http://www.newscientistjobs.com/jobsNew Scientist Jobshttp://www.newscientistjobs.com/jobs/job/drug-safety-signal-detection-risk-management-director-united-kingdom-200638495.htmThu, 12 Nov 2009 15:31:00 +0000181540Drug Safety - Signal Detection / Risk Management Director RBW Consulting is working closely with a highly regarded Pharma who, due to growth, have an excellent opportunity for an Evaluation and Risk Management professional to join an outstanding team. The successful candidate will be responsible for all drug safety evaluation and risk management work on a range of products. This includes safety signal detection, labelling, aggregate safety reports for regulatory agencies, signal work-up documents, risk management plans (in liaison with other departments), responses to regulatory safety enquiries and safety analyses for other submissions to regulatory agencies. Ideally, you should have a Masters / PhD, 3+ years Pharmacovigilance experience and already be recognised as a safety subject matter expert. For full details, contact Lloyd Dennis - lloyd.dennis@rbwconsulting.com http://www.newscientistjobs.com/jobs/job/career-opportunities-in-drug-safety-pharmacovigilance-uxbridge-200634059.htmMon, 09 Nov 2009 09:26:14 +0000174753New skills in Safety Uxbridge or Cambridge Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in their fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. Drug safety is a key part of the development and life cycle management of these medicines. Our European regional Safety team, based in the UK, has an important role in Amgen’s Global Safety organisation, focusing on the therapeutic safety needs of patients, healthcare professionals and regulators. We work with our innovative products within the legislative framework of a highly regulated industry and use specialist systems and professional expertise to understand and enhance product safety in support of optimum patient care. We have some exciting opportunities within our regional Safety team to work on a range of projects as we move into a very dynamic phase in the evolution of the Global Safety organisation. There are database, product-related and educational initiatives to suit the skill sets of the successful candidates. We need two enthusiastic, versatile, high-calibre individuals who have a real desire to apply their scientific background to explore a career in Safety. With a good degree in life sciences, pharmacy or another healthcare subject, ideally you will have some knowledge of the pharmaceutical industry, possibly gained while working in an area such as pre-clinical or clinical development, data management, QA/QC or product quality. Alternatively, you may be seeking a change of direction from a current academic or healthcare environment. You will also have good team working and organising abilities, diplomacy and interpersonal skills, as well as high proficiency in verbal and written communication. If you would like to join our business at this exciting time, then please apply online, attaching your covering letter, via the job posting ‘Safety Associates’, by clicking the Apply Now button below. Closing date: 27th November 2009. These two posts provide initial eleven month assignments. Candidates should be available for interviews during the week commencing 23rd November or 30th November. http://www.newscientistjobs.com/jobs/job/pharmacovigilance-physician-south-east-200633353.htmFri, 06 Nov 2009 16:00:52 +0000172623Pharmacovigilance Physician Type: Permanent Salary: Flexible depending on experience Location: Home counties Our client is a global company providing clients with expert advice at all stages of the drug development process. They offer a range of services including consulting, development, regulatory and pharmacovigilance management. The main purpose of the role is to provide pharmacovigilance expertise and advice on medical safety aspects of client projects. Main Duties * To ensure all post marketing pharmacovigilance work conducted or planned has adequate safeguards with regard to patient safety and is ethical. * To work with and on behalf of Project teams to overview and assess adverse events and adverse event patterns * To provide medical oversight of post marketing pharmacovigilance services. To assist in providing medical oversight in pre-approval and peri-approval pharmacovigilance services * To provide medical review and writing support (case narratives, PSURs, ASRs) * To represent the company at client meetings where medical/pharmacovigilance issues need to be discussed * To be the designated signatory, if appropriate, where this is required by a medically qualified person * To act as a QPPV/deputy QPPV on behalf of clients, if required * Where necessary to provide strategic input into clinical development programmes Requirements * Relevant Medical qualifications (to include at least one higher medical qualification), significant and recent direct medical experience * Expertise in pharmacovigilance processes and associated medical issues (minimum 5 years) including PSURs, literature search review and AE management * Knowledge of medical monitoring * Therapeutic knowledge to provide input into project design, proposal development and bid preparation in a range of therapeutic areas: * Computer literate/ effective use of available technology For more information or to apply please email peter@clinicalprofessionals.co.uk or call 0118 959 4990 Key words: Periodic safety update reports safety signal detection clinical pharmaceutical biotechnology medical devices CRO clinical trials clinical development pharmacology health medical research drug safety pharmacovigilance adverse event reporting aris g Arisg PSUR adverse event case processing ADR data physician GMC QP narrative Argus SAE reconciliation safety PV DS PVG PVO SUSARs SARs GMC We are dedicated to the clinical research industry, offering candidates a unique service including our free \"Pipeline Watch\" career advisory consultation. To find out more call us on 0118 9594990 or email