Tuesday, 21 April 2015
Clinical Data Manager I-Bengaluru/Bangalore-PPD
ob Description
The objective of a Clinical Data
Manager I is to act as the lead data manager for one or more projects
or to provide support to the lead data manager. CDM I's will lead all
data management activities for individual, limited volume/complexity
studies with mentoring from a manager as required. CDM I's work
independently and efficiently perform, with quality, all data management
activities within an assigned study. CDM I's may mentor junior level
staff on all associated tasks within a study. CDM I's liaise with the
sponsor as required and communicate with management regarding all data
management activities within their studies. Responsibilities include:
Ensures database accuracy according to departmental operating procedures
Performs a QC review of the data and makes corrections to the DM database
Develops data validation manual
Defines and tests databases and data validation system
Represents Data Management in all cross functional meetings relating to the study
Reviews data listings for consistency and accuracy of data
Develops and maintains data management project documentation files
Performs independent reviews of data management deliverables following documented guidelines
Acts as an interdepartmental and sponsor liaison for all DM study activities
Produces project-specific status reports for management and sponsors
Monitors study metrics
Analyzes and resolves discrepancies in data validation or other reports
Education and Experience:
Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RPh, RT)
Minimum 3 years work experience in a professional environment, preferably within a clinical or medical data environment, including 2 years of data management experience
Or a combination of performance, education and prior directly related experience may be considered as equivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job requirements satisfactorily
Education:UG -Any Graduate - Any Specialization, Graduation Not Required
PG - Any Postgraduate - Any Specialization, Post Graduation Not Required
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
Ensures database accuracy according to departmental operating procedures
Performs a QC review of the data and makes corrections to the DM database
Develops data validation manual
Defines and tests databases and data validation system
Represents Data Management in all cross functional meetings relating to the study
Reviews data listings for consistency and accuracy of data
Develops and maintains data management project documentation files
Performs independent reviews of data management deliverables following documented guidelines
Acts as an interdepartmental and sponsor liaison for all DM study activities
Produces project-specific status reports for management and sponsors
Monitors study metrics
Analyzes and resolves discrepancies in data validation or other reports
Education and Experience:
Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RPh, RT)
Minimum 3 years work experience in a professional environment, preferably within a clinical or medical data environment, including 2 years of data management experience
Or a combination of performance, education and prior directly related experience may be considered as equivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job requirements satisfactorily
Desired Profile
Education:UG -Any Graduate - Any Specialization, Graduation Not Required
PG - Any Postgraduate - Any Specialization, Post Graduation Not Required
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
Clinical Research Coordinator-SMO Connect Clinical Research Services Pvt Ltd -Chennai, Coimbatore, Salem
Job description:
1. Maintaining the source documents, CRFs, Investigator Site File and other study related documents according to ICH-GCP guidelines.
2. Completing the eCRF.
3. Maintenance of Investigational Product according to the specific temperature.
4. Preparing for site qualification visits, initiation visits, monitoring visits and site close out visits.
5. Organizing ethics committee meetings.
6. Completing the review forms and submitting all study related documents to EC.
7. Coordinating with the local labs, central labs.
8. Assistance in Safety Reporting within the required timelines.
9. Assistance in patient selection and recruitment. .
10. Assistance in Informed Consent Process.
PG:M.Sc - Any Specialization, Microbiology, M.Tech - Any Specialization, Bio-Chemistry/Bio-Technology
1. Maintaining the source documents, CRFs, Investigator Site File and other study related documents according to ICH-GCP guidelines.
