Rekha Dhaibar-Shinde
Kalyan West
Summary
I am seeking assignments in Clinical Trials, Medical Writing, Pharmacovigilance and Clinical Data Management, with a growth oriented organization, in Clinical Research Industry.
Overview
18
18
years of professional experience
Work History
Aggregate report specialist 1
IQVIA
03.2023 - 04.2024
- Company Overview: www.iqvia.com
- Draft various aggregate reports as PBRERs, Addendum statements, AddCO, PADERS
- Monitoring the compliance on daily basis for all reports drafted
- Review of call of information for various reports of team members
- Complete end to end activity in drafting the reports as per client conventions and agreed timelines and quality
- Mentor and train the new joinees in various steps of drafting reports
- Received IQVIA Impact Award in Jul 2023 for completing all trainings and daily reports with minimal supervision with good quality
- Www.iqvia.com
Assistant Manager
DdReg Pharma Pvt LTD
01.2023 - 03.2023
- Regulatory support for registration and renewal of generic products for various clients
- Drafting and review of SmPc, PIL, leaflets, artworks-foils, labels, leaflets
- Drafting and review of aggregate reports, PSURs, PBRERs, PADERs, RMPs
- Regular client coordination and call with various internal stakeholders, safety operations teams, regulatory teams
- Manage team of 10 team members, mentoring, guiding and review their day to day activities
- Draft and review of project instructions for drafting of various documents as SmPc, PILs, PADERs, PSURs, RMP
- Support to client for giving medical therapeutic expertise for launch of new product or health supplement in market
Drug Safety Specialist
Fidelity Health Services Pvt Ltd.
03.2020 - 09.2022
- Preparation and review of various types of Aggregate Reports (AR)
- Strategizing and planning for submission of ARs
- Generation of line listings and summary tabulations, referring the processed ICSR for ARs and XML from global safety database
- Liaison with client and relevant stakeholders for process enhancement, issue discussion and for any other requirement
- Generating eCTD files from Dossier Management Systems for AR submissions
- Support in other departmental activities as and when required based on professional experience, educational qualifications, and regulatory requirements
- Drafted PADERs, PSURs, PBRERs, ARs, SBRs for USA, Russia, Australia
- Reviewed ARs, SBRs, PSURs and PBRERs
Consultant Doctor
Dr Krishna's Cancer Healer Centre
10.2017 - 02.2018
- Case taking, consulting the patient, explaining about the treatment, assessing the severity of the disease and resolving the queries of patients
- All types of cancer, pre-cancer patients
- If required providing patients with diet consultation
- Keeping follow up to assess the condition of patients after taking treatment
General Practitioner and consultant Homoeopath
01.2016 - 10.2017
- Had rental clinic for general practice
- Normally was consulting around 5-10 patients in a day
- Group of patients seen were mostly ladies and children
- Has treated many skin diseases, children ailments and female complaints
Data Analyst
Cognizant Technology Services
08.2013 - 05.2015
- Write the periodic safety update report (PSUR), aggregate report (AR), summary bridging report (SBR) as per GVP module, Vol 9 and client conventions and standards for generic drugs
- Achieve 90% in drafting the reports, write narrative, draft discussion for safety issues/risk
- Identify signal from the data provided and the line listings provided for the molecules
- Write mini-PSUR's that is draft the safety issues and search literature for identification of new signal if any
- Review of the reports drafted by the other team member within the stipulated timelines
- Prepare the training material for the new associate of the project
- Eg: Need and requirement of variations ppt
- Mentor the new joiners in the project for drafting the reports
- Literature search for the efficacy, safety and identification of any new signal for the molecule
- Draft company comments and assess risk benefit ratio of the molecules
Process Trainer
Cognizant Technology Services
11.2012 - 08.2013
- Training of generic pharmacovigilance, end to end activities of pharmacovigilance right from definition of pharmacovigilance to submission to regulatory authority
- Create the activities and questionnaire for assessing the knowledge of new joinees of the organization in field of pharmacovigilance
- Create and update training material for training new joiners in the field of pharmacovigilance and medical writing
- Training for therapeutic areas as per the project requirement
- Creation of training material for therapeutic areas like 'Cardiovascular disease', 'Genetic disease', 'Ophthalmology' and 'Oncology'
- Conduct assessment and maintain the assessment record for the new joiners
- Create and update training plan for the new joiners
- Work in collaboration with operations to come with up with their training requirement
- Conduct medical writing basic trainings for the new joiners in field of medical writing
- Regularly update the training material for medical writing
- Conduct assessment for new medical writers and maintain the record as per SOP defined by the organization
- Write an SOP for allocated project as per the training need
- In collaboration with Quality team, maintain the quality record for the new joiners for the allocated project and identify the training requirement for the quarter bottom performers and help them to achieve the client's quality and TAT SLA's (Service level agreement)
Process Executive
Tata Consultancy Services
01.2009 - 10.2010
- This project is one of the best biotechnology projects
- Data processing of spontaneous Post marketed adverse events for the client working in collaboration with Wyeth
- Data processing right from data entry to completion of cases
- For all non-serious and serious spontaneous post marketed cases