apply@clinicalprofessionals.co.uk http://www.newscientistjobs.com/jobs/job/pharmacovigilance-physician-south-east-200632279.htmThu, 05 Nov 2009 16:00:59 +0000170175Pharmacovigilance Physician var addthis_pub="jobsiteuk";var addthis_options = 'print, favorites, facebook, myspace, twitter, linkedin, delicious, more'; Pharmacovigilance Physician Type: Permanent Salary: Flexible depending on experience Location: Home counties Our client is a global company providing clients with expert advice at all stages of the drug development process. They offer a range of services including consulting, development, regulatory and pharmacovigilance management. The main purpose of the role is to provide pharmacovigilance expertise and advice on medical safety aspects of client projects. Main Duties * To ensure all post marketing pharmacovigilance work conducted or planned has adequate safeguards with regard to patient safety and is ethical. * To work with and on behalf of Project teams to overview and assess adverse events and adverse event patterns * To provide medical oversight of post marketing pharmacovigilance services. To assist in providing medical oversight in pre-approval and peri-approval pharmacovigilance services * To provide medical review and writing support (case narratives, PSURs, ASRs) * To represent the company at client meetings where medical/pharmacovigilance issues need to be discussed * To be the designated signatory, if appropriate, where this is required by a medically qualified person * To act as a QPPV/deputy QPPV on behalf of clients, if required * Where necessary to provide strategic input into clinical development programmes Requirements * Relevant Medical qualifications (to include at least one higher medical qualification), significant and recent direct medical experience * Expertise in pharmacovigilance processes and associated medical issues (minimum 5 years) including PSURs, literature search review and AE management * Knowledge of medical monitoring * Therapeutic knowledge to provide input into project design, proposal development and bid preparation in a range of therapeutic areas: * Computer literate/ effective use of available technology For more information or to apply please email peter@clinicalprofessionals.co.uk or call 0118 959 4990 Key words: Periodic safety update reports safety signal detection clinical pharmaceutical biotechnology medical devices CRO clinical trials clinical development pharmacology health medical research drug safety pharmacovigilance adverse event reporting aris g Arisg PSUR adverse event case processing ADR data physician GMC QP narrative Argus SAE reconciliation safety PV DS PVG PVO SUSARs SARs GMC We are dedicated to the clinical research industry, offering candidates a unique service including our free \"Pipeline Watch\" career advisory consultation. To find out more call us on 0118 9594990 or email apply@clinicalprofessionals.co.uk http://www.newscientistjobs.com/jobs/job/research-scientist-senior-research-scientist-protein-sciences-united-kingdom-200624783.htmThu, 29 Oct 2009 13:37:43 +0000158150MedImmune, the global biologics unit of AstraZeneca, is committed to developing better medicines that help people live healthier, longer and more satisfying lives. The company is focused on the areas of infection, respiratory and inflammatory disease, oncology and neuroscience, with two marketed products and a robust pipeline of promising new product candidates. MedImmune’s state-of- the-art Cambridge site (formerly Cambridge Antibody Technology) is home to around 390 employees, and serves the company’s European hub for research and development. As part of the Protein Sciences team the individual will be responsible for cloning protein targets, expressing recombinant proteins in a variety of host cells and purifying the recombinant proteins. A particular focus of the role will be cloning, expression and purification of multi-spanning membrane proteins and their reconstitution into liposomes. You will have: Practical experience in modern molecular biology techniques and their application to the cloning and expression of proteins in prokaryotic and eukaryotic host cells. Practical experience of protein purification using current purification platforms and chromatographic techniques (e.g. AKTA) Practical experience of detergent solubilisation of membrane proteins and their purification and reconstitution into artificial lipid bilayers (e.g. liposomes, magnetic proteoliposomes). Up to date knowledge of developments in these technical areas (e.g. new platforms). Communicating with project teams to ensure project needs are discussed, understood and fulfilled and providing intellectual input into project strategy. Maintain scientific knowledge and best practice with respect to cloning, expression and purification of proteins with a particular focus on multispanning membrane proteins. Providing written reports of work as required and oral presentation of work to project teams. Recording and conducting work according to current codes of practice (e.g. lab book recording and health and safety legislation). Additional responsibilities would depend on the candidate but could be extended to biophysical characterisation of proteins and affinity determination for protein-protein interactions. Experience You will hold a PhD (or have equivalent industrial experience) in Molecular Biology, Protein Biochemistry or related discipline in addition to experience of working within an industrial environment. Evidence of working successfully in a project team. Knowledge/Skills Essential: Molecular biology (e.g. PCR, cloning), extraction of membrane proteins using detergents and their subsequent purification, reconstitution of membrane proteins into liposomes or other forms of lipid bilayers. Desirable: Protein analytical techniques, protein-protein interaction analysis. Behavioural Competencies Essential: Good communicator. Strong evidence of team working. Ability to work independently and accurately. Evidence of an interest in innovating. Ability to