2. Completing the eCRF.
3. Maintenance of Investigational Product according to the specific temperature.
4. Preparing for site qualification visits, initiation visits, monitoring visits and site close out visits.
5. Organizing ethics committee meetings.
6. Completing the review forms and submitting all study related documents to EC.
7. Coordinating with the local labs, central labs.
8. Assistance in Safety Reporting within the required timelines.
9. Assistance in patient selection and recruitment. .
10. Assistance in Informed Consent Process.
Desired Candidate Profile
Education-
UG: B.Tech/B.E. - Any Specialization, Bio-Chemistry/Bio-Technology, B.Sc - Any Specialization, MicrobiologyPG:M.Sc - Any Specialization, Microbiology, M.Tech - Any Specialization, Bio-Chemistry/Bio-Technology
APPLY HERE
Post of Clinical Data Coordinator- Post of Clinical Data Coordinator i Clin Research Solution Pvt Ltd -Bengaluru/Bangalore, Chennai, Hyderabad / Secunderabad
Individual Case Safety Report Processing,
End to End CDM activities
Relevant experience in ClinicalDataManagement (Mandatory Rave/OC)
Perform datamanagement activities on the assigned project in a timely and efficient manner
PG:M.Tech - Any Specialization, Bio-Chemistry/Bio-Technology, Computers, MCA - Computers, M.Sc - Any Specialization, Bio-Chemistry, Biology, M.Pharma - Pharmacy, M.S/M.D - Any Specialization, MVSC - Veterinary Science, M.A - Any Specialization
End to End CDM activities
Relevant experience in ClinicalDataManagement (Mandatory Rave/OC)
Perform datamanagement activities on the assigned project in a timely and efficient manner
Desired Candidate Profile
Education-
UG: B.Tech/B.E.
- Any Specialization, Bio-Chemistry/Bio-Technology, Computers, B.Sc -
Any Specialization, Bio-Chemistry, Biology, Computers, Microbiology,
B.Pharma - Pharmacy, BDS - Dentistry, BHM - Hotel Management, MBBS - Medicine, BVSC - Veterinary Science, BCA - Computers, B.A - Any SpecializationPG:M.Tech - Any Specialization, Bio-Chemistry/Bio-Technology, Computers, MCA - Computers, M.Sc - Any Specialization, Bio-Chemistry, Biology, M.Pharma - Pharmacy, M.S/M.D - Any Specialization, MVSC - Veterinary Science, M.A - Any Specialization
APPLY HERE
Trainee (For Freshers Only) - Clinical Research (0-1 Years) - 50 Opening(s)-Pune
Job Requirements:
Candidates with diploma/course in Clinical Research will be preferred.
Clinical Research subject knowledge
Good Communication Skills
MS Office knowledge
Willingness to work in Night Shifts
Freshers only
Walkin details:
Date-22nd April to 23rd April , Starting Time: 10 AM
Contact person : Vishal Salve
020-30615000
Interview Location : Syntel Ltd,Talawade Softeware Technology Park, Talawade, Pune
UG - B.Tech/B.E. - Agriculture, Bio-Chemistry/Bio-Technology, B.Sc - Agriculture, Anthropology, Bio-Chemistry, Biology, Botany, Chemistry, Dairy Technology, Environmental science, Food Technology, Microbiology, Nursing, Zoology, General, B.Pharma - Pharmacy, BDS - Dentistry, BVSC - Veterinary Science
PG - M.Sc - Agriculture, Anthropology, Bio-Chemistry, Biology, Botany, Chemistry, Dairy Technology, Environmental science, Food Technology, Microbiology, Nursing, Zoology, M.Tech - Agriculture, Bio-Chemistry/Bio-Technology, M.Pharma - Pharmacy
Candidates with diploma/course in Clinical Research will be preferred.
Clinical Research subject knowledge
Good Communication Skills
MS Office knowledge
Willingness to work in Night Shifts
Freshers only
Walkin details:
Date-22nd April to 23rd April , Starting Time: 10 AM
Contact person : Vishal Salve
020-30615000
Interview Location : Syntel Ltd,Talawade Softeware Technology Park, Talawade, Pune
UG - B.Tech/B.E. - Agriculture, Bio-Chemistry/Bio-Technology, B.Sc - Agriculture, Anthropology, Bio-Chemistry, Biology, Botany, Chemistry, Dairy Technology, Environmental science, Food Technology, Microbiology, Nursing, Zoology, General, B.Pharma - Pharmacy, BDS - Dentistry, BVSC - Veterinary Science
PG - M.Sc - Agriculture, Anthropology, Bio-Chemistry, Biology, Botany, Chemistry, Dairy Technology, Environmental science, Food Technology, Microbiology, Nursing, Zoology, M.Tech - Agriculture, Bio-Chemistry/Bio-Technology, M.Pharma - Pharmacy
Sr. Pharmacovigilance Physician-Quintiles-Bengaluru/Bangalore
PURPOSE Apply knowledge and expertise including complex decision making activities to review, assess and process Lifecycle Safety data
and information across all service lines. Recognized as specialist in
one or more areas. Provide oversight on small to medium service
operational projects and act as mentor to junior members of staff.
