Anuja Kadam is seeking a position that utilizes her pharmacy expertise. She has over 2 years of experience as a Drug Safety Associate conducting pharmacovigilance activities including adverse event reporting, coding, and case review. She holds a B.Pharmacy and M.Pharmacy in Pharmaceutics from Bharati Vidyapeeth Deemed University. Her skills include clinical trial documentation, medical coding, and pharmacovigilance software.
Pharmacovigilance (gpv p) training in india Radhika Nagare
Pharmacovigilance is the approach related to making an assessment, detection, understanding and prevention of inappropriate effects or any other problems to drug-related . So those working in the field of pharmacovigilance must have a good working knowledge of the principles of drug safety, regulations and proactive strategies for risk management. So people who want to pursue a clinical research career, can take up Pharmacovigilance training for adding value to their qualification.
Pharmacy Technician Training Program Near Me in Dallas & Arlington, TX | CCI ...CCI Training Center
Searching Certified Pharmacy Technician Training Program Near me in Dallas & Arlington, TX. Join CCI best Pharmacy Technician program with flexible class & online hours. https://www.ccitraining.edu/medical-healthcare/pharmacy-technician/
Dear students get fully solved assignments
Send your semester & Specialization name to our mail id :
help.mbaassignments@gmail.com
or
Call us at : 08263069601
HySynth Biotechnologies’s Pharmacovigilance group provides a range of tailored Pharmacovigilance (PV) and Biovigilance (Hemovigilance) services that can effectively address the needs of biopharmaceutical companies of all sizes.
With people over 10 years of medical, technology and compliance expertise, we are able to provide diligently managed, flexible and cost-effective solutions.
With a full suite of scalable and flexible solutions, we can provide tools and techniques to achieve patient safety, regulatory compliance and long-term strategic advantage.
Our service packages are customized as per requisite of the organization and delivered through a lean operational model which includes, Triage till Medical Review, Case Processing, Case Reporting, Single Case Narrative writing, Aggregate Report writing, Literature Search, etc.
Medical Analysis:
- AE and SAE evaluations
- MedDRA and WHO-DD Coding
- SAE narrative writing
- Causality and Labeling Assessments
- Physician medical review and signal detection
- Literature reviews and summaries
- Updating CCDS and other Core documents
Regulatory Reporting:
- Expedited Reporting: Generation of MedWatch 3500A/CIOMS I forms
- Preparation of periodic safety update reports (PSURs) and periodic adverse drug experience reports (PADERs)
- Prompt notification of potential expedited IND, alert, and suspected unexpected serious adverse reaction (SUSAR) reports via E2B and Paper mail.
ICSR Processing:
The processing of individual case safety reports (ICSRs) originating from various sources which includes,
Post-marketing non-solicited/ Spontaneous reports
Clinical Reports
Special reports (Medico-legal, Literature & E2B)
Related Sources
Following established guidelines, data from source documents sent by clients are processed (data entry, MedDRA coding and safety narrative) in to a Drug Safety/Pharmacovigilance database, after a duplicate check.
This involves an initial triage followed by Data processing and a subsequent medical review by a physician. After the review process, the case reports are submitted to the regulatory authorities/business partners.
HySynth’s people have extensive experience across all case types and have worked with all commercially available drug safety databases, such as Argus Safety, ARISg, Empirica Trace and proprietary client databases.
Using JReview to Analyze Clinical and Pharmacovigilance Data in Disparate Sys...Perficient, Inc.
Sponsors and CROs naturally rely on various clinical and safety systems from a multitude of software vendors. However, continuously accessing disparate sources for the reporting, analysis, and monitoring of data can be a treacherous undertaking, if you don't have a solution that connects to them right out of the box.
That's where JReview comes in. For almost two decades, life sciences companies, research organizations, in addition to the government, have relied on JReview for the comprehensive analysis and monitoring of clinical and pharmacovigilance data.
The analytics solution works with many Oracle Health Sciences applications, including Argus Safety, Oracle AERS, Oracle Clinical (OC), Remote Data Capture (RDC), Thesaurus Management System (TMS), InForm, Life Sciences Data Hub (LSH), and Clinical Development Center (CDC). JReview also works with non-Oracle solutions, such as ARISg, Medidata Rave, and SAS Drug Development.