deliver to multiple assigned goals. Ability to communicate complex information to a non-specialist audience. http://www.newscientistjobs.com/jobs/job/senior-project-feasibility-associate-maidenhead-200619420.htmFri, 23 Oct 2009 12:53:32 +0000149610COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance’s impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner. About the Job Coordinate the delivery of the Global Site Services (GSS) component of assigned studies across a region or globally. Including overall accountability for delivery to time, cost and quality • Leading the drafting and finalization of Study Plans related to GSS activities • Responsible for directing day to day work flow of assigned GSS staff in the collection and review of investigator and regulatory documents • Oversee site start-up activities for studies in which GSS is working with customers: ensure compliance with timelines / milestones for site activation through planning & review of work with individual team members • Ensuring, through training and quality monitoring, that these documents meet the specifications required by local regulations, EU Clinical Trial Directive, ICH-GCP, FDA regulations (for IND studies) and/or the study sponsor • May be responsible for line management of GSS personnel: mentoring, performance management: ensuring understanding of project specific and GSS policies • Works with staff in Operational Strategy & Planning, Business Development and Operations, to provide feasibility data and other relevant data critical to the ability of the organization to develop evidence-based plans for the successful implementation and conduct of global clinical trials • Provide Covance input into Drug Supplies coordination as applicable, including authoring Clinical Trial Supplies Plan (including liaison with external vendors and clients) and management of labeling requirements. About You: University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) with typically 4 years work experience in study start-up activities, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 6 years work experience in study start-up activities, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations will be considered. Preferred: • An understanding of aspects surrounding Covance business development (time and cost estimates, bid defense, contracts) • An understanding of relevant Covance procedures, including Standard Operating Procedures • Thorough knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; extensive experience of investigator start-up documents; interaction with operational project teams and investigative sites • Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe • Excellent communication / writing skills • Ability to motivate self & others when working under pressure to meet deadlines • Demonstrated ability to delegate effectively, co-ordinate a team to achieve results • Detail and process oriented • Good organizational skills • Positive attitude and approach • Strong computer skills with an ability to understand, access and leverage technology alternatives • Abilities to review/analyze relevant data so as to assist in building evidence-based clinical trial strategies • Ability to work independently We Offer Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. There is no better time to join us! Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us. http://www.newscientistjobs.com/jobs/job/senior-associate-drug-safety-maidenhead-200618750.htmThu, 22 Oct 2009 14:37:00 +0000148202COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance’s impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner. About the Job • You will take the lead on projects • Regularly communicate with the client either by phone or by email • And case manage projects About You • Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, Chemistry • You should have an ability to identify potential issues very early on and provide solutions • Typically have 2-5 years experience within Drug Safety • Work well under pressure • Within set timelines • Be organised • And have the ability to prioritse and adapt to changing situations with ease • Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, Quality Assurance or Drug Safety. Preferred: We Offer Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us. http://www.newscientistjobs.com/jobs/job/manager-drug-safety-crawley-200618613.htmThu, 22 Oct 2009 13:29:23 +0000148164Covance is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance's impressive history of company stability and growth. We've achieved these results by fostering a work environment that encourages, develops and leverages our team's capabilities. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner. About the Job * You will be managing a team of Associates * Working on Global projects * And contributing to the Quality aspects of the teams output About You * You should be working in a supervisory capacity in a Drug Safety environment * Have worked in safety surveillance and case management * And worked in a European or global environment What We Are Looking For * Someone with a proactive approach to what is happening in their department * Display leadership and coaching skills * And be able to communicate at all levels * Industry experience of which 4 years is relevant to drug safety knowledge. *Relevant experience includes experience in the pharmaceutical, biotechnology or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, Quality Assurance or Drug Safety. To be considered for this position, candidate must possess relevant experience specifically in safety/AE processing (minimum of 4 years of safety experience in both pre and post-marketing safety reporting) along with 1-2 years supervisory experience. We Offer Covance's ongoing success offers team members unsurpassed growth and career development opportunities. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. There is no better time to join us! Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us. http://www.newscientistjobs.com/jobs/job/bioanalytical-development-scientist-biochemist-hplc-elisa-pharma-united-kingdom-200610936.htmTue, 20 Oct 2009 08:57:54 +0000146388Bioanalytical Development Scientist (Biochemist HPLC/ ELISA) c£25-30k South Ref: AF/015026 A fantastic opportunity for a bioanalytical development scientist (HPLC/ ELISA) to support the Process Development Department has arisen for a pharmaceutical organisation. The scientist will work in an expanding team, established to support the manufacture of medicines. The analytical methods used include SDS-PAGE, iso-electric focusing, HPLC methods, ELISAs and spectroscopic techniques; as well as other methods employed in pharmaceutical analysis, such as Karl Fischer and particle counting. The analytical capabilities of the team are expected to expand further. Job Responsibilities • To analyse samples, using appropriate methods, to the required standards, producing high quality data. To develop and validate analytical methods, as appropriate. • To ensure that equipment/instrumentation is calibrated and maintained and that laboratory records/documentation comply with GMPs. • Performs job responsibilities in compliance with cGMPs and all other regulatory agency requirements. • To be a member of project teams and to ensure the completion of tasks within agreed timeframes. • Presenting results in oral or written reports to the relevant supervisor and to produce technical documentation packages on projects under the guidance of the supervisor. • To work in compliance with company and regulatory requirements, and to ensure that client-confidential information is protected at all times. Qualifications, Skills and Experience: Life Sciences Background (Biochemistry/ Bioanalytical) Method validation and development using protein structure/function characterization techniques such as: SDS-PAGE, Iso-electric focusing, HPLC methods, ELISA’s, FTIR, Differential Scanning Calorimeter (DSC), Western Blot, Spectroscopic techniques and pharmaceutical techniques such as Karl Fischer and particle counting. To Apply If you would like to be considered for this role, please contact Alison Fisher at Hudson Shribman Scientific Recruitment, quoting reference AF/014824, outlining your particular skills and experience and their relevance to this post. Please call on 020 7421 5200, or reply via email, entering the job title and reference code in the subject field to alison.fisher@hs-scientific.co.uk For up to date career opportunities please visit www.hs-scientific.co.uk Due to a high volume of applicants only shortlisted candidates will be contacted. If you are not contacted within seven days of submitting your CV please assume that your application will not be taken further. If you wish to receive feedback to obtain why your application was unsuccessful please use the contact details provided on the advert. http://www.newscientistjobs.com/jobs/job/study-director-in-bioanalytical-services-yorkshire-200582004.htmTue, 29 Sep 2009 12:08:24 +0000125824As a Study Director you will ensure that the studies are carried out to the required standards and approve the study data. You will be the single point of study control and have overall responsibility for the scientific, technical and regulatory conduct of studies allocated to you, as well as for the interpretation, documentation and reporting of results. You will have the responsibility to conduct all work in compliance with applicable regulatory requirements, and specifically those regulations (GxP) specified in the study plans, protocols, or work agreements governing the work in which they are involved. Examples of other responsibilities are: • To ensure that the study is performed in accordance with the study protocol and the Covance standard operating procedures. • To ensure that the study is performed to the required scientific and regulatory standards. • on time delivery targets (protocols, results, reports) Understands PBU process and financial/resource issues. Ensures all studies are costed and quoted. • To be aware at all times of study status and anticipate problems that may affect timing, quality etc taking appropriate action to resolve such problems • Ensure that all study communication is documented and maintained and carried out to meet client requirements • Demonstrates knowledge of customer requirements and plans accordingly (timelines, critical deadlines etc) • Provides client feedback to team • Produces study protocols and reports to meet client and regulatory requirements • Proactively manages client and study changes to meet timelines and ensure all additional costs are captured (workscopes) http://www.newscientistjobs.com/jobs/job/study-director-protein-chemistry-yorkshire-200581466.htmTue, 29 Sep 2009 09:24:24 +0000125766Act as Study Director on GLP and GMP studies where you will be the main point of contact for analysts, supervisors and clients, taking responsibility for ensuring studies meet regulatory and Client requirements. Examples of other responsibilities are: • To ensure efficient development and implementation of client-specific study methods within the Protein Chemistry group. • To ensure day-to-day monitoring and supervision of analyst’s work and ensuring procedures are regulatory and scientifically sound and meet Client deadlines. • To provide supervisory and operational support necessary for the performance of a wide variety of studies and experimental procedures. • To be responsible for the day to day performance of routine assays in Protein Chemistry, particularly with respect to regulatory requirements, trouble shooting, scheduling, method development and validations. • Take responsibility for the technical and practical aspects of designated projects. • As required, provide appropriate technical training for Protein Chemistry staff to develop their skills and the group knowledge base. • Work with senior analysts in taking responsibility for technical aspects of projects undertaken within the group, maintain track of team activity and strive to keep projects on schedule.