Ankush Arora is seeking a career opportunity with opportunities for professional growth. He has over 3 years of experience in pharmacovigilance and quality assurance. He is skilled in MedDRA coding, case processing, quality reviews, and generating quality reports. Previously he worked as a quality auditor and has experience working with safety databases. He holds a B.Pharmacy degree and is registered with the Delhi Pharmacy Council.
Introduction to ICSR Narrative Writing in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
AN OVERVIEW AND IMPORTANCE OF PHARMACOVIGILANCERamakrishna K
An introduction to pharmacovigilance, basic types like active pharmacovigilance and passive pharmacovigilance, purpose, adverse event reporting, data processing, causality, assessement, signal detection, risk management plans and analysis
Introduction to ICSR Narrative Writing in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
AN OVERVIEW AND IMPORTANCE OF PHARMACOVIGILANCERamakrishna K
An introduction to pharmacovigilance, basic types like active pharmacovigilance and passive pharmacovigilance, purpose, adverse event reporting, data processing, causality, assessement, signal detection, risk management plans and analysis
If you are marketing your product in India you should comply these area of regulation.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
Signal detection is a process used in pharmacovigilance to identify potential safety issues or new safety information associated with a medicinal product. The goal of signal detection is to detect signals, or potential safety concerns, as early as possible in order to allow for timely risk management and safety interventions.
Signal detection typically involves analyzing large amounts of safety data, including adverse event reports, clinical trial data, post-marketing surveillance data, and other sources of safety information. The data is analyzed using statistical methods and algorithms to identify any patterns or trends that may suggest a potential safety concern.
Once a potential safety concern is identified, further investigation is typically required to confirm the signal and assess the magnitude of the risk. This may involve conducting additional studies, analyzing the available data in more detail, or consulting with regulatory agencies and other stakeholders.
Signal detection is an ongoing process that continues throughout the life cycle of a medicinal product. The process is critical for ensuring the ongoing safety and effectiveness of medicinal products, and is an important component of pharmacovigilance activities.
Clinical Evaluation Report for Medical DevicesI 3 Consulting
As per MEDDEV 2.7/1 Rev.4, Clinical Evaluation is a specialized robust method to collect, appraise and analyze clinical data related to a medical device and to interpret if there is satisfactory clinical information (evidence) to establish conformity with pertinent essential requirements for safety and performance when employing the medical device as per the manufacturer's instructions for use.
Feasibility Solutions to Clinical Trial Nightmaresjbarag
Slow patient recruitment and poor retention cause recurrent nightmares and perpetual problems often resulting in missing recruitment milestones. The cost of these delays represents hundreds of thousands of dollars for drug and device developers. By recognizing this issue, early detailed feasibility can provide planning and contingency solutions that are focused on reducing the impact of delayed recruitment. Furthermore understanding what motivates investigators and patients to actively participate in clinical studies and how patient recruitment strategies and materials can support all stakeholders to complete studies on time are critical aspects of clinical study delivery planning.
During this presentation, an experienced Premier Research feasibility and patient recruitment specialist, reviewed feasibility approaches to address protocol evaluation as well as addressed influences on country selection, site distribution and patient recruitment strategies to provide for more effective clinical trial planning and conduct.
For more information, go to http://www.premier-research.com.
TSDP tells about the essential documents that are required for the #conduct of a clinical trial. For #regulatory medical writing training, contact hello@turacoz.in.
Introduction to ICSR Workflow and Management in Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
If you are marketing your product in India you should comply these area of regulation.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
Signal detection is a process used in pharmacovigilance to identify potential safety issues or new safety information associated with a medicinal product. The goal of signal detection is to detect signals, or potential safety concerns, as early as possible in order to allow for timely risk management and safety interventions.
Signal detection typically involves analyzing large amounts of safety data, including adverse event reports, clinical trial data, post-marketing surveillance data, and other sources of safety information. The data is analyzed using statistical methods and algorithms to identify any patterns or trends that may suggest a potential safety concern.
Once a potential safety concern is identified, further investigation is typically required to confirm the signal and assess the magnitude of the risk. This may involve conducting additional studies, analyzing the available data in more detail, or consulting with regulatory agencies and other stakeholders.
Signal detection is an ongoing process that continues throughout the life cycle of a medicinal product. The process is critical for ensuring the ongoing safety and effectiveness of medicinal products, and is an important component of pharmacovigilance activities.
Clinical Evaluation Report for Medical DevicesI 3 Consulting
As per MEDDEV 2.7/1 Rev.4, Clinical Evaluation is a specialized robust method to collect, appraise and analyze clinical data related to a medical device and to interpret if there is satisfactory clinical information (evidence) to establish conformity with pertinent essential requirements for safety and performance when employing the medical device as per the manufacturer's instructions for use.
