Clinical Research Associate -2 - 6 Years-Mumbai

 

Job Description

• Should have minimum 2 years of core on-site monitoring experience.
• Facilitate and coordinate with investigator and site for EC submission and approval.
• Conduct site feasibility and qualification visits.
• Prepare for kick-off meetings to train vendor representatives involved if out-sourced activity for
• monitoring.
• Coordinate with investigator and sites for IM and assist PM in planning for IM
• Conduct SIVs, write SIV reports, and dispatch to sites
• Monitor sites, write monitoring visit reports and send timely monitoring follow-up letters to
• sites.
• Report SUSARs to regulatory authorities and all SAEs to sites, ECs, and investigators.
• Coordinate with data management team and investigator/site team for timely DCF resolution.
• Ensure CSR submission by investigator to EC, to regulatory authority (as applicable)
• Conduct site close-outs and write close-out reports and dispatch to sites.
• Arrange trial document archival at sites, in-house, and/or by third party as applicable.
• Revise SOPs and write new SOPs as applicable.
• Maintain and keep updated training file and CV for department records
• Assist PM in trial-related activities.

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NH Case Processing Associate-Accenture 2 - 6 yrs Chennai

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.
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Antibiotic Resistance (November 2015)

Opening with Grail Research(a Division of Integreon)- Pharma Research INTEGREON

About Grail Research
Grail Research (www.grailresearch.com) specializes in conducting strategic research including market, industry, and benchmark analyses for leading companies and investors across the globe. As part of Integreon (www.integreon.com), a leading global provider of KPO services, Grail Research offers an intellectually challenging and learning driven work environment designed around developing and delivering cutting edge research products.
Designation: Analyst Primary Responsibilities
Work with project teams and design analysis plan and most effective search strategies. Gather required information and filter relevant themes using a broad set of tools (e.g., subscription databases, the Internet, print media, company representatives, external research organizations, telephonic interviews with industry experts, etc). Utilize both secondary and primary (interview, survey) research sources and techniques
Organize, analyze, synthesize and/or summarize data and information using appropriate analytical tools. Conduct quantitative (e.g., statistical analysis, financial data analysis, etc.) and qualitative analysis (in-depth interviews, etc) as necessary
Communicate research results through the creation of structured end-products (memos, spreadsheets, reports, presentations, etc.)
Required Skills
0.6 to 3 years of relevant research experience
Strong analytical aptitude problem solving, quantitative
Strong verbal and oral communication skills
Team player and excellent interpersonal skills
Logical and creative thinker with enthusiasm and a desire to get involved at Grail Research

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Regulatory Support for Eu/us - OTC Or Cosmetics- iMEDGlobal

Responsibility

Specific day to day responsibility of the SMP support for EMEA position includes, but not limited to:
Ensure that standards and timelines are met
Use of regulatory data base (Register) and IT tools (GSS, Optiva, Starfish)
Create and update working practices for processes used between Outsource partner & EMEA Regulatory Affairs, using a lessons learned approach
Plan and track resource levels required and used for regulatory support requested.

Experience/Qualifications

Life Science or Chemistry or Pharmacist Degree or equivalent qualification.
Experience in European Regulatory Affairs for health products. Experience with Personal Care products would be desirable.
Demonstrate excellent communication skills both oral and written.
Analytical thought

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Quality Assurance - Pharmacovigilance-Crest

6,00,000 - 8,50,000 P.A
Job Description

• Communicate with Operations and clients to ensure compliance with Project Sops and Regulatory guidelines
• Prepare for regulatory as well as client audit
• Act as Compliance / safety lead for projects
• Prepare & conduct Internal Audits
• Implement and maintain effective Quality Assurance systems to ensure that local operations are in full compliance with Compliance standards and policies, GVP, GDP and regulatory requirements by performing the following
• Establish and manage Annual Quality Plans approved by relevant stake holders
• Corrective and Preventive Actions (CAPA) (including RCA and deviations)- Develop local processes based on global ones to conduct root cause analysis to investigate deviations and develop CAPAs. Demonstrate that the CAPA plans required are effectively implemented, monitored and closed out.
• Auditing Ensure a Local process is in place to support Audit activities as necessary, including Health Authorities Inspections. 
• Assist with self-inspections and ensuing corrective/preventive actions
• Manage quality alerts and regulatory intelligence.
• Manage Local Training activities as necessary. 
• Ensure the maintenance of the QMS through the appropriate impact assessment and QMS Management review processes.

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Pharma Data Entry Associate-Accenture

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.

