Hi, I’m
Jisha Shamsudeen
Assistant Professor
Trivandrum
Summary
- Profile Summary: Pursuing career in Clinical Research and Pharmacovigilance for around 7years
- Certified in EDC and phase inform for Clinical Research Coordination organized by Novo Nordisk
- Skilled in ensuring regulatory compliance, dossier, documentation and enhancing operational efficiency Followed QMS policies, procedures and practices
- Participate in Good Clinical Practices Course, organized by Novo Nordisk, USA
- Skilled in maintaining accurate records including patients’ profiles, inventory, and pharmacy files MOH Qualified Registered Pharmacist
- Einter-personal, communication and team coordination skills with abilities to work in a high pressurized environment Core competencies Research & Development (Pharmaceuticals) Clinical Programs Liasioning and Coordination Regulatory & Quality Assurance Storage Management Pharmaceutical Assessment Drug Examination Medical Writing Experience Soft Skills Analytical T
Overview
15
years of professional experience
30
years of post-secondary education
1
Certification
Work History
Dale View College Of Pharmacy And Research CenterTrivandrum
Assistant Professor
11.2022 - Current
Job overview
- Performed research to serve as basis for academic writing for publication.
- Provided logical integration and continuity of academic skills training and assessment across 4-year curriculum.
- Stood in for professors and teachers in absences, lecturing or providing course material on Pharmaceutical Chemistry based on lesson plans.
- Assisted professors and s administrators with continuous development, review, planning and outcomes evaluation to measure performance.
NexgensmTrivandrum
Research Analyst
04.2022 - 09.2022
Job overview
- Developed algorithms and software to automate data gathering and analysis processes.
- Analyzed large volume of data to identify patterns, trends and correlations.
- Conducted in-depth qualitative and quantitative research to identify trends and generate insights.
Healthminds Consulting Private
Drug Safety Associate
01.2021 - 01.2022
Job overview
- Functioned as a Drug Safety Associate; involved in case processing at QC level for regulatory submission in Vaccine monitoring study
- Gained extensive experience on ISS tool
- JISHA SHAMSUDEEN
- Scaling new heights of success and leaving a mark of excellence at each step; targeting assignments as Pharmacist with an organization of high repute
ICON Clinical Research
Drug Safety Associate
01.2020 - 01.2021
Job overview
- Worked as a drug safety associate into the role of case processing for regulatory submission in various projects across the globe
- Leveraged hands on experience in Argus, Medidata Rave, Aris G, Involved in the regulatory submission completer working with some great projects throughout the year in both Clinical Trial and Cases
- Shouldered the responsibility of maintaining patients’ profiles, inventories, pharmacy files, and other necessary records
- Played a key role in minimizing the pharmacy waste through executing improved protocols for inventory and storage management
- Provided advice on the dosage of medicines and the most appropriate form of medication
JOTHYDEV’S Diabetes and Research Center
Research Associate
06.2019 - 12.2019
Job overview
- Roles and Responsibilities:
- Worked as a research associate for various papers and clinical programs in the center, contributed as a co-author for an abstract presented in ATTD in the year 2020
- Inprocess CRO, -CRO for Sponsor Team of ISCHEMIA GLOBAL TRIAL
IprocessBangalore, Kerala
Clinical Research Coordinator
11.2014 - 04.2015
Job overview
- The study evaluate the efficacy of interventional management over conservative management of Cardiovascular Diseases, recruited in Calicut Medical College, India Department of Cardiology under the guidance of the head of the Department Dr
- (Cardio), FRCP, FACC, FESF,FSCAI
- Roles and responsibilities:
- Identified the potential subjects for the project and worked close liaison with the site study and sponsor team
- Maintained patient retention strategy and boosted randomization of targets
- Participated in audits and SAE Management on a timely basis with regulatory body of the sponsor team
- Site became one of the most efficient sites for cardiovascular management globally maintaining first rating position in global Ischemia
- Newsletter
JOTHYDEV’S Diabetes and Research Center
Clinical Research Associate
12.2008 - 03.2012
Job overview
- Roles and responsibilities:
- Executed Clinical Study related time bound projects with emphasis on patient care and management
- Lead as the Clinical Coordinator in a study comparing the efficacy of two insulins
Education
Trivandrum Medical CollegeTrivandrum
Master of Pharmaceutical Chemistry from Medicinal And Pharmaceutical Chemistry
02.2012 - 02.2014
