Evidence Based Medicine - Pharmacist for Better Clinical Practice

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Evidence-based medicine (EBM) is a process of systematically reviewing, appraising and using clinical research findings to aid the delivery of optimum clinical care to patients. In 1990's the term Evidence Based Medicine was introduced by "David Sackett and Gordon Guyatt". EBM includes the production of evidence through research and scientific review; production of evidence based clinical guidelines; Implementation of evidence-based, cost-effective practice through education and management; Strategical calculation of outcomes through evaluation of compliance. 

The Cochrane Library serves as the most valuable single access point with high-quality, independent evidence to inform healthcare decision-making. The various databases of Cochrane library includes: 

1. The Cochrane Database of Systematic Reviews : 3625 reviews and 1921 protocols.
2. The Database of Abstracts of Reviews of Effects (DARE) : 9025 systemic reviews.
3. The Cochrane Central Register of Controlled Trials :  550,000 studies.
4. The Health Technology Assessment Database : 7,528 health technology assessments.
5. The National Health Service (NHS) Economic Evaluation Database : 24,451 critical appraisals.

SIGN classification of grading Evidence: 

• 1++ High-quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias.
• 1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias.
• 1– Meta-analyses, systematic reviews, or RCTs with a high risk of bias.
• 2++ High-quality systematic reviews of case-control or cohort studies High-quality case-control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal.
• 2+ Well-conducted case-control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal.
• 2– Case-control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal.
• 3 Non-analytic studies; for example, case reports, case series.
• 4 Expert opinion.

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Views of Pharmacist: 

Being an active part of health care system every pharmacist strives to provide the best possible care for patients. However, it is not always possible to translate the current developments into clinical practice. Although pharmacotherapy can be beneficial in all the patients, it can also lead to drug-related problems (DRPs), including untreated indications, drug use without an indication, improper drug selection, subtherapeutic dosage, overdosage, medication error, medication nonadherence, drug interactions, adverse drug reactions, adverse drug withdrawal events, and therapeutic failure. Clinical pharmacy services have a positive impact on drug-related problems and health outcomes reducing the burden and improving the quality of life of patient through Evidence based practice.

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Regards,

Deepak Kumar Bandari,

Pharm.D Intern,

Vaagdevi College of Pharmacy - India

Elsevier Student Ambassador - South Asia

Kudos to Pharm.D graduates for grabbing Government Jobs : List

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Congratulations to all the Pharm.D graduates who got placed under Pharmacovigilance programme of India (PvPI) by Indian Pharmacopoeia Commission (IPC).

Here is the Result for the post of Technical Associates under PvPI from the personal interview held on 29th, 30th, 31st July and 01st August 2015 at IPC. 

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Note: It is the list of selected candidates from both Pharm.D and M.Pharm

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Regards,

Deepak Kumar Bandari,

Pharm.D Intern,

Vaagdevi College of Pharmacy - India

Elsevier Student Ambassador - South Asia

Patent Analyst : Research and Development - Novozymes

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Patent Analyst, Intellectual Property, Research & Development

Location: Bengaluru, India

Last Date: 18- August 2015

Company Profile:

At Novozymes, we work in close partnership with our customers to make an impact and help create a better world. We use science to advance industries, and as part of R&D, you will create and develop the biological answers that will pave the way for a brighter future.

You’ll be part of a dynamic international team of patent analysts and attorneys based in Bengaluru and other locations across the world, and will assist in delivery of quality results in search and analysis domain within intellectual property. 

You thrive in a fast-paced learning environment and are as comfortable with working in a team by coordinating with other analysts and attorneys on a day-to-day basis as you are with working independently with attention to detail - interpreting data, performing analysis and presenting results. For the right individual, this is a fantastic career opportunity with potential for personal and professional development.