In this slideshare, you will learn:
The features and benefits of JReview, including the new functionality in v10.0 (e.g., risk-based monitoring analytics reporting on the clinical data itself, etc.)
Benefits of using JReview for:
Reporting and query of your clinical data
Supplying internal and/or external users/sponsors information
Providing a secure way for your internal users and/or sponsor users to access the clinical data
Examples of how customers use JReview with OC/RDC
The implementation process and options
A common goal of life sciences companies is to capture essential adverse event data efficiently. The use of automated systems to document and track this information is proving to be essential in the safety field.
Perficient’s Dr. Rodney Lemery, director of safety and pharmacovigilance, reviewed various features of Oracle’s Argus Safety solution that can assist you in your safety and pharmacovigilance practices.
Pharmacovigilance (gpv p) training in india Radhika Nagare
Pharmacovigilance is the approach related to making an assessment, detection, understanding and prevention of inappropriate effects or any other problems to drug-related . So those working in the field of pharmacovigilance must have a good working knowledge of the principles of drug safety, regulations and proactive strategies for risk management. So people who want to pursue a clinical research career, can take up Pharmacovigilance training for adding value to their qualification.
Pharmacy Technician Training Program Near Me in Dallas & Arlington, TX | CCI ...CCI Training Center
Searching Certified Pharmacy Technician Training Program Near me in Dallas & Arlington, TX. Join CCI best Pharmacy Technician program with flexible class & online hours. https://www.ccitraining.edu/medical-healthcare/pharmacy-technician/
Dear students get fully solved assignments
Send your semester & Specialization name to our mail id :
help.mbaassignments@gmail.com
or
Call us at : 08263069601
HySynth Biotechnologies’s Pharmacovigilance group provides a range of tailored Pharmacovigilance (PV) and Biovigilance (Hemovigilance) services that can effectively address the needs of biopharmaceutical companies of all sizes.
With people over 10 years of medical, technology and compliance expertise, we are able to provide diligently managed, flexible and cost-effective solutions.
With a full suite of scalable and flexible solutions, we can provide tools and techniques to achieve patient safety, regulatory compliance and long-term strategic advantage.
Our service packages are customized as per requisite of the organization and delivered through a lean operational model which includes, Triage till Medical Review, Case Processing, Case Reporting, Single Case Narrative writing, Aggregate Report writing, Literature Search, etc.
Medical Analysis:
- AE and SAE evaluations
- MedDRA and WHO-DD Coding
- SAE narrative writing
- Causality and Labeling Assessments
- Physician medical review and signal detection
- Literature reviews and summaries
- Updating CCDS and other Core documents
Regulatory Reporting:
- Expedited Reporting: Generation of MedWatch 3500A/CIOMS I forms
- Preparation of periodic safety update reports (PSURs) and periodic adverse drug experience reports (PADERs)
- Prompt notification of potential expedited IND, alert, and suspected unexpected serious adverse reaction (SUSAR) reports via E2B and Paper mail.
ICSR Processing:
The processing of individual case safety reports (ICSRs) originating from various sources which includes,
Post-marketing non-solicited/ Spontaneous reports
Clinical Reports
Special reports (Medico-legal, Literature & E2B)
Related Sources
Following established guidelines, data from source documents sent by clients are processed (data entry, MedDRA coding and safety narrative) in to a Drug Safety/Pharmacovigilance database, after a duplicate check.
This involves an initial triage followed by Data processing and a subsequent medical review by a physician. After the review process, the case reports are submitted to the regulatory authorities/business partners.
HySynth’s people have extensive experience across all case types and have worked with all commercially available drug safety databases, such as Argus Safety, ARISg, Empirica Trace and proprietary client databases.
Using JReview to Analyze Clinical and Pharmacovigilance Data in Disparate Sys...Perficient, Inc.
Sponsors and CROs naturally rely on various clinical and safety systems from a multitude of software vendors. However, continuously accessing disparate sources for the reporting, analysis, and monitoring of data can be a treacherous undertaking, if you don't have a solution that connects to them right out of the box.