RESPONSIBILITIES
Receive, triage, review and process Lifecycle safety operational data from various sources on time, within budget and quality standards. Perform data entry for tracking and Lifecycle safety databases, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines. Pre-process material for endpoint committee or core laboratory adjudication. Preparation of material for submission.
Assess Lifecycle safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement. Liaise with local Quintiles offices to facilitate expedited reporting. Liaise with systems manager for regulatory tracking requirements and electronic reporting.
Contribute knowledge and expertise to or lead assigned deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.
Receive and document incoming telephone calls, faxes or emails from investigative sites or other sources reporting operational data.
Process Lifecycle safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements.
Build a positive, collaborative team environment with Lifecycle safety team members, lead by example, provide training and mentoring for less experienced team members and operations staff, assist Operations with appropriate allocation of resource.
Provide oversight role and have a good understanding of operational team on status, metrics, productivity and initiatives.
Provide and impart technical and process information to Lifecycle Safety Management (LSM) and members of operational team on project specific issues.
Provide oversight and maintain a thorough understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects; set up and maintain project files, standards, templates, electronic forums, databases and workflow.
Establish and maintain effective team project service operations communications i.e. provide regular feedback to operations team manager and Customer Delivery manager (CDM) on project metrics, out of scope work challenges/issues and successes; feedback effective project performance to junior members of team.
Liaise with LSM contact in proactively identifying issues and proposing solutions, providing them with technical support, reports, metrics, statuses, identifying SOW changes and potential change orders ,delegating client requests and installation of new initiatives.
Ensure compliance to Quintiles high quality standards and works with LSM constructively in a matrix framework to achieve project and customer deliverables.
Participate in training across Lifecycle safety process service offerings, participate in working groups as applicable in implementation of new initiatives, identification and implementation of process efficiencies.
Liaise confidently with different functional team members, e.g. project management, clinical, data management, health care professionals e.g. investigators, medical monitors, site coordinators and designees to address operational project issues.
Contribute to achieving productivity utilization and realization metrics.
Read and acknowledge all necessary Quintiles standard operating procedures (SOPs) and customer SOPs as required.
Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable.
Perform other duties as assigned.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
In depth knowledge of Lifecycle safety processes and willingness and aptitude to learn new skills across Lifecycle safety service lines.
In depth knowledge and understanding of applicable global, regional, local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, SOPs.
Proven ability to meet strict deadlines; manage competing priorities.
Demonstrate effective project management and leadership skills.
Sound judgment; independent thinking and decision making skills.
Demonstrate a flexible and receptive approach to changing demands.
Proven ability to work independently and autonomously with policies and practices.
Effective mentoring and coaching skills.
Excellent attention to detail and accuracy maintaining consistently high quality standards.
Excellent organizational skills and time management skills.
Excellent written/verbal communication and report writing skills.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Ability to work effectively on multiple projects simultaneously organize own workload and effectively manage competing priorities.
RESPONSIBILITIES
Receive, triage, review and process Lifecycle safety operational data from various sources on time, within budget and quality standards. Perform data entry for tracking and Lifecycle safety databases, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines. Pre-process material for endpoint committee or core laboratory adjudication. Preparation of material for submission.
Assess Lifecycle safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement. Liaise with local Quintiles offices to facilitate expedited reporting. Liaise with systems manager for regulatory tracking requirements and electronic reporting.
Contribute knowledge and expertise to or lead assigned deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.
Receive and document incoming telephone calls, faxes or emails from investigative sites or other sources reporting operational data.
Process Lifecycle safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements.
Build a positive, collaborative team environment with Lifecycle safety team members, lead by example, provide training and mentoring for less experienced team members and operations staff, assist Operations with appropriate allocation of resource.
Provide oversight role and have a good understanding of operational team on status, metrics, productivity and initiatives.
Provide and impart technical and process information to Lifecycle Safety Management (LSM) and members of operational team on project specific issues.
Provide oversight and maintain a thorough understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects; set up and maintain project files, standards, templates, electronic forums, databases and workflow.
Establish and maintain effective team project service operations communications i.e. provide regular feedback to operations team manager and Customer Delivery manager (CDM) on project metrics, out of scope work challenges/issues and successes; feedback effective project performance to junior members of team.
