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Wednesday, 26 October 2016

Claris Otsuka Private Ltd. (Claris Otsuka) is a Joint Venture between Claris Lifesciences Ltd., India, Otsuka Pharmaceutical Factory, Inc., Japan, and Mitsui & Co. Ltd., Japan, for Claris’ Infusion Business in India and Emerging Markets. We primarily manufacture & market products across multiple markets and therapeutic segments. Being a leader in intravenous nutrition products, we are committed to being the best partner of patients and healthcare professionals in the field of clinical nutrition.
Job Title : Microbiologist
Eligiblity : B.sc / M.sc Microbiology

Experience : 1 – 5 Years

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Application in plain paper is hereby invited for filling up the following posts on contractual basis at a fixed pay as shown against each for District Health & Family Welfare Society, South Tripura. It will be purely contract basis for a period of 11 (Eleven) months likely to be extended based on performance of employees till the project period only.
Post : Pharmacist (Alio.)

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GlaxoSmithKline Pharmaceuticals Ltd. (GSK Rx India) is one of the oldest pharmaceuticals company and employs over 5000+ people. Globally, we are a £ 27.4 billion, leading, research-based healthcare and pharmaceutical company. In India, we are one of the market leaders. At GSK, our mission is to improve the quality of life by enabling people to do more, feel better and live longer. This mission drives us to make a real difference to the lives of millions of people with our commitment to effective healthcare solutions.
Post : Biostatistician

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Job description 
- participate in the clinical/epidemiological development plan (trial designs, sample sizes, interim analysis, etc.) in collaboration with clinical development managers, safety physicians, clinicians and epidemiologists. In particular, provide statistical, and scientific input into clinical development planning
- be responsible for the statistical designs of clinical/epidemiological studies, creating statistical sections for study synopses and protocols
- input in study set up (case report forms, database, randomization)
- explore new statistical approaches and methodologies through innovative and creative thinking
- propose and evaluate the performance of statistical methods in order to prepare statistical analysis plans
- write and execute SAS programs to analyze the data and to report results creating tables and standard listings
- perform statistical analysis, run simulations and discuss with internal and external experts
- support scientific writers and clinicians to correctly interpret the statistical results and align them with the clinical report conclusions
- write the statistical sections of clinical study reports, statistical publications and prepare materials for publications and create statistical text for clinical study communications
- input in standard processes (review of Standard Operating Procedures, guidelines, definition of new processes needed)




Job Description

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    Immediate Openings for IP-DRG Medical Coding -  @ Vee Technologies 
    Job Description: 

    2+ Years of experience in IP-DRG Coding.

    Coding certification like CIC, CPC, CCS, CPC-H, CCS-P. is added advantage.Apply now

Job Description


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  • End to End Case processing in Safety database (Argus)/ application including Case Narrative writing/ medical writing in accordance with source data. 
  • Processing of Spontaneous, regulatory, clinical trial and literature cases/ all type of case reports
  • Seriousness and Listedness (expectedness/ event labeling) assessment
  • Coding of events, drugs, medical history and lab test as per MedDRA & WHO dictionary.
  • Reconciliations of records
"Artemisinin treats malaria faster than any other drug. It can clear the pathogen from the bloodstream within 48 hours," says senior author Shashi Kumar, of the International Centre for Genetic Engineering and Biotechnology in New Delhi, India. "Our research is focused on finding a way to make this drug available to more people."
Malaria infects more than 200 million people every year, according to the World Health Organization, and kills more than 400,000, mostly in Africa and Southeast Asia. The majority of those who live in malaria-stricken areas cannot afford to buy artemisinin. The drug's high cost is due to the extraction process and largely to the fact that it's difficult to grow Artemisia annua (sweet wormword), the plant that is the original source of the drug, in climates where malaria is common, such as in India. Advances in synthetic biology have made it possible to produce the drug in yeast, but the manufacturing process is difficult to scale up.

Earlier studies looked at growing the compound in tobacco -- a plant that's relatively easy to genetically manipulate and that grows well in areas where malaria is endemic. But yields of artemisinin from those plants were low.
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source:https://www.sciencedaily.com/releases/2016/10/161020142815.htm
Thermo Fisher Scientific, the world leader in serving science announced the expansion of its Fisher BioServices cryogenic service capabilities in Japan.


