & Platt (BHP), a local chartered accountants. Contributing to an annual turnover of £633 million and the employment of nearly 4300 people, CK Group is proud to have become a central part of the economic growth of the region.

With three regional offices across the UK, CK Group are the owners of three recruitment brands – CK Science, CK Clinical and CK IT which specialise in the recruitment of scientific, pharmaceutical and technical roles across the UK and Europe.

CK Group has big plans in place for 2014, including responding to global recruitment demands, establishing our position as a leader in workforce outsourcing solutions and launching a new, dedicated Engineering division.

For more information on CK Group click here

If you would like to discuss your recruitment with one of our dedicated consultants, click here

 

 

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Pharmacovigilance Directors – Home Counties

Jim Gleeson is recruiting for 3 Pharmacovigilance Directors for a contract role at the EU Head Quarters of a highly successful pharmaceutical company based in the Home Counties.

Duties will include leading the pharmacovigilance activities for products in clinical development, and on the market, within the areas of oncology, neurology or primary care.

The successful candidates will need to have a medical degree, as well as extensive pharmacovigilance experience.

Click here to read more and to apply

 

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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

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Pharmacovigilance and Medical Information Officer Job in Essex

Krishna Pankhania at CK Clinical is currently recruiting for a Pharmacovigilance and Medical Information Officer to join a successful pharmaceutical company based in Essex, UK.

 

The role:

As Pharmacovigilance and Medical Information Officer, you will part of a team providing an effective and proficient drug safety and drug information service to support the medical and commercial activities of the company.

Main responsibilities:

  • Triage and process Individual Case Safety Reports (ICSRs) to agreed internal and external timelines and procedures.
  • Provide timely, accurate and relevant medical / scientific information to internal and external customers, ensuring that the information provided is technically accurate and consistent with prescribing information.
  • Receive adverse event data and provide medical information on company products.
  • Enquiries may originate from healthcare professionals, members of the public and internal staff and be received via telephone, email, post or in person.
  • Weekly literature searches
  • Develop and maintain references for provision of information on the Company’s products.
  • Maintain Medical Information Database and Medical Information and Pharmacovigilance records.
  • Reviewing and approving Artwork components

 

The ideal candidate:

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

  • Life Sciences or Pharmacy degree or equivalent
  • Good written and oral communication skills
  • Good interpersonal and team working skills
  • Good IT skills including familiarity with Microsoft Office packages
  • Excellent attention to detail
  • Desirable
  • A minimum of one year’s experience in medical affairs, medicines information, or drug safety within the pharmaceutical industry or NHS
  • Possess up-to-date knowledge of medical information guidelines and pharmacovigilance regulations
  • Experience with pharmacovigilance and medicines information databases
  • Medical writing skills
  • Good time management skills
  • Familiarity with ABPI Code of Practice and copy review
  • Artwork review and approval

 

How to apply:

For more information or to apply for this Pharmacovigilance and Medical Information Officer position, please contact Krishna Pankhania at CK Clinical on 01438 870 023 or email kpankhania@ckclinical.co.uk. Please quote reference CL23093 in all correspondence.

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

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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.

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Jobs of the Week: Pharmacovigilance – Hertfordshire

Krishna Pankhania at CK Clinical is currently recruiting for two roles within Pharmacovigilance. To find out more, please watch her short video or take a look at the job descriptions below…

 

Compliance and Training Manager Job in Hertfordshire, UK

Krishna is currently recruiting for a Compliance and Training Manager to join a Pharmaceutical company based in Hertfordshire.

Managerial Responsibilities:

  • Responsible for line management of direct reports.
  • Works flexibly with colleagues to ensure PV deliverables can be met while ensuring compliance and quality.
  • Holds staff appraisals and 121 meetings and regularly reviews progress.
  • Responsible for the performance management of direct reports.
  • Works with direct reports to create training and development plans for staff and regularly reviews progress. Works with direct reports to develop objectives.
  • Responsible for recruitment and retention of staff within own team.
  • Responsible for escalation and resolution of issues (departmental, client, authority or other party)
  • Authorship, review and/or approval of both Pharmacovigilance Departmental and project specific SOPs, working instructions and other procedural documents.
  • Contributes to, approves and implements CAPAs arising from inspections, external audits and internal audits.
  • Ensures back ups are in place to ensure smooth running of the department at all times.
  • Identifies need for new resource and communicates business case to Director PV.