That's where JReview comes in. For almost two decades, life sciences companies, research organizations, in addition to the government, have relied on JReview for the comprehensive analysis and monitoring of clinical and pharmacovigilance data.
The analytics solution works with many Oracle Health Sciences applications, including Argus Safety, Oracle AERS, Oracle Clinical (OC), Remote Data Capture (RDC), Thesaurus Management System (TMS), InForm, Life Sciences Data Hub (LSH), and Clinical Development Center (CDC). JReview also works with non-Oracle solutions, such as ARISg, Medidata Rave, and SAS Drug Development.
In this slideshare, you will learn:
The features and benefits of JReview, including the new functionality in v10.0 (e.g., risk-based monitoring analytics reporting on the clinical data itself, etc.)
Benefits of using JReview for:
Reporting and query of your clinical data
Supplying internal and/or external users/sponsors information
Providing a secure way for your internal users and/or sponsor users to access the clinical data
Examples of how customers use JReview with OC/RDC
The implementation process and options
A common goal of life sciences companies is to capture essential adverse event data efficiently. The use of automated systems to document and track this information is proving to be essential in the safety field.
Perficient’s Dr. Rodney Lemery, director of safety and pharmacovigilance, reviewed various features of Oracle’s Argus Safety solution that can assist you in your safety and pharmacovigilance practices.
This training course on Drug Safety and Pharmacovigilance designed to give pharmaceutical and biologic companies operating in the U.S. and EU an understanding of product safety and regulatory compliance.
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
working in Quality assurance department in Qualification and validation department.
involve in new equipment qualification like multi connected tank ( Skid).
involve in media fill activity and investigation.
involve in qualification of HVAC.
involve in new facility startup activity.
“Pharmaceutical Quality Matrices in determining overall state of Quality and ...Marcep Inc.
Introduction to Quality Matrices
•What is Quality metrics
Background&Glossary
•Modernization of Regulatory Oversight of Drug Quality and Promotion of Post-Approval Improvements
•Use of Quality Metrics by FDA for Risk-Based Inspection Scheduling and Prediction of Drug Shortages
Legal authority
•Records Associated with the Process Validation Lifecycle and PQS Assessment
•Authority to Inspect Records and Request in Advance of or In Lieu of an Inspection
The Use of Quality Metrics and Effect of Non-Reporting
•How FDA Intends to Use Quality Metrics
•Effect of Non-Reporting
Group Discussion:
Implementing Trending of Quality Indices in Your Organization
The importance of the right culture and people
• Role of leadership in trending of Quality Indices
• Developing anonline data base for Quality Indices
•Analysis, interpretation and reporting of Quality Indices
The Process Flow
• Establishing the ground rules, procedures, forms and mechanismfor data collection for Quality indices
• Determining responsibilities and roles for the implementation of trending of Quality Indices
Starting the Quality Indices Management Process
•Review of Quality Indices and Gap evaluation
•Preparation of Data bases for Data acquisition
•Collection data for completeness and Accuracy
•Processing and Reporting of Quality Metrics
Day Two
Reporting of Quality data and Calculation of Quality Metrics
• Who Reports and Who May Contribute to the Report
• Quality Metrics that FDA Intends to Calculate
• What Quality Data Would Be Reported
• How to Report Quality Data to FDA
Instructions for Quality Metric Data Submission
•Worksheet for Data Tables
•Product Specific Information
•Mandatory Data •ICH Q9
•Optional Metrics
Recognizing and Understanding the Trending of Quality Indices
Working Session, I:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis on a given data. Each group will present theresults of its analysis
Working Session II:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis and propose a Quality metric by using Risk Based approach for the specific set of data. The results of the analyses willbe shared in the class.
Complexities of Implementation Quality Metrics
•Overcoming the pitfalls
•Benefits and Risks
General Discussion and Questions
1. RESUME
ANUJA KADAM
C-5/12/3:1, Sector: 5, Tulshi niwas,
C.B.D- Belapur, Navi Mumbai
Email id: anuja.kadam91@gmail.com
Contact No.: +91-8796972156
Objective
To contribute my expertise of pharmacy profession through effective use of skill,
alertness, analytical ability and efficacy in best possible way for the betterment of the
organization and self.