This expansion enables its customers to seamlessly conduct clinical trials across multiple geographies and provides patients around the world with access to life changing therapies. As a leading service provider to the cell and gene therapy community, Fisher BioServices is uniquely positioned with the experience, resources, and global expertise to support its customers on their path towards commercialization.
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The facility in Tokyo was expanded to include cryogenic storage and logistics by utilizing a combination of proven components and validated procedures developed with years of experience in the cell and gene therapy business. The new modules within this facility allow Fisher BioServices to configure and replicate each site to meet the specific requirements of individual clinical trials with minimal variation, regardless of volume or geographic location. The facility is also supported by a global comprehensive and integrated Quality System based on regulatory requirements, industry best practices and trained personnel.
“Japan is an increasingly important market for cell and gene therapy companies conducting clinical trials,” said Dennis Barger, Fisher BioServices vice president and general manager. “The addition of cryogenic services to this facility in Japan, combined with our existing capabilities in Europe and the US, enables us to seamlessly support our customers’ global trials as they develop and commercialize their therapies.”



source:http://www.worldpharmatoday.com/Clinical-Trials/thermo-fisher-scientific-expands-global-footprint-to-support-cell-and-gene-therapy-clinical-trials-in-japan

Tuesday, 25 October 2016

The Central Pollution Control Board (CPCB) of India is a statutory organisation under the Ministry of Environment, Forest and Climate Change (MoEF&CC). It was established in 1974 under the Water (Prevention and Control of pollution) Act, 1974. CPCB is also entrusted with the powers and functions under the Air (Prevention and Control of Pollution) Act, 1981. It serves as a field formation and also provides technical services to the Ministry of Environment and Forests under the provisions of the Environment (Protection) Act, 1986.

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Institute of Good Manufacturing Practices India, registered as a non-profit society with Government of India and approved (as a higher/professional Education Institute) by Quality Council of India(QCI) – which is an autonomous body and an accreditation authority for education & vocational training providers under the Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, Government of India -presents unique, friendly and interactive platform to get rid of all your GMP related glitches. IGMPI is also affiliated with Life Sciences Sector Skills Council (SSC) and Food Industry Sector Skills Council set up by National Skill Development Corporation (NSDC).

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For counseling by our experts or prospectus, you may call/write on , +91 8587838177, +91 8130924488, 0120-2427175, 0120-4375280  ffsq@igmpiindia.org mentioning the name of the course and your phone number.
Biocon is an integrated biotechnology enterprise focused on the development of biopharmaceuticals. With successful initiatives in drug discovery and development, bioprocessing, manufacturing and global marketing, Biocon delivers products and solutions to partners and customers in over 75 countries. Biocon has the defining science, world class capabilities and a focused vision to deliver the promise of innovative and affordable medicine to a waiting world. Today, Biocon together with group companies employs more than 5000 employees with approxmimately Rs 2500 crore turnover and is expected to grow further during the current financial year .
Job Title : QA Executive FOR Visakhapatnam

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On line applications are invited for the Posts of the Scientific Officer (Biology), Class-II, in General State Service under the Director of Forensic Science, Home Department (Advt. 47 /2016-17) between date: 18/10/2016, 13.00 Hrs. to date 03/11/2016, 13.00 Hrs.
Post : Scientific Officer

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Job Description
1. Need to do literature search for new projects and for writing patents.
2. market research for new products
3. Documentation
4. SOP write up
5. Identification of materials suppliers and manufacturers, specification and material status.

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Forward your CV to : hr1.vsp@gmail.com  
Job Description:
Clinical Scientific Expert II is responsible for ensuring the collection, review/ reporting of high quality trial data, and study reporting/publishing in compliance with Novartis processes, GCP/ICH and regulatory requirements. In addition, Responsible for ensuring high quality scientific inputs to the clinical development process and support program level activities as assigned.
• In collaboration with Trial Statistician, support development of Reporting and Analysis Planning (RAP) modules in line with program standards.


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• Responsible to provide expert support in development of and implementation of relevant data capture tools in collaboration with CSD, GTL and IIS as documented in data handling plan or equivalent document (e.g. CRFs, protocol deviations, questionnaires, diaries, translations, edit checks) • Responsible for performing expert review of ongoing clinical trial data as outlined in the data handling plan or equivalent, supports GTL to prepare database lock; and performing data reconciliation along the whole trial duration in collaboration with  management.
• Collaborate with Medical Lead/BSL to identify any safety trends; and as needed, reports on trial data to safety and clinical boards (e.g. SMT, GCT, and GPT).