Liaise with LSM contact in proactively identifying issues and proposing solutions, providing them with technical support, reports, metrics, statuses, identifying SOW changes and potential change orders ,delegating client requests and installation of new initiatives.
Ensure compliance to Quintiles high quality standards and works with LSM constructively in a matrix framework to achieve project and customer deliverables.
Participate in training across Lifecycle safety process service offerings, participate in working groups as applicable in implementation of new initiatives, identification and implementation of process efficiencies.
Liaise confidently with different functional team members, e.g. project management, clinical, data management, health care professionals e.g. investigators, medical monitors, site coordinators and designees to address operational project issues.
Contribute to achieving productivity utilization and realization metrics.
Read and acknowledge all necessary Quintiles standard operating procedures (SOPs) and customer SOPs as required.
Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable.
Perform other duties as assigned.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
In depth knowledge of Lifecycle safety processes and willingness and aptitude to learn new skills across Lifecycle safety service lines.
In depth knowledge and understanding of applicable global, regional, local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, SOPs.
Proven ability to meet strict deadlines; manage competing priorities.
Demonstrate effective project management and leadership skills.
Sound judgment; independent thinking and decision making skills.
Demonstrate a flexible and receptive approach to changing demands.
Proven ability to work independently and autonomously with policies and practices.
Effective mentoring and coaching skills.
Excellent attention to detail and accuracy maintaining consistently high quality standards.
Excellent organizational skills and time management skills.
Excellent written/verbal communication and report writing skills.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Ability to work effectively on multiple projects simultaneously organize own workload and effectively manage competing priorities.
APPLY HERE
Safety Associate I-Pune, Hyderabad / Secunderabad-inVentiv Health
Job Description
Responsibilities Review serious adverse experience (SAE) information received from Investigator sites and adverse experiences (AEs) from post marketing sources for completeness and regulatory compliance
Prepare safety data reports for submissions to clients
Prepare expedited Safety Reports for submission to Regulatory Authorities
Assist in representation of Global Safety and Pharmacovigilance group at project team and client meetings
Communicate with Clinical Operations and clients to ensure compliance with safety and Pharmacovigilance SOPs
Assist in compilation of regulatory submissions, i.e., Annual Reports Periodic Safety Update Reports
Assist the safety lead for projects; to include set up , project management, client liaison
Perform literature searches
Assist with SAE reconciliations
Desired Profile
RequirementsBachelors Degree in a life science or nursing; or RN diploma; in Lieu of degree a total of four years relevant experience may be considered.
One year relevant experience in Safety/Pharmacovigilance required which may include up to 2 years of data management, CRA, clinical practice (RN, RPN). Health authority of study coordinator experience
Good Verbal and written communication skills
Good Knowledge of ICH guidelines and regulations relating to Safety Reporting
Education:UG -Diploma - Any Specialization, B.Sc - Any Specialization, Nursing
PG - Any Postgraduate
APPLY HERE
Monday, 20 April 2015
Senior Executive -medical Services-RPG Life Sciences limited-Mumbai
CTC : 1,50,000 - 3,50,000 P.A
PG:M.Pharma - Pharmacy
-
Medico Marketing - literature search, customized presentations,
product launch preparations, inhouse publication, preparation of
scientific PPTs
Clinicalresearch - co-ordination , monitoring of BE studies , post marketing studies, animal studies
Desired Candidate Profile
Education-
UG: B.Pharma - PharmacyPG:M.Pharma - Pharmacy
APPLY HERE
Project Co-ordinator-Enem Nostrum Remedies Pvt. Ltd-Mumbai
CTC: 3,00,000 - 5,00,000 P.A
Preparation of the study protocol, CRFs and other working documents.
Prepare Informed Consent Documents (ICD) in English and coordinate for translation into local language(s) and its back translation into English, if applicable.
Prepare a dossier for submission to the regulatory and Independent Ethics Committee (IEC).
2. Ensure following are available before study execution:
No Objection Certificate (NOC) from regulatory authority
Approval letter from the IEC
Availability of Investigational Product (IPs) at site
3. Pharmacy:
Handling of Investigational products (Receipt, Storage, Accountability).
Compounding and dispensing of Invitational Products as per Randomization schedule and Protocol.
