Job : Clinical Data Reviewer

Job Title             : Clinical Data Reviewer
Company Name : Glaxo Smith Kline
Locations            : Bangalore, India
Qualification and requirement :  

•  Bachelor’s degree in life sciences
• 1-2 yrs work experience in clinical research, data management, regulatory affairs, or other relevant healthcare.
• Logical reasoning capacity
• Good working knowledge of MS office.

Responsibility :

The primary responsibility of the clinical data reviewer (CDR) would be to validate or ‘clean’ encoded clinical data to ensure that no discrepancies, inconsistencies or missing information exist before the data are analyzed. The CDR uses custom-built software tools as well as manual procedures to conduct the validation or ‘data cleaning’. When discrepancies are identified during the validation process, the CDR liaises with the staff at the clinical trial sites to resolve such issues through Data Resolution Queries.

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Job : Glaxo Smith Kline : Manager Clinical Development

Job Title             : Manager - Clinical Development

Company Name : Glaxo Smith Kline

Locations            : Bangalore, India

Qualification and requirement : 

• A medical degree MBBS (post-graduate medical degree is desirable) with ability to independently research questions; sound scientific background required to critically evaluate all scientific aspects of vaccinology / immunology
• 5 – 6 years of relevant experience.
• Proven expertise in clinical research with international Good Clinical Practice Guidelines, basic knowledge of human experimentation laws and regulations.
• Knowledge of Physiology and Anatomy is a must and Vaccinology and immunology is good to have.
• Basic mastery of epidemiological and statistical tools
• Basic technical writing and teaching skills; good stage presence for public speaking
• Basic capability to manage people and budget
• Starting level of leadership of small teams under stress
• Strong technical, statistical and computer skills and the ability to interpret complex clinical data and experimental results.
• Ability to develop network internally and externally to communicate in situations requiring special tact and diplomacy.

Responsibility :

• To participate in the Clinical Development activities for a program or product within the context of the GSK Vaccine Development process in order to ensure the high quality and on-time delivery of all clinical data that will allow world-wide registration in compliance with the clinical development plan, good clinical practices (GCP), and GSK’s standard operating procedures.
• Participate in Clinical Development Activities for a series of studies within a specific program
• Serve as a scientific and management representative for the project (internally /externally)
• Be a core team member of the Clinical Project team
• Actively participate in preparing the clinical part of the files and its registration process
• Provide support to Marketing/Business Development through compound life cycle
• Show active follow-up of the project related Environment

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Job : Glaxo Smith Kline : Study Manager

Job Title             : Global Study Manager
Company Name : Glaxo Smith Kline
Locations            : Bangalore, India
Qualification and requirement :  

• University degree / Post-graduate degree in biological sciences, Genetics, Biotechnology, Microbiology etc.
• At least 5 years experience in clinical trials environment as clinical monitor or clinical research associate or clinical research manager (with monitoring experience)
• Good knowledge and understanding of Study Management roles and activities
• Good knowledge and experience of having used project management tools.
• Strong knowledge ICH-GCP.
• Excellent knowledge of written & spoken English. Additionally knowledge of French is desirable.
• Basic knowledge of project vaccine, Clinical development plan, Target Product Profile for her/his project

Responsibility :

•  The role will focus on evaluation of safety and effectiveness of the drug. Includes Phases I to IV. Some roles might demand patient interaction while others are limited to consulting, benchwork and analysis. The primary responsibilities include the design, planning, organization, analysis and evaluation of studies during clinical trials. Key responsibilities include:
• Managing all types of studies (Phase I to Phase III, standard or non-standard project, collaborative, multi country) according to ICH GCP guidelines and GSK policies and SOP’s to ensure the quality of the study data in order to use them in registration dossiers submissions to regulatory authorities.
• Act as the reference person for all operational/monitoring related issues for his/her studies between the central functions and the local actors of the studies and coordinates the operational aspects of a clinical study from start to end
• Analyze and evaluate the feasibility and consequences of design proposed in regard to procedures, consult other departments (double blind lots…), other teams (DM, …) and with the countries for the monitoring. Ensure necessary specific user-guide is prepared on time (CRF completion guidelines, manual cleaning guidelines, Investigator laboratory manual...). Sign-off of essential documents (protocol, CRF, ICF, primary SR, report)
• Propose, organize and lead monitors meeting, to transfer knowledge and study specific training in order to ensure the highest quality standards. Assess need for and propose co-monitoring visits in countries or do co-monitoring upon request.
• Delegate work to Clinical Trial Assistant and/or Global Study Coordinators of his/her project and coach him/her depending on expertise.
• Actively participate and represent the Global Study Management function, taking into account the need of peers/other projects, in internal process improvements as well as training on their specific taskforce, including presentations at GSM meeting, workshop, SOP session, Investigator/monitors meeting

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Job: Glaxo Smith Kline : Study Coordinator

Job Title             : Global Study Coordinator
Company Name : Glaxo Smith Kline
Locations            : Bangalore, India
Qualification and requirement :

• University degree / Post-graduate degree in biological sciences Genetics, Biotechnology, microbiology etc.
• 3-4 years experience in clinical trials environment as clinical monitor or clinical research associate (with monitoring experience).
• Good knowledge of GCP and clinical trials processes
• Basic knowledge of IT tool
• Excellent English communication skills.

