Pharmaceutical jobs

Regulatory Affairs Executive (CMC)

Our client is looking for an experienced CMC Regulatory Affairs Professional to join their team in Stockley Park. Contract Duration is 6 months and they are looking to pay up to £48.74 per hour. Duties will include Preparation of high quality, Chemistry ,manufacturing and control (CMC) detailed regulatory documents using varied information sources. liaising closely with company personnel to ensure accuracy of such records. Working to agreed deadlines and maintaining records to reflecting project status. responsible for highlighting potential delaying factors promptly to line management and sharing knowledge of regulatory documentation and procedures with others to assist in problem solving. Proactively pursuing process improvement and sharing of best practice. Required Skills CMC experience :good written and oral communication and networking skills. Demonstrate ability to focus and work with attention to detail. Demonstrate ability to retain critical information. Be aware of the contents of a marketing authorization application. Demonstrate team working and effective time management skills. Be a dynamic and highly motivated individual Establish strong relationships and liaise effectively with company sites worldwide. Be proficient in the use of IT packages such as Word and excel. Demonstrate problem solving skills The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the country where the job is based. Carlisle Staffing plc, trading as SRG is an Employment Business/Agency.
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Global Pharmacovigilance Physician

I have a position for a Drug Safety Physician who will be responsible for global safety operations providing medical review of Adverse Event reports, case narratives and analysis of similar events. In addition, this role involves providing expertise and to Drug Safety Physicians and Specialists, including assisting with queries relating to the medical interpretation of Adverse Event reports and laboratory data. You will be a trained physician with GMC registration, broad clinical and drug safety knowledge in post marketing and clinical safety. You will also have demonstrated ability to work in a matrix organisation with a sound knowledge of general medicine and clinical practice and liaise with Regulatory Affairs and develop relationships with other functions.You will be confident in communication clearly with health and industry professionals of all levels, enthusiastic to learn about and understand the drug development process and drug safety regulatory obligations, good time management and attention to detail. Hays Pharma is a trading division of Hays PLC and acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. By applying for this job you accept the T&C’s, Privacy Policy and Disclaimers which can be found at hays.comFor full details please call Anna 0207 922 7141 or email anna.crawford@hayspharma.com
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Associate Director-Drug Safety Physician

Pharmcovigilance Physician role-A Global Biopharmaceutical company based in the UK are expanding the Pharmacovigilance department and continually aim to attract and retain highly skilled and talented people to play an active part in the development of the company in their established and new product pipeline. One of the challenging positions that generate high focus and interest within this product pipeline has just arisen and is the Associate director of Drug Safety (Physician).The Associate Director of Drug Safety–focusing on the therapeutic area of Oncology will demonstrate leadership and manage and investigational and post-marketing regulatory reporting and pharmacovigilance activities for assigned products, prepare and review responses to ad hoc regulatory queries, providing expert supervision in the preparation of company Periodic Safety Update Reports and Risk Management Plans. You will be a fully GMC registered physician or European with broad clinical and drug safety knowledge in post marketing and clinical safety. You will also have demonstrated ability to work in a matrix organisation with a sound knowledge of general medicine and clinical practice. A familiarity with industry principles of drug development, pharmacology, bio statistics, clinical trial methodology and pharmacoepidemiology is preferred.Hays Pharma is a trading division of Hays PLC and acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. By applying for this job you accept the T&C’s, Privacy Policy and Disclaimers which can be found at hays.comFor full details please call Anna 0207 922 7141 or email anna.crawford@hayspharma.comPlease note-only EU applicants will be considered for this role.
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Warehouse and Despatch Manager

SummaryAn exciting opportunity for a experienced and visionary Warehouse & Despatch / Logistics Manager with specific expertise in the running of pharmaceutical warehouse, despatch and logistics services. Other aspects include cold chain consultancy and Lean Six Sigma implementation.The CompanyOur client is a leading global service provider to the drug development sector enabling clients to outsource aspects of product development programmes. The company has assembled a complementary portfolio of services to “engineer a better drug development process through scientific excellence”. With sites in the US and Europe the Bathgate operation undertakes contract packaging and distribution of supplies for clinical trials. The RoleThis is a senior management role with responsibility for the running and development of the Warehouse, Despatch and Logistics operations. Reporting to the Operational Senior Director the position has directly report managers for each of the facilities and around 50 operational staff in total. The role focuses on the management of the overall materials operation and future improvements. These include, and will be achieved through, ensuring regulatory compliances, performance tracking through KPI’s, aligning capacity to business needs, optimising stock management, budgetary management and ensuring accuracy in all areas including despatch and returns. As the senior representative the role will involve liaising and communicating company wide, representing the company at key client meetings, audit hosting management and providing consultancy on cold chain technology matters. A key immediate project and ongoing requirement will be the implementation of Lean Six Sigma and continuous improvement initiatives. ExperienceTo be eligible for this position you need substantial and strong team and individual management skills. These must have been developed in a pharmaceutical or similarly regulated environment which encompassed warehouse, despatch and logistic operations. Expertise in temperature controlled, cold chain operations and Lean Six Sigma will be a very distinct advantage. Any knowledge of clinical supplies or the handling of IMP’s would be a further bonus. Keywords: GDP, GMP, cGMP, GxP, Cold Chain Technology, Supply Chain Manager, Warehouse Manager, Materials Manager, Logistics Manager, Operations Managers, Clinical Supply, Clinical Trial Supply, CTS, CMO, Contract Packaging, Contract Distribution, IMP, Lean Six Sigma, Continuous Improvement, CI, Pharmaceutical, FMCG SLS Services Ltd operates & advertises as an Employment Agency for permanent positions and as an Employment Business for contract/temporary positions
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Clinical Research Associate - level II - Lead

My client, a major player in the Pharmaceutical Industry is currently recruiting for a number of CRAs, from CRA II to Lead CRA to join their growing team.This is a great opportunity for a clinical professional with a minimum of 2 years experience to take on a role with more mentoring then monitoring. Working initially within their Endocrinology team with a view into move into Urology. This organisation is open to freelance and permanent position based in the South / South West. - Home based working could be open to consideration for the right candidate.Duties and responsibilities: You will be responsible for performing tasks as assigned by manager which include but are not limited to preparing, collecting, and tracking master study level documents and site non-regulatory documents, reviewing, updating, and testing clinical systems, producing reports on clinical status, trends, and metrics, facilitating communication across all departments, supporting the monitoring team and study sites with relevant study information, and supporting clinical operations. You will be expected to complete assigned tasks within agreed upon project priorities, timelines and quality specifications. Minimum requirements:• B.A./B.Sc. preferably in science or health-related field• Previous experience of clinical study management through start up and close out phases.• Experience of taking oversight or mentoring of more junior study monitors (direct or indirect)Knowledge and Skills• Handle and prioritize multiple tasks simultaneously and maintain flexibility around changing priorities, • Work effectively in a multicultural team/matrix environment.• Understand technical, scientific and medical information, and be able to lead and/or significantly contribute to meetings – solution oriented.• Proven ability to resolve conflict situations and deliver results. • Understanding of clinical study budgets. • Plan, organise, project manage and analyse data, • Demonstrate full competency in Microsoft Office programs.If you would like to hear more about this position call Kerrie Lynch on 0207 6334806 or e-mail your CV to Kerrie.lynch@hayspharma.com – all applications will be treating with the strictest on confidence.
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