Coordinate with Principal Investigator for maintaining accountability of investigational product up to retention period.
Management of Pharmacy.
4. Study Planning and Execution:
Coordinate with the Principal Investigator / Project Manager for planning of study schedule.
Prepare Trial master file as per the SOP or Sponsors requirement.
Prepare the protocol summary for the protocol training.
Ensure that the protocol training is provided to the concerned study personnel, before the start of study related activities.
Coordinate with screening team for subject recruitment and screening.
Coordinate with Dietician to ensure that the meal menu is prepared as per protocol requirements and submitted to caterer well in advance.
Ensure that all the volunteers reported for ICD presentation are fit for participation in the study as per the respective protocol.
Coordinate with Principal Investigator and / or Clinical Investigator and / or clinicalresearch physician for ICD presentation to subjects
Coordinate with clinical staff for admission, discharge, Meal distribution, dosing/dosing supervision and monitoring the subjects during study for restriction compliance.
Ensure that the biological samples are collected, processed, stored and transferred as mentioned in the protocol. Review all forms and log formats related to the processing, storing and transferring of the samples.
Ensure that the adverse event/serious adverse event reported during the study are adequately handled.
Monitor the study to ensure that the study is conducted as per approved Protocol, International Conference on Harmonization-Good Clinical Practice (ICH-GCP) and in house Standard Operating Procedures (SOP).
Collect and review the raw data from group leaders (e.g. Nurse, Phlebotomist, CRP etc) and handover those to CQMs for their review.
Coordinate with the CQM for submission of raw data and draft project report to the QA department as per the predefine timeline.
Coordinate with the CQM and QA for audit reports and compilation.
Coordinate with Report writer and Project Manager for preparation of the final report
Coordinate with the PI/CI and PM for submission of CRFs to the Data Management and resolve all the data queries, if applicable.
5. Regulatory/Client Audit or Visit:
Ensure all the study documents are available as per the TMF checklist for audit.
Ensure the respective clinic/facility is ready for audit/visit.
6. Archival:
Coordinate with PM and CQM for Archival of study documents (e.g Protocol, project report, study raw data and other documents) and mail /telephone communication as per the procedure.
7. Others:
Identify protocol deviations, SOP deviations, file notes in consultation with the PI/CI/PM.
Coordinate with PM / Head CPU for preparation of new SOPs as well as revising current SOPs to upgrade the system.
Perform any other duties as assigned by Principal Investigator / Project Manager.
PG:M.Pharma - Pharmacy
Job Description
1. Preparation of Study documents: Coordinate with the Project Manager (PM), Principal Investigator (PI) and/or Clinical Investigator (CI) forPrepare Informed Consent Documents (ICD) in English and coordinate for translation into local language(s) and its back translation into English, if applicable.
Prepare a dossier for submission to the regulatory and Independent Ethics Committee (IEC).
2. Ensure following are available before study execution:
No Objection Certificate (NOC) from regulatory authority
Approval letter from the IEC
Availability of Investigational Product (IPs) at site
3. Pharmacy:
Handling of Investigational products (Receipt, Storage, Accountability).
Compounding and dispensing of Invitational Products as per Randomization schedule and Protocol.
Coordinate with Principal Investigator for maintaining accountability of investigational product up to retention period.
Management of Pharmacy.
4. Study Planning and Execution:
Coordinate with the Principal Investigator / Project Manager for planning of study schedule.
Prepare Trial master file as per the SOP or Sponsors requirement.
Prepare the protocol summary for the protocol training.
Ensure that the protocol training is provided to the concerned study personnel, before the start of study related activities.
Coordinate with screening team for subject recruitment and screening.
Coordinate with Dietician to ensure that the meal menu is prepared as per protocol requirements and submitted to caterer well in advance.
Ensure that all the volunteers reported for ICD presentation are fit for participation in the study as per the respective protocol.
Coordinate with Principal Investigator and / or Clinical Investigator and / or clinicalresearch physician for ICD presentation to subjects
Coordinate with clinical staff for admission, discharge, Meal distribution, dosing/dosing supervision and monitoring the subjects during study for restriction compliance.
Ensure that the biological samples are collected, processed, stored and transferred as mentioned in the protocol. Review all forms and log formats related to the processing, storing and transferring of the samples.
Ensure that the adverse event/serious adverse event reported during the study are adequately handled.