Responsibility : 

• The role will focus on evaluation of safety and effectiveness of the drug. Includes Phases I to IV. Some roles might demand patient interaction while others are limited to consulting, benchwork and analysis. The primary responsibilities include the design, planning, organization, analysis and evaluation of studies during clinical trials.
• Work under supervision of a Global Study Manager (GSM) and participate to the study coordination. (S)He learns the GSM function (on the job training), attend trainings, put into practice information given during trainings, GSM meetings, SOP session… and apply them correctly on the study he/she gives support:
• Acquire good knowledge of ICH-GCP and SOPs, of specific GSK Bio tools for Data collection and management, of archiving processes, etc
• Acquire monitoring experience via co-monitoring visits with GSMs, participate (according to acquired skills) to pre-study, initiation/close-out visits, audit according to growing experience, gain autonomy for monitoring visits. Prepare the monitoring visit report under supervision. Depending on level of experience- perform independently monitoring visits.
• Have contacts in framework of specific tasks/responsibilities with LOC staff monitors and if applicable with investigators. Take over, according to experience level, the contact point role of the GSM for single/multiple country study.

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Books : Pharmacovigilance

Written by an international team of outstanding editors and contributors, Pharmacovigilance, 2nd Edition is the definitive text on this important subject. The new edition has been completely revised and updated to include the latest theoretical and practical aspects of pharmacovigilance including legal issues, drug regulatory requirements, methods of signal generation, reporting schemes and pharmacovigilance in selected system-organ classes.

To download this book Click Here

Pharmacovigilance

Pharmacovigilance is a discipline which is concerned with identifying, validating, quantifying, evaluating and minimizing the adverse effects of medicine thereby increasing the safety of drugs in use. It is a study of drug related adverse effect carried out by pharmaceutical industries to suggest warnings and recommendation for product withdrawal.

IMPORTANCE OF PHARMACOVIGILANCE IN EVERY COUNTRY

There are differences among countries (and even regions within countries) in the occurrence of ADRs and other drug-related problems. This may be due to differences in diseases and prescribing practices, genetics, diet, traditions of the people, drug manufacturing processes used which influence pharmaceutical quality and composition, drug distribution and use including indications, dose and availability.

The use of traditional and complementary drugs (e.g. herbal remedies) may also pose specific toxicological problems, when used alone or in combination with other drugs. Therefore, Pharmacovigilance is needed for detecting ADRs and specifically to combat counterfeit and substandard quality products. ADR monitoring ensures that patients obtain safe and efficacious products.

The Specific Aims of Pharmacovigilance are to

• improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions.
• improve public health and safety in relation to the use of medicines.
• contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use.
• promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.

History of National Pharmacovigilance program

India's Drugs Control Department within the Ministry of Health & Family Welfare initiated the establishment of a nationwide network to build a comprehensive pharmacovigilance data system in 2004. The National Pharmacovigilance Advisory of the Director General of Health Services and the Drug Controller General of India (DCGI), who functions as the member secretary of the Committee. Based at the Central Drugs Standard Control Organization, NPAC was assigned the primary responsibility of setting up the system to monitor the pharmacovigilance programme throughout the country. The National Pharmacovigilance Programme for India is sponsored by the World Health Organization (WHO) and is funded by the World Bank.The NPP is based on the recommendations made in the WHO document titled "Safety Monitoring of Medicinal Products - Guidelines for Setting Up and Running a Pharmacovigilance Centre".

What to report

The programme particularly solicits reports of:

• All adverse events suspected to have been caused by new drugs and ‘drugs of current interest' (List to be published by CDSCO from time to time)
• All suspected drug interactions
• Reactions to any other drugs which are suspected of significantly affecting a patient's management, including reactions suspected of causing:
• Death
• Life-threatening (real risk of dying)
• Hospitalisation (initial or prolonged)
• Disability (significant, persistent or permanent)
• Congenital anomaly
• Required intervention to prevent permanent impairment or damage.

Purpose importance scientific aims of Pharmacovigilance

Recently, its concerns have been widened to include

•  herbals
• traditional and complementary medicines
• blood products
• biologicals
• medical devices
• vaccines

Job: Clinical Research Associate II - Parexel

Job Title             : Clinical Research Associate II

Company Name : Parexel International

Locations            : Bangalore, India

Qualification       : Educated to degree level (biological science, pharmacy or other health related discipline preferred) or equivalent nursing qualification/experience.

Work Profile       :

• Excellent interpersonal, site management and relationship building, verbal and written communication skills including excellent presentation skills.
• Team player with outstanding negotiation and organizational skills.
• Client focused approach to work.
• A flexible attitude with respect to work assignments, new learning and travel (overnight, weekend and occasional international travel may be required).
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
• Willingness to work with multiple supervisors/colleagues in a matrix environment, and to value the importance of team work.
• IT literate ¿ Experience with Microsoft based applications and general knowledge of PC functions.
• Able to take initiative and work independently.
• Sense of urgency in completing assigned tasks.
• Holds a driving license.

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Job: Research Associate - Glenmark Pharmaceuticals

Job Title             : Research Associate

Company Name : Glenmark Pharmaceuticals Ltd

Locations            : Mumbai, India

Qualification       : B.Pharma

Experience          : 1 - 2 Years 

Work Profile       : 

• To plan, undertake and document study audits of the clinical studies to assess the integrity of the data and to determine whether the studies are planned, conducted and reported in compliance to GCP, SOPs and regulatory requirements.
• Review of study protocols.
• To undertake systems audits and document specific audits to determine whether procedures and systems within the Clinical Research Department are adequate, relevant to current operational practices and compliant to GCP, SOPs and regulatory requirements.
• To undertake vendor audits.
• Prepare audit report and forward the audit observation to respective divisions.
• To prepare and reviews of SOPs.
• Responsible for induction and training of new employees and ongoing training of SOPs and GCP/GLP for the existing staff.
• To implement change control and document control procedures.

For more details visit :  http://www.glenmarkpharma.com