Requirements:

1. Have a Master’s degree with relevant experience within biotechnology, biochemistry, or molecular biology, possibly supplemented with a PhD
2. You should have 2-4 years of experience working as a Patent analyst or in a similar role – especially in making excellent searches and informative reports
3. Have expertise in working with Freedom to Operate Analysis (FOA) and clearance searches (added advantage)
4. Be a team player with strong analytical, documentation and communication skills
5. Be able to work independently and take ownership
6. Be creative, take initiative, learn fast, display result orientation and work with challenging deadlines

How to apply: Click here

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Regards,

Deepak Kumar Bandari,

Pharm.D Intern,

Vaagdevi College of Pharmacy - India

Elsevier Student Ambassador - South Asia

Clinical Trial Monitor - Phase Studies : Manipal Acunova Ltd

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Clinical Trial Monitor - Phase Studies : Manipal Acunova Ltd

Role : Clinical Research Associate / Scientist

Number of Openings : 03

Experience required : 1-4 years 

Location : Bangalore

Ecron Acunova provides end-to-end services for Phase I-IV clinical research, including Clinical Trial Management, Clinical Data Management, PK/PD services and Central Lab. Ecron Acunova has research facilities in Asia as well as an established presence in various parts of Europe and the United States. We offer clinical development services to the pharmaceutical, biotechnology, nutritional, device and medical diagnostics industries. Our service quality, therapeutic expertise and global reach have allowed us to grow rapidly, building a list of demanding clients. We provide an attractive package of services coupled with the ability to rapidly conduct clinical trials utilizing a world class delivery platform.

Job profile: 

The responsibility is to perform all clinical monitoring aspects of designated projects in accordance with applicable SOP and regulations. Responsibilities include performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, and data collection), collecting regulatory documentation (when required), performing qualification, initiation, monitoring and termination of investigational sites in accordance with ICH-GCP guidelines.

1. Preparation of Site feasibility questionnaire, conducting the feasibility and reporting to PM.
2. Preparation, conduct and reporting of site selection visits.
3. Negotiation & obtaining Investigator agreement on site budget, payment to the sites.
4. Development/Local adaptation of study specific documents (ICF, CRF prints, Study logs), translations of the documents.
5. Procuring essential documents from sites, their QC and filing in a timely manner and updating project tracker or sending the documents to PA for filing in a timely manner.
6. Maintenance of TMF and Site specific file.
7. Scanning & uploading documents into shared drive.
8. Transmission of documentation into project files.
9. Preparation of regulatory dossier, regulatory submission and follow-up.
10. Preparation of EC dossier, EC submissions and follow-up.
11. Co-ordinating arrangements for the investigators meeting, acting as a host for this meeting.
12. Development of meeting materials along with required presentations for investigators meeting.
13. Site initiation visit planning, preparation, conduct, report and follow-up of pending issues.
14. Co-ordinating the IP request between sites and pharmacist/ vendor/ sponsor. 

Desired Candidate Profile :

UG : B.Pharma - Pharmacy, PG : M.Pharma - Pharmacy, Doctorate : Any Doctorate - Any Specialization, Doctorate Not Required

Worked in Ophthalmology or Oncology studies Clinical Studies I-IV

1. Ability to interact professionally with clients/vendors.
2. Excellent interpersonal, verbal and written communication skills and ability to work in a team.
3. Effective time management skills and prioritize tasks to manage study timelines.
4. Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word etc, sound presentation skills.
5. A minimum of 65% on average.

Recruiter Name : M. Chaarumathi

Email Address : careers-asia@ecronacunova.com 

Website : http://ecronacunova.com/

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Regards,

Deepak Kumar Bandari,

Pharm.D Intern,

Vaagdevi College of Pharmacy - India

Elsevier Student Ambassador - South Asia

Drug Safety Associate - Clinical Development : Dr.Reddy's

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Drug Safety Associate, Clinical Development - Dr. Reddy's

Role : Drug Safety Associate, Clinical Development

Number of Openings : 01

Experience required : 1-3 years in Pharmacovigilance operation

Location : Hyderabad

Dr. Reddy's Laboratories Ltd. is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products - Dr. Reddy's offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Major therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management and anti-infective. Major markets include India, USA, Russia-CIS and Europe apart from other select geographies within Emerging Markets. 

For more information, log on to: www.drreddys.com

Job Profile: 

1. Assimilate information on adverse events, perform initial checks, update safety data tracking tool, do case validation, preliminary assessment of case reportability and create case report file.

2. Ensure complete and consistent data entry of adverse event reports from source documents with acceptable timeline and quality.

