The Working Environment-Pharmacovigilance

Pharmacovigilance working environment is highly dynamic in nature. Here you will find to apply your concepts to identify, doing analysis and concluding different types adverse drug reaction as well as adverse drug event. To execute such kind of activities, one has to understand concerning source documents belong to research subjects and protocols.

Pharmacovigilance department with PV professional works on case basis, where they needs to do the case assessment to find the intensity, seriousness, expectedness and causality. Causality assessment is another set of activity is usually done.

PV professionals are usually works within a specific location in office. It is not the kind of job profile where you have to move from one place to another place frequently except pharmacovigilance operations. It is a sustainable and full of growth based career with respect to nature of work as well as learning new aspect of work along with knowledge.

Pharmacovigilance: A lucrative career option in INDIA for Bio-Science, Pharma, Medical & Para Medical Graduates & Post Graduates

India has become a major hub for clinical trials. Despite this, several problems related to availability of drugs, distribution, accessibility and consumption still remain at large. 

Pharmacovigilance is the discipline which takes care of such aspects and is concerned with identifying, validating, quantifying and evaluating adverse reactions associated with the use of drugs thereby improving the safety of medicines in use. 

Bio-Science, Pharma, Medical & Para Medical Graduates & Post Graduates can enter into these sector a career option. All major CRO, Bio-pharma organization, Medical Device companies, KPO, BPO and IT Life Science companies is on the move of hiring knowledgable anad certified pharmacovigilance candidates.

Now here, any aspirant who wants to join in this industry should focus in two basic issues . The first point is, developing a strong pharmacovigilance knowledge base and the second one is preparing him or herself for interview.

While making a choice of developing knowledge development, as a candidate, you need to do a certificate program in pharmacovigilance. There is no mandetory need of university approved certification or duration of program as a key factory for hiring terms & condition from leading organization, but all the hiring organization typically looks into the quality of knowledge base that a candidate have with them, so that they can use the knowledge to implement into the project management aspects directly.

So, aspirants should focus on individual goal about the learning process and content of the syllabus rather than large amount course fee, brand institutions, good infrastructure and campus etc. The chance of getting jobs after completion of the program is totally depends on the aspirants rather than the institute, institute can help the aspirants by providing best possible knowledge base and maximizing the interviewing opportunity, but the ultimate work is to perform well on the day of interview by the candidate, there is no shortcut.

Current trend is that, while selecting an institute for pharmacovigilance certification much importance are given on the content of the program than anything else. Following are some basic outline of any pharmacovigilance certification program which can help you to get jobs.  It should include like, basic principles of pharmacovigilance and clinical research, regulatory affairs environment FDA, CDSCO, EMA, management of pharmacovigilance data, risk management in pharmacovigilance and pharmacoepidemiology, may more etc. The objective should be to develop candidates who are experts at monitoring the adverse effects of the drugs which have been released in the market. Their goal should be to establish safety of the drug and oversee the well-being of the consumers.

Pharmacovigilance is still in its infancy in India, therefore higher standards of pharmacovigilance are warranted to be at par with the rest of the world in terms of not only compliance to regulations but also to implement quality systems in all pharmaceutical companies especially the generic companies which manufacture bulk drugs that are marketed in India and the Western countries. 

There is no shortage of job opportunities in this field as good pharmacovigilance practice makes for good business sense. Students of this field can get jobs in all leading CRO, Bio-Pharma organization, Medical Device companies, KPO, BPO and IT Life Science companies with attractive salaries with robust increments, world class learning and global exposure.