Compliance and Training Management Responsibilities:

  • Works closely with Quality Director in the development and maintenance of the QMS.
  • Ensures adequate quality and compliance oversight of the work of the submissions team. Including all aspects of Eudravigilance, compliance submission of ICSRs and Aggregate reports on behalf of Clients.
  • Develops and implements standards within PV.

Skills and Experience:

  • Life Science degree or similar experience gained in Pharmaceutical Industry.
  • Experience in compliance related role within in a clinical research including PV.
  • CAPA management and SOP development experience required.
  • Experience of setting up training systems desirable.
  • Understanding of CSV and knowledge of safety databases desirable.
  • Good knowledge of PV regulations EU and USA
  • Experience of line management required
  • Good leadership skills
  • Ability to work under pressure.
  • Proactive approach to work
  • Project Management skills and ability to structure plans and ensure implementation
  • Good Team worker
  • Good organisational skills
  • Strong communication skills both verbal and written.
  • Ability to negotiate and influence

 

Pharmacovigilance Manager Job in Hertfordshire

Krishna is also recruiting for a Pharmacovigilance Manager to join a Pharmaceutical company based in Hertfordshire.  As Pharmacovigilance Manager you will act as the direct report to a medium sized team. Responsibilities will include:

General Responsibilities:

  • Communication with clients, regulatory authorities, ethics committees, investigational sitesand reporters and other client service providers.
  • Ensure client and patient confidentiality is maintained.
  • Operating at all times according to the appropriate SOP/procedural document.
  • Prioritisation of activities to meet departmental, client and regulatory time-lines.
  • Escalation of any issues that may impact on quality or compliance to the Pharmacovigilance Management Group and/or Manager Director.
  • Maintaining awareness of current and potential guidelines/legislation on pharmacovigilance and related matters, clinical trial guidelines and other relevant topics.
  • Maintain an accurate record of expenditure on external services.
  • Maintain a time sheet to accurately record time spent on client and departmental projects.
  • Any other reasonable task as requested by the Pharmacovigilance Management Group or Managing Director.
  • To act as back up to other members of the Pharmacovigilance Management Team when required.

Managerial Responsibilities:

  • Responsible for line management of direct reports.
  • Responsible for ensuring efficient and effective appropriate use of departmental resources.
  • Assists in financial forecasting and managing project level budgets.
  • Responsible for ensuring contract deliverables are met for all projects managed by direct reports.
  • Acting as part of the PV Management group, to ensure all services undertaken by Pharmacovigilance Department are run in adherence with applicable legislation and to quality standards.
  • Proactive and structured management of the PV department workload to ensure regulatory compliance and quality standards are upheld.
  • Working flexibly with colleagues to ensure PV deliverables can be met.
  • Anticipates, plans and prioritises activities in support of meeting project deliverables.
  • Holding staff appraisals and 121 meetings.
  • Working with staff to create training and development plans and regularly reviewing progress.
  • Working with direct reports to develop objectives and regular review of progress.
  • Recruitment and retention of high quality staff.
  • Responsible for prompt escalation of issues and assists in resolution (personnel, resourcing, departmental, client, authority or other party).
  • Facilitates preparation and participation in internal audits and inspections.
  • Contributing to, approval and implementation of CAPAs arising from inspections, external audits and internal audits.
  • Assists in development and implementation of a training system across PV.
  • Ensures back ups are in place to ensure smooth running of the department at all times.
  • Identifies need for new resource and communicates business case to Director PV.
  • Is accountable for delegation of tasks.
  • Encourages efficiency and effectiveness in solutions.

