Safety Surveillance Associate – Kent

Farhad Salam is recruiting for a Safety Surveillance Associate to join a global pharmaceutical company at their site based in Kent.

The role mainly consists of Safety Surveillance and Risk Management operations so as to effect product safety signal detection, risk assessment and minimising safety risks.

An MD or DVM is preferred, though PhD, PharmaD or MSc are also appropriate qualifications for an application.

Find out more and apply here

 

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New CEO Appointed at AstraZeneca

As reported by The Wall Street Journal, the UK pharmaceutical giant, AstraZeneca, has appointed a new CEO, Pascal Soriot.

Dr Soriet was formally chief operating officer at Roche’s pharmaceutical division since 2012 and has worked in the pharma industry since 1986. He will join AstraZeneca on 1st October 2012.

It is hoped that Dr. Soriet’s strong experience will help give the company a boost as they face one of the industry’s largest patent expirations. Drugs such as Seroquel and Nexium (which account for 44 per cent of their sales) lose patent protention from this year through the end of 2014. Therefore, Soriet will be focusing on searching for licensing deals, partnerships and acquisitions of late-stage assets in order to replenish AstraZeneca’s drug pipeline and increase sales.

 

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New CEO Appointed at AstraZeneca   New CEO Appointed at AstraZeneca   New CEO Appointed at AstraZeneca   New CEO Appointed at AstraZeneca

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Bayer Healthcare and Covance announce a long term partnership

Pharmatimes reported that Bayer HealthCare has announced a long-term strategic partnership for clinical drug development with US-based provider CovanceBayer and Covance will work on clinical drug development, including research and development related to Phase II-IV clinical studies and central laboratory services.

Bayer Healthcare  aims to better leverage Covance’s broad range of experience and services across the R&D portfolio to attain best in class operational delivery, efficiency and quality while also delivering significant financial benefits to both organizations.

John Watson, president, strategic partnering, and chief commercial officer at Covance said “We are extremely proud to have established an enduring relationship with Bayer HealthCare built on trust and proven performance that is now elevating to a strategic partnership,”

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Biostatistician – East Midlands

Priya Mukherjee at CK Clinical is currently recruiting for a Biostatistician to work for an expanding clinical trials organisation in the East Midlands.

Responsibilities:

As a Biostatistician you will assist the Director of Biostatistics with the statistical analysis and reporting of clinical trials. The main responsibilities of this role will include:

  • To perform programming, validation and production of regular statistical summaries for ongoing trials.
  • To produce ad hoc statistical summaries when requested during the course of a trial.
  • To liaise with internal departments, sponsors and other third parties regarding statistical issues and reporting requirements.
  • To extract information from the system during the course of a trial e.g. summaries, data listings, study data sets.
  • To assist in the preparation of statistical analysis plans.
  • To perform specification, programming and validation of analysis datasets.
  • To undertake the preparation of final reports, including the production of tables, listings and figures, and report writing.
  • To become familiar with developments in statistical software used in-house.
  • To assist in the maintenance of documentation e.g. the description of programs and validation.
  • To assist with Quality Assurance and Audit requirements.
  • To assist the Director of Biostatistics with all other aspects of the job as required.

Qualifications and skills:

The successful applicants for this Biostatistician role will be educated to degree level in mathematics, statistics or another subject with a strong statistical component (OR Equivalent) and should have proven experience of using statistics in a clinical research environment, including SAS programming experience. You must also possess good communication and time management skills, and work in an inquisitive manner whereby you question the validity of all outputs produced.

How to apply:Priya Mukherjee - Senior Biometrics Recruiter at CK Clinical

Apply online now:

For more information or to apply for this Biostatistician role please contact Priya Mukherjee on 01438 743 047 or email pmukherjee@ckclinical.co.uk. Please quote reference CL24441 in all correspondence.

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Quintiles named one of the top places to work in UK

The Business Wire has reported that Quintiles has been named one of the top workplaces in the United Kingdom by the Great Place to Work Institute. Placing fourth, the accolade follows awards in Germany, Ireland, Italy, and Spain in 2012.

The biopharmaceutical services firm gained high scores for its sense of pride and camaraderie, with its efforts in corporate social responsibility, well-being and work-life balance rated above 2011 benchmarks.

Lindy Jones, Quintiles UK site head said“This honour reflects our efforts to attract and develop talented individuals to help the biopharmaceutical industry increase research productivity, control costs and achieve greater returns on marketing and sales spending……….We are very proud to be recognised as a Great Place to Work for 2012 in multiple European markets.”

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Pfizer submit plans for $129M expansion in Belgium

Fierce Pharma Manufacturing reported that Pfizer may be planning a $129 million expansion at its manufacturing campus in Puurs, Belgium, which is to be announced next week.