Feasibility Solutions to Clinical Trial Nightmaresjbarag
Slow patient recruitment and poor retention cause recurrent nightmares and perpetual problems often resulting in missing recruitment milestones. The cost of these delays represents hundreds of thousands of dollars for drug and device developers. By recognizing this issue, early detailed feasibility can provide planning and contingency solutions that are focused on reducing the impact of delayed recruitment. Furthermore understanding what motivates investigators and patients to actively participate in clinical studies and how patient recruitment strategies and materials can support all stakeholders to complete studies on time are critical aspects of clinical study delivery planning.
During this presentation, an experienced Premier Research feasibility and patient recruitment specialist, reviewed feasibility approaches to address protocol evaluation as well as addressed influences on country selection, site distribution and patient recruitment strategies to provide for more effective clinical trial planning and conduct.
For more information, go to http://www.premier-research.com.
TSDP tells about the essential documents that are required for the #conduct of a clinical trial. For #regulatory medical writing training, contact hello@turacoz.in.
Introduction to ICSR Workflow and Management in Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
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Dieta dos Pontos - Aprenda Como Fazer e Comece a Emagrecer Comendo de Tudo
Aprenda a emagrecer com a Dieta dos Pontos do Doutor Alfredo Halpern + versão ProPontos dos Vigilantes do Peso
Motivated and performance driven; clinical and business professional. Determined and passionate about implementing best practices while targeting education and improving staff development efficiently. Expert knowledge of healthcare environment, ability to positively influence behavior for quality patient outcomes. Demonstrates ability to creatively use consulting and listening skills when working with interdisciplinary teams, promoting consensus with communication and transparency of program goals. Organized and presents research and analytic benchmarks proficiently with cross functional team collaboration.
Assignment ObjectivesSummarize the purpose of a performance impro.pdfrohit219406
Assignment Objectives:
Summarize the purpose of a performance improvement plan.
Summarize and organize the steps needed in the creation of a performance improvement plan.
Purpose: It is important to understand the performance improvement plan and how it works. You
will all work in a setting, whether it be a hospital or a physician’s office managed by a hospital,
where you will get audited and have certain standards to meet. It is important to be prepared and
understand this information now.
Assignment Description: When dealing with a performance improvement plan, there are many
things to consider. I would like for you to write a report detailing how a performance
improvement plan is written. Start with what the criteria is and how it is determined. Move on to
the action plans and then end with the formal report.
Parameters: This paper needs to be at least 1,000 words in length. You need to have at least 3
sources. This paper needs to be in APA format.
The paper will be graded by the following rubric:
Essay contains correct subject matter and covers the objectives, 50
Proper format – introduction, body, and conclusion, 15
Length – 1,000 words at least, 5
APA Style and format, 5
Used proper number of resources, 15
Grammar, spelling, and punctuation, 10
Solution
Performance Improvement Plan :
Following structure will be followed for developing performance Improvement Plan .
Mission Statement:
To offer the best in patient care and to endorse community health.
Vision:
To be a leading hospital provider in the located area.
Service superiority:
Expecting and exceeding expectations of all we dish up: our patients and their folks, providers,
staff, students, volunteers and other partners.
Dynamic work surroundings
Fostering an setting where all are valued and respected, and fervor and opportunities for expert
growth are encouraged.
Building on centers of medical and organizational superiority Doing the right thing by centering
on evidence based patient- and family -centered mind, a commitment to security, the importance
of knowledge and our mission, vision and values.
Innovation and teamwork Building/fostering corporation to enhance care, meet society need and
foresee the demands of a active healthcare environment.
Financial and resource stewardship :
Keeping clinic strong through the accountable use of financial and human resource.
PURPOSE
The principle of the Hospital performance Improvement Plan is to provide a structure for a
collaboratively planned, systematic and company -wide approach to improving organizational
routine. It is designed to provide an included and comprehensive program that will scrutinize,
assess and improve the superiority of patient care delivered at this flair.
Promise to performance :
The core of the hospital performance Improvement Program is that it tackle quality in all areas
and at all levels all through the organization.
For Hospital to succeed in the swiftly changing and increasingly spirited healthcare atmosphere
in t.
Assignment ObjectivesSummarize the purpose of a performance impro.pdf
Ankush Pharmacovigilance CV
1. ANKUSH ARORA
Mobile No.: +91 9654731370/9654776770 E-Mail: aroraankush012@gmail.com
Seeking an opportunity for professional growth and increasing responsibility. An organization where
individual and team spirit is recognized and rewarded
ABRIDGMENT
• A career oriented professional with an experience of Approx 3 years in the field of Pharmacovigilance & Quality
associate
• Adept at providing MedDRA coding, Spontaneous case processing, Overview of case processing & guidelines,
documenting processes, procedures and analytical findings.