Area of Intrest
Pharmacovigilance
Clinical trials
Work Experience
Drug safety associate (July 2015-present): working as Drug safety associate
Pharmacovigilance in Cognizant Technology Solution Pvt. Ltd, Mumbai.
Training and Workshops: Completed Fundamentals of Pharmacovigilance
training, Pharmacovigilance online course and SEP training.
Work Profile and Responsibilities:
1. Hands on experience of ARISg Version 8.1 database.
2. Review of source documents including physician’s medical records/pharmacy
records/complaints received from marketing programs etc. (clinical trial and
spontaneous case).
3.Data Entry of the adverse events report (AE) form source docs including
patients demographical data, suspect and concomitants, narrative, selection and
detailing of adverse events, action taken, De-challenge and Re-challenge, medical
history and diagnostic details.
4. Coding of Suspect and Concomitant drugs using Company and WHO-DRUG
dictionaries.
5. Coding of verbatim terms using MedDRA for patient history, investigations,
product indication and event term.
6. Seriousness determination and Causality assessment.
7. Listedness assessment of adverse events (AE) using various labelling
documents.
2. 8. Delivering the ICSR on various case types including Spontaneous, NTA study,
Compassionate use cases and Discharge summary.
9. Quality Review (PQC) of serious and non-serious cases.
10. Writing medically relevant safety narrative of cases and checking the
completeness and accuracy.
Educational Details
class University Year of Passing Percentage
10th SSC Bharati vidyapeeth High School,
Navi Mumbai
2007 75%
12th HSC Bharati vidyapeeth High School &
Jr.college, Navi Mumbai
2009 60%
B. Pharmacy Bharati vidyapeeth Deemed
university,
Poona college of Pharmacy, Pune
June-2013 63.48%
M. Pharmacy
[Pharmaceutics]
Bharati vidyapeeth Deemed
university,
Poona college of Pharmacy, Pune
August-2015 SGPA-8.32
Professional back ground
A. In plant training - Elder Pharmaceuticals Mumbai [June-2012]
Tablet
Dept.
Liquid
Dept.
Ointment
Dept.
Capsule
Dept.
Stores
Dept.
Packing
Dept.
QC/QA
Dept.
ADL
(F&D)
B. Conferences and Seminar:
National Conference:
National conference on Pharmaceutical Innovation for Domestic and Advanced
Market: A Path Dependant Regulatory Approach held in September 2013
International conference :
14th International Symposium on Advances in Technology and Business Potential of New
Drug Delivery System, organized by Controlled Release Society- Indian Chapter held in
February 2015
Seminars :
1. Industry Institute Partnership Cell &Septech Marketing (India) Pvt. Ltd. (2013)
2. Quality Improvement Programme on Recent Advances in Pharmaceutical
Formulation Technology held in October 2013
3. State Level Workshop on Flash Chromatography, October 2013
3. C. ResearchProject Dissertation Topic: Folic acid-chitosan conjugated Paclitaxel loaded
Nanocochleates for breast Cancer Targeting
Computer Skills
Operating Systems: Windows XP/ 7/ 8, XP, Internet Applications
Software’s:MS Word, MS Excel, Adobe Reader, Photoshop.
Extracurricular activities
street play for General Awareness - Jan 2013
Pharmacy Cup 2009-2010
National pharmacy week: November 2012 and November 2013
NSS Camp: 7 days residential camp at Lawale from 27/12/2010 to 02/01/2011
Fashion show – Jan 2014
Blood donation camp – August 2011, September 2012.
Personal Details
Nationality: Indian
Date of Birth: 31/07/1991
Languages Know: English, Hindi, Marathi, Gujarati
Strength
Willing to Learn
Can work as a part of team
Good Listener
I hereby declare that, all the above information is true and correct to the best of my
knowledge and belief
Place -Navi Mumbai
Date – 09/Mar/2016 Anuja Kadam