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Officer - Pharmacovigilance (medical Writer) 1 - 5 YearsMumbai

Job Description

1. Preparation of Aggregate Safety Reports (ASR) for regulatory submissions
2. Quality review of Aggregate Safety Reports 
3. Preparation and maintaenance of ASR tracker

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Clinical Research, Records Management Associate (0 - 3 yrs exp)-

Walkin Interview from 19th November to 20th November from 10 AM
Job Requirements:

1. Downloading, Quality check and Indexing TMF documents

2. Importing individual documents with the help of eTMF3 

    application or preparing batch import script in case eTMF3 

    servers are down

3. Communicating any issues, queries with Trial Document

    Manager and acting on the resolution

4. Maintaining study trackersGood Communication Skills

5. MS Office knowledge

5. Willingness to work in Night Shifts

5. Min 6 months relevant experience (Mandatory) 

Location- Pune (Talawade)

Contact Details

Recruiter Name:Vishal Salve

Contact Company:Syntel Ltd

Telephone:020-30615000

Reference Id:Clinical Research

Playing it Safe With Eggs -What You Need to Know

Fresh eggs must be handled carefully to avoid the possibility of foodborne illness, often called "food poisoning." Even eggs with clean, uncracked shells may occasionally contain bacteria called Salmonella that can cause an intestinal infection.

The U.S. Food and Drug Administration (FDA) estimates that 142,000 illnesses each year are caused by consuming eggs contaminated withSalmonella. FDA has put regulations in place to help prevent contamination of eggs on the farm and during shipping and storage. But consumers play a key role in preventing illness associated with eggs. In fact, the most effective way to prevent egg-related illness is by knowing how to buy, store, handle and cook eggs — or foods that contain them — safely. Follow these safe handling tips to help protect yourself and your family. Read More

Clinical Trials and Human Subject Protection

Adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) is universally recognized as a critical requirement to the conduct of research involving human subjects.  Many countries have adopted GCP principles as laws and/or regulations.  The Food and Drug Administration’s (FDA’s) regulations for the conduct of clinical trials, which have been in effect since the 1970s, address both GCP and HSP.  These FDA regulations and guidance documents are accessible from this site.  International GCP guidance documents on which FDA has collaborated and that have been adopted as official FDA guidance are also be found here.  Finally, this site includes links to other sites relevant to the conduct of clinical trials, both nationally and internationally. Read More  

Clinical Research Associate 1 Quintiles-Bengaluru/Bangalore , Mumbai , Ahmedabad , Delhi/NCR(National Capital Region) , Chennai

Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
Build awareness of features and opportunities of study to site.
Collaborate and liaise with study team members for project execution support as appropriate.

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Helping to Speed Cures and Treatments to Patients

The U.S. Food and Drug Administration is committed to helping deliver innovative, safe, and effective treatments and cures to the patients who need them as quickly as possible. To achieve this goal, we have implemented a variety of expedited review programs and are working to help shorten the development time before a product is even submitted for FDA review.

Accomplishments: Drugs

As a result of these efforts, in 2014 alone, FDA approved 51 new molecular entities and biological products (41 by our Center for Drug Evaluation and Research and 10 by our Center for Biological Evaluation and Research). These approvals included major therapeutic advances in the treatment of cancer, hepatitis C and type-2 diabetes. They also included vaccines for meningococcus type B, and more new orphan drugs for rare diseases than any previous year in our history.

Accomplishments: Devices

We’ve also made strides with medical devices. As a result of activities coordinated by CDRH Innovation, and programmatic improvements and innovative use of our existing approval and clearance pathways, many devices investigated in the United States now reach the market a full year sooner than they did at the beginning of this decade. Read More

FDA approves Darzalex for patients with previously treated multiple myeloma

Today the U.S. Food and Drug Administration granted accelerated approval for Darzalex (daratumumab) to treat patients with multiple myeloma who have received at least three prior treatments. Darzalex is the first monoclonal antibody approved for treating multiple myeloma.

Multiple myeloma is a form of blood cancer that occurs in infection-fighting plasma cells (a type of white blood cell) found in the bone marrow. These cancerous cells multiply, produce an abnormal protein and push out other healthy blood cells from the bone marrow. The disease may result in a weakened immune system and cause other bone or kidney problems. The National Cancer Institute estimates there will be 26,850 new cases of multiple myeloma and 11,240 related deaths in the United States this year.

“Targeting proteins that are found on the surface of cancer cells has led to the development of important oncology treatments,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. “Darzalex provides another treatment option for patients with multiple myeloma who have become resistant to other therapies.”

Darzalex injection, given as an infusion, is a monoclonal antibody that works by helping certain cells in the immune system attack cancer cells.

