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Medical Information Manager – Germany

Tuesday, July 3rd, 2012

Mylene Paumier at CK Clinical is recruiting for a Medical Information Manager to join a global pharmaceutical company at their site based in Germany on a permanent basis.

Responsibilities:

As Medical Information Manager you will be responsible for:

  • Management and accountable for correctness, actuality, plausibility, consistency and safety of all informative texts (spc, leaflet, publicity)
  • Medical-pharmaceutical consulting hotline
  • Medical and pharmaceutical correspondence with patients, pharmacists, doctors
  • Correspondence with agencies wrt leaflet and spc
  • Contact point for any medical and pharmaceutical queries from internally or externally, in close cooperation with QA

You will also be responsible for the management and accountability of PV and medical information related SOPs. Official local “Stufenplanbeauftragter” according to German law. You will be responsible for:

  • Managing all local aspects of PV for DEA
  • Cooperating with EU PV team wrt Psurs, audits
  • Collect quality information concerning adverse drug reactions (ADRs) with Company products
  • Follow-up local cases for further clarification with the reporter and HCPs and completeness when necessary (according to the SOP)
  • Forward the ADR/AE information to the Pharmacovigilance Department Region II as per the applicable SOP
  • Complete the management and reporting of processed AE/ADR cases received locally or from the Region II Pharmacovigilance Department to the local CA if required in accordance with local regulations
  • Ensure the receipt of product quality complaints and communication to the Medical Information team
  • Ensure timely submission of the PSURs distributed to them and maintain a submission log
  • Ensure local literature monitoring
  • Upon the receipt of the updated Reference Safety Information inform Regulatory Departments of variation requirements to the local SPCs
  • Ensure and monitor Pharmacovigilance compliance with local regulations
  • Notify the EEA QPPV regarding any new or additional national Pharmacovigilance requirements for the countries of responsibility

Qualifications and skills:

As Medical Information Manager, you will have the following qualifications, skills and experience:

  • Excellent and broad pharmaceutical and pharmacological knowledge
  • Excellent understanding and knowledge of relevant local end EU legislation, guidelines and best practice related to pharmacovigilance and medical information
  • Practical work experience in a public or hospital pharmacy
  • Good understanding of technical aspects (regulatory timelines and requirements, QA, IP, manufacturing aspects etc)
  • Excellent German and fluent English

Mylene Paumier - Recruiter at CK ClinicalHow to apply:

For more information or to apply for this Medical Information Manager position, please contact Mylene Paumier on 01438 743047 or email mpaumier@ckclinical.co.uk.  Please quote reference CL24562 in all correspondence.

 

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Celgene recruits new UK and Ireland Medical Director

Tuesday, January 10th, 2012

Pharmaceutical Jobs, Pharmaceutical Recruitment, UKAs reported by InPharm, the multinational biopharmaceutical company, Celgene as recently recruited a new UK and Ireland Medical Director.

Celgene’s newly appointed Medical Director, Dr David Gillen, previously held the position of Medical Director at both Wyeth and Pfizer, and also joined Gilead Sciences as Head of International Medical Affairs in 2010.

This is great news for Celgene as Gillen has great experience of working with external stakeholders such as NICE and has also actively promoted closer collaboration between the NHS, academic medicine and the biopharmaceuticals industry.

Speaking of his new appointment, Gillen stated, “I am delighted to be appointed as medical director at Celgene and look forward to working with the team in an area that I’m passionate about. This is a very exciting time as Celgene’s portfolio expands and I can’t wait to build on the excellent work that’s already being undertaken.”

General Manager of Celgene in the UK and Ireland, Samantha Pearce, described Dr Gillen as one of the most  “well respected and experienced medical leaders in the UK pharmaceutical industry. We very much welcome David in what is a very exciting time for Celgene and really look forward to him being part of our future success.”

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Divide in UK Cancer Drug Access

Tuesday, September 6th, 2011

iStock_000006963239Medium1-150x150 (2)Pharmatimes.com has reported that there is a wide gap between England, Wales and Scotland in terms of access to life-extending cancer treatments.

England has 24 treatments not routinely available in Wales, and 23 similarly limited in Scotland. A Welsh patient is five times less likely to receive novel cancer drugs, and a Scottish patient three times less likely than their English counterparts. The costs to improve this care has been estimated by the Rarer Cancers Foundation (RCF) at £3.3 million in Wales, rising to £10 million over three years, and £5 million in Scotland, rising to £20 million.

 The RCF believes the Scottish and Welsh governments have shown a “concerning degree of complacency” in regards to cancer treatments. However, the governments have replied, arguing that certain processes and appeals can grant access to cancer drugs unavailable generally. Andrew Wilson, chief executive of the RCF calls the divide “devastating,” with access to cancer drugs restricted by where a patient lives at odds with the rest of the NHS. The RCF is pressing for a Cancer Drugs Fund, which has benefitted thousands across England, to be put in place in Scotland and Wales as well.

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Government’s Health Bill Criticised

Friday, September 2nd, 2011

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The government’s Health and Social Care Bill is coming under criticism from campaigners, reports pharmatimes.com.

Events are planned to coincide with the report stage of the Bill, as well as a candlelight vigil being held outside Parliament when MPs vote on the Bill. UNISON, the UK’s biggest public sector trade union, believes that the Bill will reduce the quality of patient care, waste money and lead to more restrictions as costs are wrapped up in hospital bureaucracy. Labour health spokesman, John Healey, also criticised the limited time MPs will be given to look at and debate the proposals.