Skills and Experience:

  • Life Science degree or similar experience gained in Pharmaceutical Industry.
  • Extensive experience in PV across ICSR management, aggregate report writing and inspection preparation and participation.
  • Good knowledge of PV regulations EU and USA.
  • Experience of line management required.
  • Good leadership skills.
  • Ability to work under pressure.
  • Proactive approach to work.
  • Project Management skills and ability to structure plans and ensure implementation.
  • Good Team worker.
  • Good organisational skills.
  • Strong communication skills both verbal and written.
  • Ability to negotiate and influence.

 

How to apply:

For more information, or to apply for either of these roles, please contact Krishna Pankhania at CK Clinical on 01438 743 047 or email kpankhania@ckclinical.co.uk.

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Pharmacovigilance Manager Job in Hertfordshire, UK

Krishna Pankhania at CK Clinical is currently recruiting for a Pharmacovigilance Manager to join a pharmaceutical company based in Hertfordshire, UK.

 

The role:

As Pharmacovigilance Manager, you will be part of a medium sized team and will act as the direct report to the team. Further responsibilities will include:

  • Communication with clients, regulatory authorities, ethics committees, investigational sitesand reporters and other client service providers.
  • Ensure client and patient confidentiality is maintained.
  • Operating at all times according to the appropriate SOP/procedural document.
  • Prioritisation of activities to meet departmental, client and regulatory time-lines.
  • Escalation of any issues that may impact on quality or compliance to the Pharmacovigilance Management Group and/or Manager Director.
  • Maintaining awareness of current and potential guidelines/legislation on pharmacovigilance and related matters, clinical trial guidelines and other relevant topics.
  • Maintain an accurate record of expenditure on external services. 
  • Maintain a time sheet to accurately record time spent on client and departmental projects.
  • Any other reasonable task as requested by the Pharmacovigilance Management Group or Managing Director.
  • To act as back up to other members of the Pharmacovigilance Management Team when required.
  • Responsible for line management of direct reports.
  • Responsible for ensuring efficient and effective appropriate use of departmental resources.
  • Assists in financial forecasting and managing project level budgets.
  • Responsible for ensuring contract deliverables are met for all projects managed by direct reports.
  • Acting as part of the PV Management group, to ensure all services undertaken by Pharmacovigilance Department are run in adherence with applicable legislation and to quality standards.
  • Proactive and structured management of the PV department workload to ensure regulatory compliance and quality standards are upheld.
  • Working flexibly with colleagues to ensure PV deliverables can be met.
  • Anticipates, plans and prioritises activities in support of meeting project deliverables.
  • Holding staff appraisals and 121 meetings.
  • Working with staff to create training and development plans and regularly reviewing progress.
  • Working with direct reports to develop objectives and regular review of progress.
  • Recruitment and retention of high quality staff.
  • Responsible for prompt escalation of issues and assists in resolution (personnel, resourcing, departmental, client, authority or other party).
  • Facilitates preparation and participation in internal audits and inspections.
  • Contributing to, approval and implementation of CAPAs arising from inspections, external audits and internal audits.
  • Assists in development and implementation of a training system across PV.
  • Ensures back ups are in place to ensure smooth running of the department at all times.
  • Identifies need for new resource and communicates business case to Director PV.
  • Is accountable for delegation of tasks.
  • Encourages efficiency and effectiveness in solutions.

 

The ideal candidate:

  • Life Science degree or similar experience gained in Pharmaceutical Industry.
  • Extensive experience in PV across ICSR management, aggregate report writing and inspection preparation and participation.
  • Good knowledge of PV regulations EU and USA.
  • Experience of line management required.
  • Good leadership skills.
  • Ability to work under pressure.
  • Proactive approach to work.
  • Project Management skills and ability to structure plans and ensure implementation.
  • Good Team worker.
  • Good organisational skills.
  • Strong communication skills both verbal and written.
  • Ability to negotiate and influence.

 

How to apply:

For more information or to apply for this Pharmacovigilance Manager please contact Krishna Pankhania at CK Clinical on 01438 743 047 or email kpankhnia@ckclinical.co.uk. Please quote reference CL22897 in all correspondence.

Click here to apply online now.

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