Read More

Officer - Medical Services Glenmark Pharmaceuticals Ltd

Summary: To collect, monitor, assess and evaluate information received through Perception, Opinion & Expertise of Medical Professional studies in order to research a target market and get a feedback of our Products.
This would help to ensure that enough safety information is available on the products that we market across the globe.

PERCEPTION, OPINION & EXPERTISE OF MEDICAL PROFESSIONAL (POEM) STUDIES:

List of doctors with contact details / consent letters are received from marketing team.
Keeping track of booklet received.
Maintenance of study documents and replication of data into excel sheet.
Maintaining and updating internal database for POEM studies
Updating the marketing team on regular basis for receipt of POEM study documents
Analysis of the data after data entry is done.
Preparation of Final report
IN CLINIC DATA COLLECTION (ICDC) STUDIES:
List of doctors with contact details/ consent letters are received from marketing team
Handing over ICDC booklets over to respective doctors
Undertaking Follow ups at regular intervals to collect necessary information with respect to patient
recruitment status, adverse events and to check the progress of the study.
Collection and maintenance of Study documents after completion of the study
On receiving the completed ICDC booklets, the data is transcribed into excel sheet to prepare a database for further analysis.
Booklets with adverse events are reported to PV department
Keeping track of booklet received.
Compliance of local ICDC SOPs.
PHARMACOVIGILANCE:
Timely reporting of any adverse events to Pharmacovigilance System
Receive and track all spontaneous and clinical study cases
Forward reports to Central Processing or to Contractual partner as appropriate.
Follow up of certain cases
Source records retention
Coordinating with MIDAS (Medical Information Service) Manager for any safety information
Training of field force and maintain records of training.
Adhering to LPvRP working guidelines
Perform QC check of reported cases to contractual parties fortnightly.
Coordinating with marketing/CQA in case of Product complaints or adverse events
Coordinating with Global PV team to provide them with required information/documents

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Opening for Medical Writing/ Scientific Writing at Indegene, Bangalore

Kindly find the job description:
1.Responsible for authoring regulatory/ safety documents such as Protocol, CSR, IB, Clinical Overviews & Summaries, Subject Narratives, Aggregate Reports, RMPs and others
2.Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations
3.Ensure that clinical documents adhere to current global standards, FDA, ICH and GCP guidelines and are in accordance with electronic publishing standards. Update SOPs and other job aids for completeness as needed



Required Skills:
1. Minimum 4 years of experience in pharmaceutical companies in any of the following functionsregulatory-medical writing/developing/publishing medical content
2. Understanding of any specialty area of medicine (preferred) or an overall understanding of the medical field.
3. Strong flair and passion for writing.
4. Strong written and verbal communication/presentation skills.
5. Passion for networking.
6. Being up-to-date with the latest technical/scientific developments and relating them to various projects.

M. Pharm/BDS/ MBBS/ Ph.D with 3 to 4 years of experience in Regulatory Writing

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Current status of clinical research in India

Clinical research has grown exponentially over the past decade in India because of cost advantage, treatment natïve patient, qualified doctors conversant in English etc. India was the second most preferred country to conduct clinical trials outside the US in 2009. However, recent years have witnessed a decline in number of trials in India (529 in 2010; 253 in 2012). The number of drugs entering the Indian markets had been gradually reducing even before the current slump in clinical research activity (270 in 2008;140 in 2011; 44 in 2012 and 25 in 2013). This necessitates a relook on the strategy so as to optimise clinical research in Indian context. The problems and possibilities around the clinical research arena can be broadly grouped as capacity building issues and ethico – regulatory ones.

In India, Drug Controller General (India) (DCGI) is the competent authority for approving clinical trials as well as manufacturing and marketing drugs. DCGI grants approval after appropriate clinical trials are conducted in India with adequate number of trial subjects. To begin with, there are scant training resources to train adequate number of researchers so as to carry out research activities as per the international standards. There is a need to build dynamic training modules and platforms which confirm to international regulations and best practices while addressing peculiar national needs. The training infrastructure needs to be flexible enough to accommodate ever changing regulatory landscape. We have a thriving knowledge base of traditional medicine systems which cater to a large segment of the population are regulated by a separate Department of AYUSH. There is a requirement of involving AYUSH practitioners in collaborative research and reorient the research regulations so as to effectively monitor research in AYUSH. Recent draft notification regarding regulations for ‘Phytopharmaceuticals’ is a step in this direction.

Though India has a robust regulatory apparatus, it is perceived that Indian patients being poor and less informed are vulnerable. While isolated instances of unethical clinical trials cannot be ignored, a more informed debate and perception management is the need of the hour. The confidence building amongst all stake holders has now assumed paramount importance. Read More

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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