 

Do a pharmacovigilance certification program and get 100% placement support- click here

Redesigning a chemical library to bolster high-quality hit series identification

Well-designed chemical libraries are a critical tool in the race for drug-discovery in an intensely competitive pharmaceutical marketplace. Success in early stages of the drug-discovery process depends on access to quality sample libraries that balance the requirements for chemical diversity and redundancy. Coupled with accurate, rapid and cost-effective HTS technologies and instrumentation, the AMRI Synthetic Compound Collection (ASCC) will improve the chances of identifying high quality hit series through HTS.
As the costs of drug development rise, pharmaceutical companies continue to require high-quality data and cost-effective methods starting with the earliest stages of drug discovery. High-throughput screening (HTS) remains a powerful tool in early-stage research, which allows project teams to identify hits against a target of interest1 . Yet screening of compound libraries remains an expensive process. In order to provide customers with the best chance to identify valid hits and produce successful hit-to-lead investigations, attractive compound libraries need to incorporate collections of diverse compounds that contain clusters of structurally similar analogs. This design approach needs to be achieved while carefully selecting compounds within various physical and chemical property constraints. Well-designed chemical libraries will have greater potential to meaningfully correlate chemical structure of a hit with interactions at its intended target2 . A high quality library in turn increases confidence in the quality of compounds identified as hits.
Much effort in the past decade has been directed to making the HTS process more efficient3 . These efforts include developments focused on improvement to instrumentation as well as screening processes. Screening techniques have also evolved in order to screen libraries of various sizes from a few hundred fragments to large corporate libraries with millions of samples. Parallel to these efforts, chemoinformatics tools have become powerful aids in designing better libraries and evaluating screening results in the context of chemical property as well as structural content of the samples represented in a library4 . Presented here is the selection of an HTS library of intermediate size. To build this quality library, compounds were selected by filtering out those with structural features related to poor assay outcome such as aggregation, reactivity or lack of target specificity and filtering compounds based on desirable ranges of properties such as logP5 . Additionally, compounds were selected with an eye towards chemical diversity and inclusion of small sets of analogs. The resulting library is also analyzed to show good coverage of shape and biological space. All these features have been implicated in positive outcomes of HTS campaigns: The generation of good chemical starting points for hit-to-lead programs

http://vertassets.blob.core.windows.net/download/c3d28fcf/c3d28fcf-8f65-45c3-aaed-0c3090c5f047/welldesignedchemical_whitepaper.pdf

Clinical Research Associate-Cipla-Mumbai

Job Description

1. Responsible for developing strategy for clinical research.
2. Conduct KOL visits to collect scientific inputs during protocol development and planning.
3. Reviewing of protocols and other study related documents.
4. Seeking scientific advice from regulatory agency.
5. Interacting with regulatory agencies on queries.
6. Contributing into report of studies
7. Interacting with team to discuss the further development of product on the basis of results of trial.
8. Medical monitoring of clinical trial
9. Ensuring that clinical trails are conducted according to the protocol, GCP and applicable regulatory requirements

Contact Details

• Recruiter Name:Kamran Ahmad
• Email :kamran.ahmad@cipla.com

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Associate Analyst - Pharmacovigilance (data Migration)-Tech Mahindra

 
INR 2,00,000 - 3,00,000 P.A

Job Description:

 Review of source documents in the individual case safety reports for assigned cases in the project Case book-in
Completion of the heads down data entry from source docs to safety data base
Evaluates consistency, completeness, accuracy of safety database, tracking database and source document
Capturing the correct data in the tracking tool, to assist generation of project related metrics
Document case related observations in the tracking tool and communicate the observations to other associate analysts
Be responsible in meeting timelines, and quality standards.
Be responsible for ensuring 100% training compliance to the client assigned training curriculum
Ensure process steps adherence for the assigned project
Ensure adherence to QC/QA plans as applicable
Mentoring new-hires as designated by the senior manager
Any other responsibility delegated by the reporting manager
The candidates should have a graduate/ Postgraduate Degree in stream with 1-3 year of experience in data entry.
The candidate should have demonstrable proficiency in Microsoft office applications such as Microsoft word, excel and outlook
Ability to work with the team and in  pressure situations
Good English comprehension skills and writing skills .

Walk-in between 10Am to 2PM from 7th to 10th October
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For VOLUNTARY reporting of Adverse Drug Reactions by Healthcare Professionals

SUSPECTED ADVERSE DRUG REACTION REPORTING FORM

Download link - http://ipc.nic.in/showfile.asp?lid=416&EncHid=

Serious Event or Serious Suspected Adverse Reaction-Pharmacovigilance Practice

An adverse event or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes

• Death
• A life-threatening adverse event
• Inpatient hospitalization, or prolonged of existing hospitalization
• A persistent disability to conduct normal functions
• A congenital anomaly/birth defect

Important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious, when based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

A Life Threatening Adverse Drug Experience
Any event that occurred due to the use of drug, if it places the patient or the subject at immediate risk of death or if the product or drug is continued it may result in death is described as a life threatening adverse event.
Some of the examples are:

• Hemorrhaging and internal bleeding with rapid drop in blood pressure,
• Loss of consciousness from increase in pressure on the brain etc.