Paul Schoeters of the Christian trade union ACV said that plans for a new manufacturing plant and packaging line have been submitted to the works council. He says about 100 new jobs are anticipated to be created due to the expansion.

The union rep also said “This is a crucial investment if one considers the economic climate. It indicates America’s confidence in Puurs and serves as a tremendous boost for employees here,’

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GSK gets approval from FDA for Acne treatment

Pharmatimes reported that GlaxoSmithKline‘s acne treatment Fabior foam has been given approval by regulators in the USA.

The US Food and Drug Administration has approved GSK unit Stiefel’s Fabior (tazarotene) foam. It is the only retinoid in a topical foam formulation for the treatment of acne vulgaris in patients 12 years of age and older

Acne is the most common skin problem in the US, affecting about 40 – 50 million Americans at any one time. Therefore this is welcome news for those who suffer with the condition.

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Data Manager – Paris

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

Responsibilities:

As Data Manager the main purpose of your role will be to:

  • Provide timely and professional ongoing management of project & clinical trial data by identifying and resolving errors and inconsistencies in eCRF data to ensure consistently high standard database(s) with respect to cost, quality and timelines
  • Serve as Project Data Manager for large projects or multiple smaller projects providing professional Data Management input on ICT(s)
  • Ensure consistency of protocols, Validation and Analysis Plans (VAPs) & Project eCRFs for all trials within assigned projects
  • Have business understanding of the compound profile (CDP/TPP) to identify and assist in successful application of data management processes
  • Respond to Health Authority requests for data management issues
  • Support and assist Assistant Data Managers and other Data Managers for allocated trials within assigned project(s)
  • Provide input, review, and maintenance of global working practices and standards
  • Contribute to the development of the Data Management organization through his/her leadership role within the DM Group
  • Track and report status and progress of data management for allocated trials and be proactive to ensure smooth and successful timely locking of databases
  • Ensure appropriate company tracking systems are up to date and accurate
  • Lead and support clinical & non-clinical special projects
  • May deputize for Data Management Group Head and assist in coaching, training and mentoring of Data Management staff.

Qualifications and skills:

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

  • University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
  • Languages: Fluent English (oral and written) and French
  • Ideally 5 or more years experience in drug development, with at least 4 years in Data Management activities
  • Project team leadership experience required
  • Good technical and problem solving skills
  • Thorough understanding of clinical trial methodology, GCP and medical terminology
  • Ability to work independently, under pressure, demonstrating initiative and flexibility
  • Attention to detail and quality focused
  • Good organizational, planning and project management skills
  • Good interpersonal and communication skills and ability to operate effectively in an international environment
  • Good negotiation skills
  • Thorough understanding of physiology, pharmacology, clinical study objectives and the drug development process
  • Ability to mentor, coach within Data Management and cross functionally, and train internal and external partners.

How to apply:

Apply online:

For more information or to apply for this Data Manager position, please contact Mylene Paumier on 01438 743047 or email mpaumier@ckclinical.co.uk. Please quote reference CL24263 in all correspondence.

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NNovartis buys Fougera Pharmas for $1.525 Billion

Novartis has agreed to buy specialty dermatology generics company Fougera Pharmaceuticals for USD 1.525 billion.

Fougera is a specialty dermatology business with 2011 net sales of USD 429 million, and employs 700 people across its two primary sites, located in New York

The agreement will create a strong global growth platform for Sandoz, which is the pharmaceuticals division of Novartis. Sandoz will use its leading position both in the US generics sector and its presence in over 130 countries worldwide to expand Fougera’s existing sales base and bring its broad dermatology portfolio to new markets around the world.

Jeff George, Global Head of Sandoz said “The addition of Fougera’s leading portfolio further strengthens Sandoz’s differentiated products strategy and improves our ability to help patients and customers around the world by providing easier access to high quality, affordable dermatological medicines. Fougera brings us valuable technical capabilities in the area of topical dermatological products, particularly in the development and manufacturing of semi-solid forms such as creams and ointments,”

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Amgen Investment creates 100’s of jobs in Ireland

Recruiter reported that  Amgen are investing £123 million in their site n Ireland, which will create up to 100 new jobs.

The US biotechnology company’s expansion program in Dun Laoghaire will create 100 jobs and also 350 construction jobs in the construction period.

The expansion includes the construction of an 11,700 sq-metre building extension, a new production plant, an expanded warehouse and the major refurbishment of its existing buildings.

Martin VanTrieste, senior vice-president of Quality at Amgen said ““We are very pleased to expand our investment in Ireland…….As we expand internationally, Dun Laoghaire will enhance our global production capability, ensuring continuity of supply of Amgen medicines for seriously ill patients worldwide.

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