Career opportunities for Bio-science, Pharmacy & Medical Graduates and 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

Openings @ Quintiles,for Medical Data Reviewer-only Medical Graduates

Identify any anomalies in patient reported data that require further investigation with the clinical site to determine overall accuracy and medical consistency
Review investigation product dosing records to determine adherence to protocol and identify possible inaccurate / missed dosages
Review all reported Adverse Events (AEs) to ensure all supporting information is expected and/or implausible data is verified. Review all reported Concomitant Medications to ensure no medication is disallowed per protocol, supports an existing reported medical condition or is prescribed for a reported AE
Review all inclusion and exclusion criteria to ensure each patient meets minimum level of acceptance into the clinicaltrial
Ensure proper end-of-study (EOS) information is correctly documented to determine primary reason for the patient ending participation in the clinicaltrial
Review all laboratory results to ensure completeness of information supplied, adherence to protocol schedule of events and determine if reported laboratory values represent a potential safety condition not reported in the AE information for the patient
Review all patient reported medical history information to verify completeness of reported information, adherence to protocol expectations and its impact on other patient reported/observed information (e.g., laboratory results, AEs, etc.)
Review additional information, as necessary, to determine overall readiness of the patient information for next level review
Review all supplied Line Listings, patient profiles to determine data accuracy across patients within a specified group of data points
Review status information and data flow reports and take appropriate actions
Serve as POC/ Back-up POC
Interact with other Medical review staff to verify/clarify information and/or triage new data issues or prior identified action items
Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.

Should have experience working with English/Allopathy drugs

 

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Senior Medical Writer: Clinical Evaluation Report (cers) Cactus Communications

CACTUS Medical offers medical writing services to multinational biopharmaceutical and devices companies, clinicalresearch organizations, and researchers worldwide. We work with clinicians and researchers to help them communicate their science to the world. We are currently looking to add to our team, experienced medical writers who have exposure to regulatory writing as well as hands-on experience of writing on medical devices or CER writing experience, and who aspire to be part of a world-class delivery team, and work in an exciting, fast-paced global environment.

As a CER writer in the CACTUS Medical team, you will:

• Ensure timely production of high quality CERs for devices across therapeutic areas
• Screen and summarize literature for relevant clinical data
• Review literature to elucidate the clinical problem and current treatment techniques
• Study and report device characteristics and instructions for use
• Evaluate data for similar competitor devices
• Summarize post-marketing surveillance and risk management data for the target device
• Work with senior writers to prepare documents that meet client expectations in terms of content, format, and presentation

Location: Andheri (West)

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Drug Safety Associate - Voice Process - Night Shift Synowledge PV Services India Pvt Ltd

JOB TITLE: Drug Safety Associate

LOCATION: Mysore, India

YEARS OF EXPERIENCE: 0 to 1 years

EDUCATION: Health care professional (BPharm / B Sc nursing/ BDS/ MPharma/ Pharm D) OR PostGrads in Biotechnology, Microbiology, Biochemistry,Clinical Research, Bio-Physics, Molecular Biology, Medicinal Chemistry,Nuclear Sciences, Bioinformatics

ESSENTIAL DUTIES AND RESPONSIBILITIES:
As Case Intake Member:
Responsible for case intake, duplicate check , and registration
Maintain log of source documents and other communications

As Case Processor:
Responsible for data entry of individual case safety reports into the safety database.
Review and evaluate AE case information to determine required action based on and following internal policies and procedures
Process all incoming cases in order to meet timelines
Full data entry including medical coding and safety narrative

As Medical Coder
Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD)

As Narrative Writer
Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.

As Literature Review Specialist
Ensure effective and accurate collection, recording, review and reporting of literature searches conducted.
Review of literature articles to identify case safety reports.
Responsible for operational Pharmacovigilance activities for assigned developmental and/or marketed products.
Assist in signal generation and safety analysis activities.
Ensure quality of literature searches and reporting.
Review of local/global literature reports to determine regional reportability.
Create/maintain study summary documents.
Assist with narrative writing for periodic/ad hoc submissions.
Assist with ad hoc or routine safety monitoring activities.
OTHER RESPONSIBILITIES:
Following up with sites regarding outstanding queries.
Follow up on reconciliation of discrepancies.
Follow departmental AE workflow procedures
Closure and deletion of cases
Perform any other drug safety related activities as assigned
Perform literature review activities when trained and assigned.

SPECIALIZED KNOWLEDGE AND SKILLS:
Basic competence with medical and therapeutic terminology.
Ability to work independently but guided by documented procedures, with appropriate support.
Able to work effectively as part of a team.
Understanding of patient safety regulatory obligations.
Should be familiar regulatory &pharmacovigilance guidelines.
Should be familiar with pharmacovigilance terminology.
Excellent attention to detail.
Ability to deliver within established timelines.
Fluency in English and excellent comprehension.
Computer literate.

COMMUNICATION SKILLS:
Requires a proactive approach and excellent written/oral communication and interpersonal skills. Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective cross- department communication. Ability to document and communicate problem/resolution and information/action plans.

DESIRED TECHNICAL SKILLS:
Person should be familiar with MS Office Tools.
Safety database knowledge.

OTHER SKILLS:
The ability to contribute to a team environment with a high degree of professionalism and skill. Demonstrate flexibility within a dynamic, fast-paced, cross-functional team. Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment. Ability to perform under stringent timelines.

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Opening for Quality - CDM Cognizant Technology Solutions India Ltd

Minimum of 1 years relevant experience in Clinical data management, Pharmacovigilance or equivalent clinical domain or hands on relevant QC experience. Prior experience in performing QC activities preferred.

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