Hospitalization
Any event that occurred due to which the patient/subject is admitted to the hospital for longer than 24 hours or if the stay in the hospital is prolonged due to the adverse event.
Disability
Any event that occurred due to which the patient/subject is unable to conduct normal life functions
Examples are

• Loss of speech,
• Fatigue( if the subject cannot get out of bed at all),
• Loss of memory,
• Paralysis etc

Congenital Anomaly
Exposure to a medical product before conception or during pregnancy results in an adverse outcome in the child is described as congenital anomaly. Thalidomide is the best example of a drug causing congenital anomalies with babies born with deformed arms and legs.

Author- Sirisha Boidapu, Pharmacist, PV Professional

FDA IND Review Team-Different background people working together

The review team consists of a group of specialists in different scientific fields. Each member has different responsibilities.

-Project Manager: Coordinates the team’s activities throughout the review process, and is the primary contact for the sponsor.
-Medical Officer: Reviews all clinical study information and data before, during, and after the trial is complete.
-Statistician: Interprets clinical trial designs and data, and works closely with the medical officer to evaluate protocols and safety and efficacy data. 
-Pharmacologist: Reviews preclinical studies.
-Pharmakineticist: Focuses on the drug’s absorption, distribution, metabolism, and excretion processes.Interprets blood-level data at different time intervals from clinical trials, as a way to assess drug dosages and administration schedules.
-Chemist: Evaluates a drug’s chemical compounds. Analyzes how a drug was made and its stability, quality control, continuity, the presence of impurities, etc.
-Microbiologist: Reviews the data submitted, if the product is an antimicrobial product, to assess response across different classes of microbes.

S. Pandarinath, Pharmacist, Certified Pharmacovigilance Professional.

Designing Clinical Trials Researchers design clinical trials

Researchers design clinical trials to answer specific research questions related to a medical product. These trials follow a specific study plan, called a protocol, that is developed by the researcher or manufacturer. Before a clinical trial begins, researchers review prior information about the drug to develop research questions and objectives.

Then, they decide:-

-Who qualifies to participate (selection criteria)
-How many people will be part of the study
-How long the study will last
-Whether there will be a control group and other ways to limit research bias
-How the drug will be given to patients and at what dosage
-What assessments will be conducted, when, and what data will be collected
-How the data will be reviewed and analyzed Clinical trials follow a typical series from early, small-scale, Phase 1 studies to late-stage, large scale, Phase 3 studies.

S. Pandarinath, Pharmacist, Certified Pharmacovigilance Professional.

Key concepts to be considered in expedited reports : Pharmacovigilance Practice

The following list of items are to be included in CIOMS form and submitted to regulatory bodies :

1. Patient details (vitals)
2. Suspected medical product( brand name,batch number, dosage form and strength,dosage regimen, route of administration, international non propiatory name, starting date and time , stopping date and name )
3. Details of the adverse drug reaction (starting date, onset of reaction , stopping date and time and duration of reaction )
4. Details of reporter (name, address, telephone number , profession)
5. Details of the sponsor (source of report, country in which event occurred ,name and address of sponsor , sponsor identification number ).

