Monday, 20 April 2015

Get cerification and experience together......

https://docs.google.com/forms/d/17B1o8qnDipYPw5gpaNaKygwPG37rGuVb9ZxI7Yny4qA/viewform

Senior Executive -medical Services-RPG Life Sciences limited-Mumbai

CTC : 1,50,000 - 3,50,000 P.A 

Job Description

 
    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 - Pharmacy
PG:M.Pharma - Pharmacy

APPLY HERE

     

Project Co-ordinator-Enem Nostrum Remedies Pvt. Ltd-Mumbai

CTC: 3,00,000 - 5,00,000 P.A 

Job Description

 
1. Preparation of Study documents: Coordinate with the Project Manager (PM), Principal Investigator (PI) and/or Clinical Investigator (CI) for
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.

Desired Candidate Profile

Education-
UG: B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy

APPLY HERE

Business Development Manager - Clinical Research-TECH OBSERVER-Delhi, Mumbai

Job Description

    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.
Atleast 2 yrs. exp. in BD in an CRO working closely with large Pharma Organizations. In depth account knowledge & mapping. Ability to determine method & service that best meets client needs.Good comm. & coordination, team work, perseverance

APPLY HERE

     

Experimental Design-Putting Ideas into design-Clinical Research I Pharmacovigilance I Medical Writing I Regulatory Affairs

https://docs.google.com/forms/d/17B1o8qnDipYPw5gpaNaKygwPG37rGuVb9ZxI7Yny4qA/viewform

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

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

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.

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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

Job Description

 
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

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 

Desired Candidate Profile

Education-
UG: B.Sc - Biology, Microbiology, B.Pharma - Pharmacy, BDS - Dentistry
PG:M.Sc - Any Specialization, Bio-Chemistry, Biology, Microbiology, Nursing, M.Pharma - Pharmacy, PG Diploma - Any Specialization

APPLY HERE

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.
http://www.nih.gov/health/clinicaltrials/basics.htm

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 reports
Education:UG -B.Sc - Any Specialization
PG - M.Sc - Any Specialization

APPLY HERE

Randomization

Randomization is the process by which two or more alternative treatments are assigned to volunteers by chance rather than by choice. This is done to avoid any bias with investigators assigning volunteers to one group or another.  The results of each treatment are compared at specific points during a trial, which may last for years. When one treatment is found superior, the trial is stopped so that the fewest volunteers receive the less beneficial treatment.

http://www.nih.gov/health/clinicaltrials/basics.htm

Pharma Data Entry Associate-Accenture-Chennai

Job Description
Schedule : Full-time

? Organize, manage, and actively carry out as appropriate, local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local agency, local contractual agreements, process documentation and training, inspection preparedness, and any other required country-specific safety activity.
? Carry out all case management activities as appropriate.
? Ensure regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested
? Review processed cases to verify accuracy, consistency, and compliance with process requirements, and review case data for special scenarios
? Ensure complete and timely forwarding of ICSR to Core
? Determine if appropriate case follow-up has been considered. Conduct follow-up activities when needed.
? Consistently apply regulatory requirements and Client policies
? Analyze and monitor activities, define and implement corrective actions, where applicable.
? Develop and maintain expertise of all assigned products, of applicable corporate policies and local regulations, guidelines, Standard Operating Procedures and writing practices, of data entry conventions, and of search functions in the safety database.
? Provide oversight and team mentoring on case handling aspects, data extraction, and analyses.


Desired Profile
? Health Care Professional or equivalent experience preferred ? Minimum 4 years experience in pharmacovigilance and/or data management, clinical care, or clinical or scientific research required ? Experience and skill with medical writing an advantage ? Ability to independently solve routine problems related to case processing and surface issues constructively
Education:UG -B.Sc - Any Specialization
PG - M.Sc - Any Specialization

APPLY HERE

How patients are protected in research?


A retired couple smiling for the camera.


Ethical guidelines

 

The goal of clinical research is to develop knowledge that improves human health or increases understanding of human biology. People who participate in clinical research make it possible for this to occur. The path to finding out if a new drug is safe or effective is to test it on patient volunteers. By placing some people at risk of harm for the good of others, clinical research has the potential to exploit patient volunteers. The purpose of ethical guidelines is both to protect patient volunteers and to preserve the integrity of the science. Ethical guidelines in place today were primarily a response to past research abuses.

Informed consent

Informed consent is the process of learning the key facts about a clinical trial before deciding whether to participate. The process of providing information to participants continues throughout the study. To help someone decide whether to participate, members of the research team explain details of the study. The research team provides an informed consent document, which includes such details about the study as its purpose, duration, required procedures, and who to contact for various purposes. The informed consent document also explains risks and potential benefits.
If the participant decides to enroll in the trial, the informed consent document will be signed. Informed consent is not a contract. Volunteers are free to withdraw from the study at any time.

IRB review

Most, but not all, clinical trials in the United States are approved and monitored by an Institutional Review Board (IRB) in order to ensure that the risks are minimal and are worth any potential benefits. An IRB is an independent committee that consists of physicians, statisticians, and members of the community who ensure that clinical trials are ethical and that the rights of participants are protected. Potential research participants should ask the sponsor or research coordinator whether the research they are considering participating in was reviewed by an IRB.

http://www.nih.gov/health/clinicaltrials/basics.htm

Computer-Aided Drug Design -A process!


In Silico Drug Design Pipeline

Walk - in Interview on 21st April 2015 in Quintiles

Venue  Details:

 Quintiles Technologies Pvt . Ltd
Wing A, Ground Floor, Etamin Block,
Prestige Technology Park II
Sarjapur  Marathahalli, Outer Ring Road,
Bangalore - 560103.
www.quintiles.com
Contact Person: Thenmozhi
Registration Time: 8.00AM

Salary: 2,00,000 - 5,00,000 P.A

Desired Profile

Candidates having 0 - 5 yrs experience in Clinical research domain can walk-in.
Excellent Communication skill is mandatory.


Only First 30 candidates upto 6months experience will be allowed to attend the interview process.
Only First 30 exp candidates (1.5 yrs to 5 yrs) will be allowed to attend the interview process.

Trainee-Clinical Research at Syntel-Pune- (For Freshers Only) - Clinical Research (0-1 Years) - 50 Opening(s)

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 

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

APPLY HERE

Clinical Research Associate- Bio-clinical- QC-Macleods Pharmaceuticals Ltd.

Job Description

 
Male candidates will be Preffered

1. Overseeing all implementation all project specific clinical data as a QC.
2. Coordinate with protocol preparation.
3. Preparation of clinical study reports (CSR), Project summary.
4. ICF Reviewing and obtaining of ICF.
5. Reviewing of Trial Master File.
6. Coordinate with the Volunteer Information Management System (VIMS).
7. Dosing and supervision of Investigational Product.
8. Preparation of clinical reports.
9. Preparation and compilation Case Report Forms (CRF) of pilot and pivotal
10. Thorough with the in-house SOPS, ICR and GCP guidelines.

Desired Candidate Profile

Education-
UG: B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy

APPLY HERE