Monitor the study to ensure that the study is conducted as per approved Protocol, International Conference on Harmonization-Good Clinical Practice (ICH-GCP) and in house Standard Operating Procedures (SOP).
Collect and review the raw data from group leaders (e.g. Nurse, Phlebotomist, CRP etc) and handover those to CQMs for their review.
Coordinate with the CQM for submission of raw data and draft project report to the QA department as per the predefine timeline.
Coordinate with the CQM and QA for audit reports and compilation.
Coordinate with Report writer and Project Manager for preparation of the final report
Coordinate with the PI/CI and PM for submission of CRFs to the Data Management and resolve all the data queries, if applicable.
5. Regulatory/Client Audit or Visit:
Ensure all the study documents are available as per the TMF checklist for audit.
Ensure the respective clinic/facility is ready for audit/visit.
6. Archival:
Coordinate with PM and CQM for Archival of study documents (e.g Protocol, project report, study raw data and other documents) and mail /telephone communication as per the procedure.
7. Others:
Identify protocol deviations, SOP deviations, file notes in consultation with the PI/CI/PM.
Coordinate with PM / Head CPU for preparation of new SOPs as well as revising current SOPs to upgrade the system.
Perform any other duties as assigned by Principal Investigator / Project Manager.
Desired Candidate Profile
Education-
UG: B.Pharma - PharmacyPG:M.Pharma - Pharmacy
APPLY HERE
Business Development Manager - Clinical Research-TECH OBSERVER-Delhi, Mumbai
-
Establish & maintain positive,profitable relationship with key
personnel in assigned client account to generate business. contributing
to completion of projects in time,generating leads,executing contracts,
RFP/RFI response.
APPLY HERE
Sunday, 19 April 2015
FDA Approval
The FDA approval of Farydak was based on a randomized, double-blind, placebo-controlled, multicenter study in patients with relapsed multiple myeloma who had received 1 to 3 prior lines of therapy. A total of 768 subjects received bortezomib (1.3 mg/m2 injected intravenously) with dexamethasone (20 mg) in addition to Farydak 20 mg (or placebo), taken orally every other day, for 3 doses per week in Weeks 1 and 2 of each 21-day cycle. Treatment was administered for a maximum of 16 cycles (48 weeks). The primary endpoint was progression-free survival (PFS), using modified European Bone Marrow Transplant Group (EBMT) criteria, as assessed by the investigators. In the overall trial population, the median PFS was 12 months in the Farydak, bortezomib, dexamethasone arm and 8.1 months in the placebo, bortezomib, dexamethasone arm. At the time of interim analysis, overall survival was not statistically different between arms. The approval of Farydak was based upon the efficacy and safety in a prespecified subgroup analysis of 193 patients who had received prior treatment with both bortezomib and an immunomodulatory agent and a median of 2 prior therapies as the benefit:risk appeared to be greater in this more heavily pretreated population than in the overall trial population. Of these 193 patients, 76% of them had received ≥2 prior lines of therapy. The median PFS was 10.6 months in the Farydak, bortezomib, and dexamethasone arm and 5.8 months in the placebo, bortezomib, and dexamethasone arm.
More about it
The FDA approval of Farydak was based on a randomized, double-blind, placebo-controlled, multicenter study in patients with relapsed multiple myeloma who had received 1 to 3 prior lines of therapy. A total of 768 subjects received bortezomib (1.3 mg/m2 injected intravenously) with dexamethasone (20 mg) in addition to Farydak 20 mg (or placebo), taken orally every other day, for 3 doses per week in Weeks 1 and 2 of each 21-day cycle. Treatment was administered for a maximum of 16 cycles (48 weeks). The primary endpoint was progression-free survival (PFS), using modified European Bone Marrow Transplant Group (EBMT) criteria, as assessed by the investigators. In the overall trial population, the median PFS was 12 months in the Farydak, bortezomib, dexamethasone arm and 8.1 months in the placebo, bortezomib, dexamethasone arm. At the time of interim analysis, overall survival was not statistically different between arms. The approval of Farydak was based upon the efficacy and safety in a prespecified subgroup analysis of 193 patients who had received prior treatment with both bortezomib and an immunomodulatory agent and a median of 2 prior therapies as the benefit:risk appeared to be greater in this more heavily pretreated population than in the overall trial population. Of these 193 patients, 76% of them had received ≥2 prior lines of therapy. The median PFS was 10.6 months in the Farydak, bortezomib, and dexamethasone arm and 5.8 months in the placebo, bortezomib, and dexamethasone arm.