S. Pandarinath, Pharmacist, Certified Pharmacovigilance Professional.

Drug Safety Physician / Medical Reviewer Synowledge PV Services India Pvt Ltd

JOB TITLE: Drug Safety Physician/ Senior Drug Safety Physician

LOCATION: Mysore, India

YEARS OF EXPERIENCE: 0-5 years experience in PV

EDUCATION: MBBS/ MD (Any)

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

As a Medical Reviewer

Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports
Determine regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion
Determine seriousness and relatedness across products as assigned
Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, review narrative.
Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas
Escalate complex case issues on client product(s) to the medical review team of the client as appropriate
Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groups
Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate
Acquire and maintain knowledge of applicable Global Health Authority regulations
Perform any other drug safety related activities as assigned
Participate in internal and external audits and inspections by clients and health authorities


SPECIALIZED KNOWLEDGE AND SKILLS:

Experience with relevant safety databases and related software applications
Proven experience in customer handling and relationship.
Proven ability to perform task management.
Must have good presentation skills and the ability to give presentations.
Knowledge of the Life Sciences Industry and life cycle of drug.
Relevant product and industry knowledge.
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Opening for Medical Writing for M.pharm/pharm.d Freshers,experienced

 Hiring for freshers -M. Pharm/ Pharm. D at Indegene Lifesystems for Scientific Writing/ Medical Writing.


Kindly find the job description.
Develop content for various deliverables meeting quality requirements as per client satisfaction metrics, with active guidance from the manager

Responsible to develop content as per the timelines assigned

Responsible to follow the best practices in the department regarding - processes, communication (internal & external), project management, documentation and technical requirements like - language, grammar, stylization, content search, summarizing, data conflicts and referencing

Participate in assigned training programs and work on assignments as per requirement

Participate in cent calls as per project requirements

Compliance to quality, confidentiality and security:

Adhere and follow quality systems, processes and policies

Comply to training and specifications


Education : M.Pharm/ Pharm. D - Freshers

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Pharmacovigilance Medical & Scientific Writer With Crest - Pune

• Identifying and evaluating individual case safety reports (ICSRs) of adverse drug reactions from the published literature
• creating summary content in a range of formats (narrative summaries, structured database inputs, electronic formats for regulatory filing ) to support the drug safety reporting and information requirements of pharma industry clients
• Required background and experience: you will have working experience in the pharmacovigilance/drug safety field and a background in medicine or pharmacy
• Ideal experience would include:
• 
  
• Scanning the literature or other data sources to identify reportable adverse drug reactions based on accepted industry and regulatory guidelines
• Detailed evaluation of individual case reports e.g. determining seriousness of adverse events, determination of drug causality, subsuming signs and symptoms into clinical diagnoses etc.
• Familiarity with the reporting and regulatory requirements for pharmaceutical companies as mandated by drug safety authorities

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Process Trainer (pharmacovigilance)-Cognizant Mumbai

• Deliver training on the floor - effectiveness measured through Trainer Feedback Score (from Trainees)
• Ensure associates are assigned to process training refreshers based on QA data on associates performance
• Facilitate Process Training Refresher modules effectively measured through Trainer Feedback Score
• Ensure completion of all compliance courses for all associates tagged to the project within timelines
• Willingness to work in rotational shifts
  Only BPharm/MPharm/BDS/BAMS/BHMS candidates need to apply 

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Drug Discovery Technologies Market 2012-18

Drug discovery technologies play a significant role in the field of pharmaceuticals as they heavily contribute to the introduction of drugs to the market. The application of drug discovery technologies have a significant opportunity in  the launch of drugs for severe diseases such as cancer, cardiovascular diseases, Parkinson’s disease, central nervous system disorders and others. However, the slow growth in the introduction of blockbuster drugs could pose a major threat for the growth of this market.

The major technologies in the drug discovery market are proteomics, genomics, QPCR, DNA and protein microarrays, high-throughput screening, mass spectrometry, laboratory information management systems, microfluidics, gel electrophoresis, chromatography, and protein and nucleic acid isolation.

As the global population ages, there is a growing pressure to keep the healthcare costs under control. Senior citizens are more prone to chronic diseases. It is in the nation’s best interests to keep its population healthy. In addition to this the pressure is paired with the government’s and administration’s responsibility to pay for healthcare. This situation will magnify in intensity if nothing is done to improve the status of treatment and prevention of diseases among the aging population. 

Apart from facing these pressures, the pharmaceutical manufacturers also face an impending surge of expiring patents. This will result in reduced profits of pharma companies. The market players in this field have begun to respond to these factors by restructuring their strategies and bringing innovation in their products thus, improving their productivity and efficiency. Despite these measures, pharmaceutical companies face the fact that drug discovery and development consumes a huge amount of time and money. For instance, drug discovery and development from scratch may take around 15 years and costs about USD 500 million until it is introduced in the market.