• A keen learner with constant zest to acquire new skills.
• An effective & efficient communicator with strong analyst
EXPERIENCE
Mar2016- Till present Working in Cognizant Technology Solutions, Mumbai as a “Specialist-TQ”
Job Responsibilities:
• Quality Review of post-marketing/solicited, spontaneous and literature cases adhering to Standard
Operating Procedures
• Generate quality reports and analysis of the same
• Provide inputs to improve accuracy levels and aid in reduction of errors
• Identify training needs and area of improvement for the bottom performers and for the team
• Conduct Quality awareness sessions and initiation or participation in quality related activities
• Query resolving
Previous Positions:
Feb2014- Feb2016 Worked in Wipro, Sarita Vihar as a Quality Auditor
• To perform Individual Case Safety Report (ICSR) quality control (QC)
• To Route processed ICSRs to next workflow.
• Excellent interpersonal, written and verbal communication skills
• Good IT skills with good industry knowledge
• Ability to manage multiple and varied tasks and prioritize workload with attention to detail
• Willingness to work in a matrix environment and to value the importance of teamwork
• Perform medical coding using MedDRA and WHO-Drug dictionaries
July 2012- Feb 2014 Paras hospital
2. Sr Pharmacist
Key Role:
• Issuing Medicine to the department as per stock level.
• Issuing Medicine to the In-Patient Department
• Checking the Supply from the vendors.
Jun 2010- July2012 Max Hospital
Pharmacist
Key Role:
• Follow the patient’s progress to determine the effects of the patient’s medications on his or her health.
• Consult with the patient’s physicians and other health care providers in selecting the medication therapy that
best meets the patient’s needs and contributes effectively to the overall therapy goals.
• Advise the patient on how to best take his or her medications.
as exercise, diet, and preventive steps like immunization
• Worked on AWARE, Seibel and ARGUS Safety Data-base
• Experienced in working with basic tools such as MS-Word, MS-Excel, MS-PowerPoint, Internet Explorer
and Chrome.
ACADEMIC QUALIFICATION
EDUCATION
REGISTERED IN DELHI PHARMACY COUNCIL
• B. Pharmacy (2005-2009) from ITS Paramedical College (UPTU), Recognized by PCI.
• 12th [C.B.S.E] from D.L D.A.V Modern School, New Delhi
• 10th [C.B.S.E] from D.L D.A.V Modern School, New Delhi
Projects Undertaken (DURING the course of B.Pharm )
Project Title – To Study about gout (a joint disorder) Jan 2009 - March 2009
Guide – Prof Shikha Parmar.
Objective - Management and treatment of gout.
PERSONAL DOSSIER
TECHNICAL SKILLS
3. Name : Ankush Arora
Nationality : Indian
Marital Status : Single
Gender : Male
Date of Birth : 21th
September, 1986
Mobile Number : +919654731370/ 9654776770
E-Mail : aroraankush012@gmail.com
Languages Known : Hindi, English and Punjabi
(Ankush Arora)
Place: Navi Mumbai
![Sr Pharmacist
Key Role:
• Issuing Medicine to the department as per stock level.
• Issuing Medicine to the In-Patient Department
• Checking the Supply from the vendors.
Jun 2010- July2012 Max Hospital
Pharmacist
Key Role:
• Follow the patient’s progress to determine the effects of the patient’s medications on his or her health.
• Consult with the patient’s physicians and other health care providers in selecting the medication therapy that
best meets the patient’s needs and contributes effectively to the overall therapy goals.
• Advise the patient on how to best take his or her medications.
as exercise, diet, and preventive steps like immunization
• Worked on AWARE, Seibel and ARGUS Safety Data-base
• Experienced in working with basic tools such as MS-Word, MS-Excel, MS-PowerPoint, Internet Explorer
and Chrome.
ACADEMIC QUALIFICATION
EDUCATION
REGISTERED IN DELHI PHARMACY COUNCIL
• B. Pharmacy (2005-2009) from ITS Paramedical College (UPTU), Recognized by PCI.
• 12th [C.B.S.E] from D.L D.A.V Modern School, New Delhi
• 10th [C.B.S.E] from D.L D.A.V Modern School, New Delhi
Projects Undertaken (DURING the course of B.Pharm )
Project Title – To Study about gout (a joint disorder) Jan 2009 - March 2009
Guide – Prof Shikha Parmar.
Objective - Management and treatment of gout.
PERSONAL DOSSIER
TECHNICAL SKILLS](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)