More about it
Join as Intern in Clinical Research I Pharmacovigilance I Medical Writing I Regulatory Affairs projects
Internship in drug development projects for Clinical Research & Management I Pharmacovigilance I Regulatory Affairs I Medical Writing for the following types of project- Multiple Sclerosis, Angina Pectoris, Pain disorders, Nero-degenerative studies APPLY HERE......
http://badasscontent.com/jobenter3
Farydak (panobinostat) for treatment of patients with multiple myeloma
FDA Approval
The FDA approval of Farydak was based on a randomized, double-blind, placebo-controlled, multicenter study in patients with relapsed multiple myeloma who had received 1 to 3 prior lines of therapy. A total of 768 subjects received bortezomib (1.3 mg/m2 injected intravenously) with dexamethasone (20 mg) in addition to Farydak 20 mg (or placebo), taken orally every other day, for 3 doses per week in Weeks 1 and 2 of each 21-day cycle. Treatment was administered for a maximum of 16 cycles (48 weeks). The primary endpoint was progression-free survival (PFS), using modified European Bone Marrow Transplant Group (EBMT) criteria, as assessed by the investigators. In the overall trial population, the median PFS was 12 months in the Farydak, bortezomib, dexamethasone arm and 8.1 months in the placebo, bortezomib, dexamethasone arm. At the time of interim analysis, overall survival was not statistically different between arms. The approval of Farydak was based upon the efficacy and safety in a prespecified subgroup analysis of 193 patients who had received prior treatment with both bortezomib and an immunomodulatory agent and a median of 2 prior therapies as the benefit:risk appeared to be greater in this more heavily pretreated population than in the overall trial population. Of these 193 patients, 76% of them had received ≥2 prior lines of therapy. The median PFS was 10.6 months in the Farydak, bortezomib, and dexamethasone arm and 5.8 months in the placebo, bortezomib, and dexamethasone arm.
More about it
The FDA approval of Farydak was based on a randomized, double-blind, placebo-controlled, multicenter study in patients with relapsed multiple myeloma who had received 1 to 3 prior lines of therapy. A total of 768 subjects received bortezomib (1.3 mg/m2 injected intravenously) with dexamethasone (20 mg) in addition to Farydak 20 mg (or placebo), taken orally every other day, for 3 doses per week in Weeks 1 and 2 of each 21-day cycle. Treatment was administered for a maximum of 16 cycles (48 weeks). The primary endpoint was progression-free survival (PFS), using modified European Bone Marrow Transplant Group (EBMT) criteria, as assessed by the investigators. In the overall trial population, the median PFS was 12 months in the Farydak, bortezomib, dexamethasone arm and 8.1 months in the placebo, bortezomib, dexamethasone arm. At the time of interim analysis, overall survival was not statistically different between arms. The approval of Farydak was based upon the efficacy and safety in a prespecified subgroup analysis of 193 patients who had received prior treatment with both bortezomib and an immunomodulatory agent and a median of 2 prior therapies as the benefit:risk appeared to be greater in this more heavily pretreated population than in the overall trial population. Of these 193 patients, 76% of them had received ≥2 prior lines of therapy. The median PFS was 10.6 months in the Farydak, bortezomib, and dexamethasone arm and 5.8 months in the placebo, bortezomib, and dexamethasone arm.
More about it
Saturday, 18 April 2015
Placebo
A placebo is a pill or liquid that looks like the new treatment but does not have any treatment value from active ingredients.
Wipro | Hiring for Group Leader for Pharmacovigiliance-Delhi
WIPRO BPO
HIRING FOR GROUP LEADER ( Pharmacovigiliance)
ROLES & RESPONSIBILTY :
o Complete case processing in ARISG (Adverse reaction information system global) database.
o Pharmacovigiliance process operations management.
o Proven aptitude to analyze and translate complex customer requirements and business problems and design/implement innovative custom solutions.
o Responsible for developing training materials and workflow related to Medical Writing and Pharmacovigiliance.
EDUCATION & EXPERIENCE:
MBBS / PHD with 1-3 years experience.