3. Manage handling of non-expeditable AE reports, legacy AE reports including review for completeness and accuracy.

4. Use medical dictionaries and business guidance to check correct coding of medical history, drugs and adverse event terms.

5. Identify clinically relevant information missing from case report and facilitate its collection (from medical team) to generate appropriate follow-up request as needed.

6. Alert manager about important safety concerns based on preliminary case reports.

7. Work with drug safety team to ensure high compliance for end to end ICSR management.

8. Work with drug safety team in various safety data related administrative and procedural activities as required or requested.

Educational Qualification :  Masters Degree in life sciences or related fields; or equivalent.

Professional requirement :

1. Good understanding and experience of adverse event cases processing (ISCRs) from various sources such as Spontaneous, Post marketing surveillance Studies, Published Medical Literature, Health Authority/ Legal notification & Clinical Trials etc.
2. This includes primarily, case processing, coding of events, medical history and drugs, narrative writing etc.
3. Familiarity and general understanding of medical terminology, experience in working with medical dictionaries (MedDRA & WHO DDE).
4. Good understanding of pharmacovigilance, Global and local regulatory reporting requirements, etc.
5. Experience with working on Global standard safety data bases such as ARISg and/or Argus safety.
6. Basic understanding of clinical trials procedure.
7. Good ability to ability to write good English or communicate.
8. High commitment for compliance.
9. Sense of urgency and commitment for timely completion of activities.

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Regards,

Deepak Kumar Bandari,

Pharm.D Intern,

Vaagdevi College of Pharmacy - India

Elsevier Student Ambassador - South Asia

Manager - Medical Monitoring : Dr. Reddy's

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If you see an opportunity you would like to explore further, do write in to us with your CV on careers@drreddys.com.

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Happy Blogging...!!!

Regards,

Deepak Kumar Bandari,

Pharm.D Intern,

Vaagdevi College of Pharmacy - India

Elsevier Student Ambassador - South Asia

Walk in for Clinical and Project Management - Quintiles

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Walk in Event for Clinical and Project Management - Aug 8 2015 in Quintiles - Bengaluru 

Role: Clinical Research Associate / Scientist

Number of Openings : 50

Experience required : 1-6 years

Location: Quintiles, Etamin Block, Wing A, Prestige Tech Park II, Outer Ring Road, Sarjapur, Bangalore - 560103

Date : 8 - August 2015, 08:00 am

Documents to carry : CV, last 3 months pay slip, id proof

Interview process : Assessment process - CV screening- Aptitude tests- HR Interview- Technical interview- Final interview.

Salary : 2,50,000 - 7,50,000 P.A

Company profile: Quintiles is the world's largest provider of biopharmaceutical development and commercial outsourcing services. We bring a fully integrated approach to build biopharma and life sciences solutions - from pipeline through portfolio to population health. A career with Quintiles connects you to great opportunity to achieve professional success and impact healthcare around the world.

More details: 

1. Clinical Research Professionals Candidates with 1-8 years of experience in clinical research field.

2. Records Management Professionals Candidates with 2-6 years of working in the field of clinical research or in a parallel lead role. Strong ability to identify clinical research documents. Knowledge of systems, databases and software programs. 

3. Project Management professionals Candidates with 5+ years of experience in project management preferably in clinical / healthcare domain. 

Desired Candidate Profile :

Education:

UG : Any Graduate - Any Specialization, B.Pharma - Pharmacy, BDS : Dentistry

PG : Any Postgraduate - Any Specialization, Post Graduation Not Required

Doctorate : Any Doctorate - Any Specialization, Doctorate Not Required

Contact number : 91-80-41384900

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Regards,

Deepak Kumar Bandari,

Pharm.D Intern,

Vaagdevi College of Pharmacy - India

Elsevier Student Ambassador - South Asia

Message to Indian Pharmacists: Opportunities in the Global Market

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I'm very much thankful to His excellency Lt. Colonel PRASAD R TIRUNAGARU M. Pharm., MSC, R.PH for sharing this valuable information with us.

Lt. Colonel Prasad received his B.Pharm and M.Pharm degrees from Andhra University and Medical Service Core training as a combat pharmacist at the Academy of Health Sciences of US Army Medical department centre, Texas, USA. He was the first South Indian to be commissioned as an officer in the US Army. He was the first foreigner to pass the prestigious California State Board Exams in the world.

