Wednesday, 7 October 2015

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.

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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