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Job Description:

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Locally coordinate and take responsibility for trial level programming activities (analysis datasets, pooled datasets, listings, tables and figures) of individual Phase I-IV clinical trials to support program programmers and statistician in project level activities.
Be responsible for statistical tasks on assigned clinical trials e.g. RAP.
Maintain efficient interfaces with internal and external customers with support of ONC Biometrics management and the Program Programmer/Statistician.
Make certain that documents and specifications are consistent and comply with company standards by providing input into CRF and data structures tables, listings and figures for phase I-IV clinical trials and submission activities.
Program and deliver, according to specifications, analysis datasets, pooled datasets, listings, tables, and figures for phase I-IV clinical trials and for pooled analysis with high quality and within milestones.
In consultation with the statistician, develop specifications for analysis datasets, pooled datasets, and listings
Maintain records for all assigned projects and archiving of trial / project analysis and associated documentation.
Provide input on process improvement initiatives and participate in non-clinical project activities with support from GH

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Job Description


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Write & review regulatory submissions like IND, IMPD, MAA, NDA, DMF and documents for regulatory advices.
Guidance to cross functional teams on regulatory expectations for US, EU, Japan and major markets.
Ensuring regulatory compliance in cross functional teams and managing cross functional team deliverables.\
Review of CMC, clinical, bioanalytical development related documents & ensure compliance to CTD requirements

Monday, 24 October 2016


 Job Description : 

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  • To work with a variety of medical records and assigns appropriate codes based on medical documentation using CPT-4 and/or ICD-9 and ICD-10 coding guidelines
  • Handle a team of 50 medical coders and responsible for their deliverables.
  • Develop training materials and update the contents that are relevant to the specialty.

Job Requirement :

  • 6+ years of team handling experience along with coding expertise.
  • Strong knowledge in human anatomy and physiology along with any speciality of Medical coding
  • Active CPC certification is mandatory.
  • Excellent communication and presentation skills.
  • Leadership skills in working with extended teams.
  • Should have very good attitude flexible to work in shifts.
  • Understand business requirements and cooperate when needed.
  • Any life science graduate (BPT, nursing, medical transcription preferred)
Please send your resume to kathiravan_u@dell.com

Job Description


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Warm Greetings from Visionary RCM @coimbatore !!!

Immediate Requirement for Freshers in Medical Coding in Visionary RCM Infotech Coimbatore location US Healthcare process

What is Medical Coding???

Medical coding is the transformation of healthcare diagnosis, procedures, medical services, and equipment into universal medical alphanumeric codes. The diagnoses and procedure codes are taken from medical record documentation, such as transcription of physician's notes, laboratory and radiologic results, etc. Medical coding professionals help ensure the codes are applied correctly during the medical billing process, which includes abstracting the information from documentation, assigning the appropriate codes, and creating a claim to be paid by insurance carriers

Job Description

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  • Prepare and procure documents for clinical dossiers for DCGI and/or USFDA submission; as applicable
  • Prepare dossiers for EC submission
  • Assist PM in site selection process and document collection
  • Facilitate and coordinate with investigator and site for EC submission and approval
  • Prepare Confidentiality Disclosure Agreement (CDA), Feasibility Questionnaires and Clinical Study Agreement (CSA) with investigators in collaboration with the project manager
  • Get trained on the study and documentation requirements
  • Prepare for kick-off meetings to train vendor representatives involved if out-sourced activity for monitoring.
  • Prepare presentation and documents and Start up kits for site initiation
  • Coordinate with translating and back translating agencies for PIS ICF and other associated documents
Job Description 

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Report preparation [e.g. Periodic Safety Update Reports (PSURs), Addendum PSURs, Bridging Reports, PSUR Line Listings, US PADERs] from aggregate data for products, in accordance with client conventions and requirements;
Quality checks of aggregate reports; Signal detection-related analyses and reports including cumulative analyses, issue event analyses, Drug Safety Reports , review of published literature and case listings; Vigilance over important/designated medical events;
Interaction with client personnel to discuss potential signals and issues detected with products; Support preparation and maintenance of Risk Management Plans;
Follow-up and interaction with clients to obtain incomplete/missing information, with a view to resolving and clarifying issues;
Performing medical review of individual case safety reports (ICSRs); performing medical review of narratives for Clinical Study Reports (CSRs);
Providing medical advice to drug safety scientists to assist them with processing of ICSRs and CSR narratives;
Maintaining an excellent knowledge of the adverse event safety profile of assigned drugs, labelling documents, and client guidelines and Standard Operating Procedures (SOPs);
Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for report submissions;
Maintaining records in compliance with guidelines and SOPs



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Job Description


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1.Responsible for authoring regulatory/ safety documents such as Protocol, CSR,PBRER/PSUR, Subject Narratives, Aggregate Reports, RMPs and others
2.Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations
3.Ensure that clinical documents adhere to current global standards, FDA, ICH and GCP guidelines and are in accordance with electronic publishing standards. Update SOPs and other job aids for completeness as needed

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