Big Data Analytics: The Next Evolution In Drug Development

The drug development process is complex and financially risky. A recent study by The Tufts Center for the Study of Drug Development estimates the cost of developing a new drug at $2.6 billion and suggests that costs of drug development are rising with a compound annual growth rate of 8.5 percent. These rising costs are largely driven by increases in out-of-pocket costs, such as larger clinical trial sizes and higher failure rates for drugs required to demonstrate superiority. Even when considering the efficacy of the 10 highest-grossing approved drugs in the United States, the fact is that for every patient a drug does help, between three and 24 patients fail to show improvement after treatment. Clinicians are typically forced to address this variability in patient outcomes with a trial-and-error approach to intervention, increasing healthcare costs and adding a burden to the patient.

Drug Developers, Providers, And Patients Need A Better Option 

High-throughput technologies are ushering in the era of Big Data in drug development, allowing researchers to assay patients in terms of their genome, epigenome, proteome, metabolome, and microbiome. Precision medicine initiatives are being undertaken to tailor disease treatment by taking into account individual variability in molecular and cellular systems. A biomarker- and technology-driven approach to developing targeted therapies and patient selection strategies has the potential to increase success in the drug development process, decrease cost, and ultimately improve patient outcomes with directed intervention. Read More

S. Pandarinath, Pharmacist, Certified Pharmacovigilance Professional.

Serious Event or Serious Suspected Adverse Reaction in Pharmacovigilance Practice

An adverse event or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes :

-Death
-A life-threatening adverse event
-Inpatient hospitalization, or prolonged of existing hospitalization
-A persistent disability to conduct normal functions
-A congenital anomaly/birth defect

Important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious, when based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

Author- Sirisha Boidapu, Pharmacist, PV Professional

Researchers are studying fish which can repair their own hearts.

Hundreds of thousands of people in the UK are living with debilitating heart failure. They can’t regenerate their damaged hearts. But zebrafish can. If part of their heart is damaged they can repair it in a matter of weeks, just like we are able to mend a broken bone.  That’s why our Mending Broken Hearts Appeal is funding researchers to find out what their secret is.

Because zebrafish are transparent early in their life cycle, it’s easy for researchers to see their hearts and blood vessels grow. Their hearts begin to develop after just 12 hours, and they reach adult size – about 3cm long – in about three months, so they can provide quick research results. Read More

Biological similarity of humans and other animals

Although humans and animals (technically “non-human animals”) may look different, at a physiological and anatomical level they are remarkably similar. Animals, from mice to monkeys, have the same organs (heart, lungs, brain etc.) and organ systems (respiratory, cardiovascular, nervous systems etc.) which perform the same functions in pretty much the same way. The similarity means that nearly 90% of the veterinary medicines that are used to treat animals are the same as, or very similar to, those developed to treat human patients. There are minor differences, but these are far outweighed by the similarities. The differences can give important clues about diseases and how they might be treated – for instance, if we knew why the mouse with muscular dystrophy suffers less muscle wasting than human patients, this might lead to a treatment for this debilitating and fatal disorder. Read More

More investment to characterize animal models can boost the ability of preclinical work to predict drug effects in humans

Mice take the blame for one of the most uncomfortable truths in translational research. Even after animal studies suggest that a treatment will be safe and effective, more than 80% of potential therapeutics fail when tested in people. Animal models of disease are frequently condemned as poor predictors of whether an experimental drug can become an effective treatment. Often, though, the real reason is that the preclinical experiments were not rigorously designed. 

The series of clinical trials for a potential therapy can cost hundreds of millions of dollars. The human costs are even greater: patients with progressive terminal illnesses may have just one shot at an unproven but promising treatment. Clinical trials typically require patients to commit to year or more of treatment, during which they are precluded from pursuing other experimental options. Launching a clinical trial without the backing of robust animal data keeps patients out of tests for therapies that may have a better chance of success.Read More