Pressure group 38 Degrees believes a review of the Bill shows that it will “increase competition within the NHS at the expense of collaboration and integration.” This is because the group understands that the Secretary of State for Health will have certain powers removed. However, the government has replied, saying that the Secretary will be responsible for providing “a comprehensive health service.”

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Massive Investment to Boost Healthcare Research

Tuesday, August 23rd, 2011

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The UK government has announced an £800 million investment into transatlantic healthcare research and development, reports pharmatimes.com.

The “unprecedented” investment is to be put into developing NHS partnerships with universities through the National Institute for Health Research. Collaborations with industry and charities will mean that the UK should become a world leader in regards to health research.

Funding will be provided for biomedical centres and patients with diseases such as cancer and diabetes. Prime Minister David Cameron has said the investment will “ensure [the UK] continues to be at the cutting edge” of biomedical research. Sir John Bell, president of the Academy of Medical Sciences, says the investments into healthcare are “positioning the UK as a preferred site for clinical development by the pharmaceutical and biotech industries.”

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Employment Drive for Mental Health Services

Wednesday, August 17th, 2011

iStock_000006963239Medium1-150x150 (2)NHS manager Alam Kahn, in an article for the Guardian, has reported on how the NHS is taking part in a scheme to employ people in mental health services.

Twenty two graduates from a pool of sixty have been selected for jobs with a starting maximum salary of £21,000. The sixty graduates took part in a one year course which involved three days a week working in a trust and two days studying for a diploma.

Kahn believes that the scheme will encourage others to take up roles within mental health services, something not seen as appealing compared to traditional medical roles. However, as Kahn points out, with a psychotherapist earning £43,000 and psychiatrists earning upwards of £53,000, the lack of interest is baffling. Something that Kahn acknowledges can be off-putting is the need for professional registration, needing experience, training qualification and a proof of competence.

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MSP Fights to Save 150 NHS Jobs

Tuesday, August 16th, 2011

iStock_000006963239Medium1-150x150 (2)Neil Bibby, a Member of the Scottish Parliament, is fighting to save a children’s ward supporting 150 NHS jobs at the Paisley Royal Alexandria Hospital, reports paisleydailyexpress.co.uk.

The closing of the ward is expected to save £1 million annually, but the closure of a children’s ward and loss of so many jobs has caused Mr Bibby to call for the scrapping of the plans in the Scottish Parliament. He has received support from several other MSP. Mr Bibby has stated that the issue of closure has shown “the desire of the community to protect the children’s ward.”

The pressure that would be placed on Glasgow hospital by the closure of Paisley’s ward, and loss of jobs, seems to Mr Bibby to be “motivated by money rather than quality of service.” An NHS spokesman has said that a review is taking into account the opinions of patients and their families, so that if the review concludes there is a need for change their can be “a full public engagement.”

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New LIMS Technology From Thermo Fisher

Monday, August 1st, 2011

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Medicaldevices-business-review.com has reported that Thermo Fisher Scientific has introduced a new Clinical Laboratory Information Management System (LIMS) to support their clinical laboratories.

The LIMS is designed to improve management of lab data and improves communication between physicians and those working within a lab environment. The technology also allows those involved in clinical and molecular diagnostics access to lab and patient data, and gives them a platform through which to effectively manage the data they are given.

Foundation Medicine is using Thermo’s LIMS for cancer diagnostic tests. Foundation’s CEO Michael Pellini said the information will allow doctors to target the molecular subtype of each cancer. Dave Champagne, vice-president of Thermo Fisher Scientific  believes the LIMS has plugged a gap that means results can be sent from lab directly to the patients bedside.

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Sanofi Appoints Strategy Officer

Friday, July 29th, 2011

iStock_000006963239Medium1-150x150 (2)Inpharm.com has reported that French pharmaceutical company Sanofi has taken a on a new chief strategy officer, Dr David-Alexandre Gros.

Dr Gros will oversee the entire group’s business development and acquisition deals, as well as strategic planning and intelligence and the economic evaluation of projects at Sanofi.

Chief executive of Sanofi, Christopher Viehbacher believes Dr. Gros “brings a wealth of experience as a physician, strategic consultant and investment banker.” The Sanofi group hopes that Dr Gros will be able to significantly contribute to Sanofi’s strategy and the improvement of certain aspects within the company.

Dr Gros joins Sanofi following advising various pharmaceutical and biotechnological companies in addition to establishing the Healthcare Investment Banking division at Centerview Partners, California.

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NHS Drug Budget Rising

Monday, July 25th, 2011

iStock_000006963239Medium1-150x150 (2)The NHS drug budget is expected to reach £15 billion by 2014, reports Bloomberg.com.

The increase represents a £400 million growth year on year, the Association of the British Pharmaceutical Industry has said, citing forecasts by leading members in the industry.

Almost two thirds of prescriptions are to over 65s in Britain, therefore it is the aging population that is driving this growth. The NHS spends less than ten per cent of its budget on drugs and medication, down three per cent in the last decade. The use of new medicines, including cancer medicines, accounts for ten per cent of the NHS budget, with the use of new cancer medicines a third of that of the rest of Europe.

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