CANDIDATE SHOULD BE COMFORTABLE WORKING IN ROTATIONAL (24*7) SHIFTS.
JOB LOCATION:
New Delhi ( Sarita Vihar)
If Interested Please share your resume at Kanika.sharma8@wipro.com
HIRING FOR GROUP LEADER ( Pharmacovigiliance)
ROLES & RESPONSIBILTY :
o Complete case processing in ARISG (Adverse reaction information system global) database.
o Pharmacovigiliance process operations management.
o Proven aptitude to analyze and translate complex customer requirements and business problems and design/implement innovative custom solutions.
o Responsible for developing training materials and workflow related to Medical Writing and Pharmacovigiliance.
EDUCATION & EXPERIENCE:
MBBS / PHD with 1-3 years experience.
CANDIDATE SHOULD BE COMFORTABLE WORKING IN ROTATIONAL (24*7) SHIFTS.
JOB LOCATION:
New Delhi ( Sarita Vihar)
If Interested Please share your resume at Kanika.sharma8@wipro.com
Clinical Research Coordinator-0-1years-Bengaluru/Bangalore, Hyderabad / Secunderabad, Mumbai-Openings: 4
Salary: 1,75,000 - 2,00,000 P.A. Best in the Industry
PG:M.Sc - Any Specialization, Bio-Chemistry, Biology, Microbiology, Nursing, M.Pharma - Pharmacy, PG Diploma - Any Specialization
Desired Candidate Profile
Education-
UG: B.Sc - Biology, Microbiology, B.Pharma - Pharmacy, BDS - DentistryPG:M.Sc - Any Specialization, Bio-Chemistry, Biology, Microbiology, Nursing, M.Pharma - Pharmacy, PG Diploma - Any Specialization
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Types of clinical trials in Drug Development process
There are different types of clinical trials.
- Natural history studies provide valuable information about how disease and health progress.
- Prevention trials look for better ways to prevent a disease in people who have never had the disease or to prevent the disease from returning. Better approaches may include medicines, vaccines, or lifestyle changes, among other things.
- Screening trials test the best way to detect certain diseases or health conditions.
- Diagnostic trials determine better tests or procedures for diagnosing a particular disease or condition.
- Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
- Quality of life trials (or supportive care trials) explore and measure ways to improve the comfort and quality of life of people with a chronic illness.
NH Case Processing Associate-Accenture-Chennai
Job Description
Schedule : Full-time Perform single case medical assessment, including the determination of seriousness, expectedness / listedness /labeledness, and causality of adverse events in compliance with current regulations, internal and external guidance documents, Standard Operating Procedures, Safety Job Aids, the Argus User Reference Guide and case processing/coding conventions.
Maintain the timely submission of expedited reports.
Support the achievement of the Therapeutic Areas case processing performance timelines. Identify cases that meet SUSAR reporting criteria, prepare the SUSAR narrative, perform risk assessment, initiate the unblinding process (as appropriate), and make the report available for distribution.
Identify and evaluate safety signals based on individual cases and cumulative data assessment and by using other signal detection systems. Provide data-driven decisions and communicate these findings proactively and effectively to the key stakeholders.
Partner with Worldwide Safety Strategy and with other Worldwide Safety and Regulatory Safety Operations functional groups to monitor the safety profile of assigned products.
Actively participate in Risk Management Committees and other risk management activities for assigned therapeutic areas. Perform product safety reviews as appropriate.
Provide medical safety input as appropriate to Clinical Development Teams regarding expectedness /listedness/labeledness, causality, and data reconciliation.
As appropriate, provide medical safety input, and review or draft sections of response documents to health authority inquiries.
Work with the Therapeutic Area Head to proactively and effectively communicate product safety issues and proposed solutions to PSSR management and to the Office of the EU Qualified Person.
Desired Profile
Medical Degree from an accredited
institution Minimum of two years of experience as an MD in clinical
practice Minimum of two years of relevant experience in
pharmacovigilance, clinical research or related field
Pharmaceutical industry experience preferred Working knowledge of
international regulations and guidance documents as related to worldwide
reporting requirements, preparation of clinical trial safety
assessments, and regulatory submissions including the preparation of
aggregate reportsEducation:UG -B.Sc - Any Specialization
PG - M.Sc - Any Specialization
APPLY HERE
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