He has thirty five years of experience as a registered pharmacist in USA, as Assistant Chief and Chief of Pharmacy in various army medical centres. Specialties include clinical research in developing human genetic insulin, nutritional studies, in-patient and outpatient pharmacies, oncology, chemotherapy and nuclear pharmacies. Developed hospital formulary, clinical training modules for healthcare professionals.

Message to Indian Pharmacists: 

US Job Market: There is always great demand for registered pharmacists in USA, the pharmacists are highly respected, most trusted and well paid professionals. The average salary is $120,000 to $200,000 per year. 

Retail and Community Pharmacist: It provides majority of the pharmacist jobs in USA. The major function of the pharmacists is filling and dispensing medications by reviewing and interpreting physician orders, detecting therapeutic incompatibilities. They counsel the patients regarding drug usage, side effects and precautions, they also administer vaccines and drug information. They help physicians and healthcare professionals regarding proper usage, selection of medications and therapeutic guidelines. 

Hospital Pharmacist: Pharmacists play a very important role as a healthcare team member in the hospital providing high quality comprehensive pharmaceutical care. Specialties include outpatient pharmacy, inpatient pharmacy, oncology/IV Admixture. They dispense all required medication to the wards for patient administration. They provide clinical drug data, therapeutic information to all medical team members, monitor drug reactions and patient profiles. They help patients with drug counselling to optimize therapy. 

Clinical Pharmacist: Clinical pharmacists play a vital role in the applied therapeutics; they require 1-2 years of specialized programmes and training in various specialties, i.e., ambulatory care, internal medicine, pediatrics, psychiatry, geriatrics. They are well paid. They are part of every medical and therapeutic team in the hospital. Recently, State Provider Statues Bill became law in many US states. The Legislation provides that “A pharmacist may perform any patient care service delegated to the pharmacist by a physician”.

Industrial Pharmacist:This is a very promising field, specialties include drug discovery, drug development, manufacturing, clinical trials and marketing. Now, there is an exciting new world bioinformatics, genome therapy, stem cell research and promising nano-technology. 

Regulatory Authorities: US Food and Drug Administration and State Boards of Pharmacies have special and important jobs. FDA has several mission-critical medical and science positions at biological evaluations, drug evaluation and research, food safety, applied nutrition, toxicological research and drug inspectors, drug regulatory authorities at various state boards.

Immigration to USA: The important step is getting an immigrant visa to enter into USA. The choices are go for higher education or PhD in various universities. The other one is getting a dependent visa.

State Board Exams: All foreign graduates must obtain certification by the Foreign Pharmacy Graduate Equivalency Committee (FPGEC) before they can get an intern pharmacist licence. They must pass Foreign Pharmacy Graduate Equivalency Exam. In order to practice as a registered pharmacist, you have to pass the North American Pharmacists Licensure Examination (NAPLEX). Rules vary from state to state, please check individual state websites.

Tips for Passing Board Exams

Pharmacy Law: It is a very important part of the State Board Exam. Laws are very strict and precise; each state has its own state board of pharmacy laws. 

Pharmacy Mathematics: Our students can easily get 100% , mostly drug dosing conversions, drug percentage calculations and drug formulations etc. 

Drug Identifications: They must be able to identify important medications by color, shape, markings on tablets. PDR has all the information. 

Trade and Generic Names: They need to learn generic and trade names for the top 200 drugs and more. 

Drug Interactions: It is very important to know pharmacological actions of various important drugs, their medicinal chemistry, actions on target organs, drug metabolism, excretion and side effects. 

Drug and Food Interactions: They have to know food and drug interactions of all critical drugs. 

Clinical Pharmacy: It is a very critical part of patient case studies, patient profiles and interpretation of clinical laboratory tests and adverse drug reactions.

Important websites: www.educationusa.state.gov , www.nabp.net , www.drugs.com

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Happy Blogging...!!!

Regards,

Deepak Kumar Bandari,

Pharm.D Intern,

Vaagdevi College of Pharmacy - India

Elsevier Student Ambassador - South Asia