University Overview
- Master dissertation project published as a paper in International Journal of Pharmaceutical Sciences
- Carried ot the duties of clinical Toxicologicist in Trivandrum Medical College as internship duty
- Received stipend following admission to the course through general merit
- Graduated with distinction
Dale View College of Pharmacy And Research CenterTrivandrum
Bachelor of Pharmacy from Pharmaceutical Sciences
03.2003 - Current
University Overview
- Carried ot internship for six months in the production unit in Hindustan Latex, Peroorkada as part of the University Programme
- was an active member in Essay Competition
- Had meticulous interest in laboratory assignments in Pharmaceutical Chemistry
- Graduated with first class 72%
Raja Kesavadas NSS Higher Secondary SchoolTrivandrum
Higher Secondary Education from Science And Maths
03.2001 - 04.2002
University Overview
- Passed out with first class
Carmel Girls High SchoolTrivandrum
Secondary School Leaving Cerificate from All Subjects
03.1999 - 03.2000
University Overview
- Passed out with distinction
Indian School, Ras Al KhaimahRas Al Khaimah , UAE
Schooling Till 6th Standard from All Subjects
01.1989 - 09.1994
Skills
Classroom presentations
Accomplishments
- NN 304-1768:-Clinical Data Coordinator in a six month retrospective study of telemedicine based reporting-Clinical coordinator in a study evaluating the cardiovascular outcomes in patients taking Sitagliptin
- Successfully executed Medical Writings of abstracts in American Diabetes Association (ADA), poster in International Diabetes
- Kerala Institute of Medical Sciences (KIMS) , Clinical Research Observer June’08-Nov’08
- Roles and responsibilities:
- Assessed the feasibility of protocol
- Executed the trial related procedures with strict adherence to the protocols
- Coordinated the regulatory agencies and institutional ethics committee, site and CRO/Sponsor
- Informed consent procedure, followed up with the patients
- Managed the logistics related to the study and Electronics Data Capturing
- Monitored data in the e-crf and paper crf and cross verification with the source notes
- Publications
- Use of Insulin Pumps in India
- Suggested Guidelines Based on Experience and Cultural Differences – Paper published in the Journal Diabetes Technology and Therapeutics in 2010
- Requirement of High Dosage of Insulin in Previous users of Glibenclamide with Uncontrolled Diabetes- Abstract published in American
- Diabetes Association in the year2009
- Role of Continuous Glucose Monitoring in Modifying Diet and Lifestyle in Diabetes Subjects Abstract published in American
- Diabetes Association in the year, 2009
- Low Compliance of Statins in Rural Population of Kerala- Poster presented in International Diabetes Congress held in Montrealin the year 2009
- Achievements and Trainings
- Insilico design synthesis and pharmacological screening of novel derivatives of 2Aminothiazole and Oxadiazole, thesis submitted to the
- Kerala University of Health Sciences in partial fulfillment of award of the degree of Masters in Pharmaceutical Chemistry done in Collegeof Pharmaceutical Sciences, Trivandrum in the year 2014
- Synthesis and evaluation of anti-inflammatory activity of novel derivatives ofminothiazole and Oxadiazole - Paper has been published in IJPSR (International Journal of Pharmaceutical Sciences and Research) inhttp://www.ijpsi.org/Vol3(5)-version-2.html
- Participated in training workshop for Good Pharmacy Practice Organized by Indian Pharmaceutical Association supported by
- Central Drugs Standard Organization and WHO Indian Country Office
- Certified in EDC Informed and Phase Inform for Clinical Research Coordinators organized by Novo Nordisk
Certification
KUHS Faculty Certification
Timeline
Assistant Professor
Dale View College Of Pharmacy And Research Center
11.2022 - Current
Research Analyst
Nexgensm
04.2022 - 09.2022
Drug Safety Associate
Healthminds Consulting Private
01.2021 - 01.2022
Drug Safety Associate
ICON Clinical Research
01.2020 - 01.2021
Research Associate
JOTHYDEV’S Diabetes and Research Center
06.2019 - 12.2019
Clinical Research Coordinator
Iprocess
11.2014 - 04.2015
Trivandrum Medical College
Master of Pharmaceutical Chemistry from Medicinal And Pharmaceutical Chemistry
02.2012 - 02.2014
Clinical Research Associate
JOTHYDEV’S Diabetes and Research Center
12.2008 - 03.2012
Dale View College of Pharmacy And Research Center
Bachelor of Pharmacy from Pharmaceutical Sciences
03.2003 - Current
Raja Kesavadas NSS Higher Secondary School
Higher Secondary Education from Science And Maths
03.2001 - 04.2002
Carmel Girls High School
Secondary School Leaving Cerificate from All Subjects
03.1999 - 03.2000
Indian School, Ras Al Khaimah
Schooling Till 6th Standard from All Subjects
01.1989 - 09.1994
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