- Had worked as QC (Quality check) and SME (subject matter expert) for the same project
- Being a QC, assess cases of the team, quality check for all cases- serious and non-serious of both post marketed serious as well as non-serious cases and clinical cases
- Attend calls with US- client on improvement of the cases, reporting timelines, any query from team side, etc
- Being an SME, did the submission of cases on Client database, resolve the queries of team, timely train the team for faster resolution of cases
- Had hand to hand discussion of all clinical operations and technical data, timely up gradation of standard operating procedures (SOP's) of the daily work, up gradation of user manual of the database used by the team, etc
Goldshield Group PLC
08.2007 - 12.2008
- Company Overview: A listed Euro-centric company, engaged in promoting, marketing and distributing internationally branded and generic pharmaceutical products
- Working in Post Marketing Pharmacovigilance and drug safety activities for 560 product licenses in the EEA
- Functioning as a team member in national or international assignments involving a variety of activities
- Support business development by a pro-active and reactive approach
- Work as a safety assistants/associate with an enthusiastic, supportive attitude
- Perform all tasks as may be required to complete an assignment in full & in time
- Coordinating in Pharmacovigilance activities including literature searches, PSUR preparation, spontaneous ADR management, MedDRA coding & global exchange of safety data for submission to National Competent Authorities
- One of the team members of - Global safety information processing of AEs'/ADRs'
- Collection of adverse events (AEs), recording in the country register and timely reporting of AEs /SAEs to the local regulatory authority as required
- Case processing(Data entry)- entering all the relevant information of the patient, suspect drug and the adverse drug reaction all MedDRA coded & 'case narrative writing' for Annonymised Single Patient Reports' in to the software named Basecon - safety exchange
- Also write short summary narratives for literature case
- Close monitoring on Triage activities for spontaneous & non-spontaneous cases
- Quality control on Case processing activities
- Trained for writing PSUR (Periodic Safety update reports) in accordance with the format proposed in ICH Guidelines E2C (Clinical Safety Data Management: Periodic Safety Update Reports for marketed drugs [CPMP/ICH/288/95] for MHRA and IMB regulatory authorities
- Data collation for PSUR (includes literatures cases, published study reports and serious adverse drug reactions which need to discuss in the report) and compilation of the reports for various marketed products
- Pulling out Line listing, summary tabulation of the adverse reactions and calculation of the patient drug exposure for the particular period for a particular formulation
- Working closely with various departments like the Technical, Supply chain management, Regulatory, Legal
- Harmonisation of SmPCs' and PILs' for 560 product licenses in the EEA
- Amendments in the SmPCs'and PILs' on regulatory queries and clinical expert report in PSUR
- Assisting in the overall functioning of the Global Medical Information function
- Receiving queries from various sources and providing information on time
- MHRA/EMEA updates: To review Safety updates for medicinal products for human use on EMEA/MHRA sites on a weekly basis
- A listed Euro-centric company, engaged in promoting, marketing and distributing internationally branded and generic pharmaceutical products
Medical Officer {grade VIII}
02.2007 - 07.2007
- In claim scrutiny department, assessing claim related documents, reviewing investigations whether related to the disease condition, justifying hospitalization, cutting down excess irrelevant charges of hospitalization
- Making a list of fake hospitals (i.e
- Hospitals taking excess charges, irrelevant hospitalization, excess day of stay in hospital for simple illnesses)
Cardiology associate
Quintiles Data Processing Centre
01.2006 - 12.2006
- Company Overview: It is a contract research organization located at Leela business park, Marol, Andheri (E)
- Received training on principle of interpreting ECG's (reading, measuring various parameters of ECG's)
- Brief training on cardiology anatomy and physiology
- Analyzing ECG'S, interpreting diagnosis, protocol related studies
- It is a contract research organization located at Leela business park, Marol, Andheri (E)
Education
Bachelor of Homoeopathic Medicine and Surgery -
Smt C.M.P Homoeopathic Medical College
Mumbai01.2006
Skills
- Enthusiastic learner
- Knowledge-hungry learner
- Eager to meet challenges
- Quickly assimilate new concepts
- Highly motivated
- Self-starter
- Takes initiative
- Highly adaptable
- Positive
- Open to new ideas
Training
- Workshop on ABPI code of practise, 08/01/08, Mumbai, Maharashtra
- Medicomarketing training: Regulatory guidelines for Healthcare claims, Legal basis of Healthcare claims
- Workshop on Global Literature searching, 04/01/08, Mumbai, Maharashtra
- Signal generation, training by the Deputy QPPV, 03/01/08
- PSUR- writing, 02/01/08, Mumbai, Maharashtra
- Fundamentals of Pharmacovigilance; Training by the Deputy QPPV, 11/01/07
- Data entry and case narrative writing (case processing). Training by the Deputy QPPV, 12/01/07
- MedDRA coding, training by the Deputy QPPV, 11/01/07
- Train the Trainer Cognizant Technology Solutions, 08/01/13
- Cognizant's star performer- WOW and OPAL award, 02/01/15
- Fidelity Health Services star performer award certificate, 12/01/20
References
On Request.
Statementofpurpose
I am seeking assignments in Clinical Trials, Medical Writing, Pharmacovigilance and Clinical Data Management, with a growth oriented organization, in Clinical Research Industry.
Timeline
Aggregate report specialist 1
IQVIA
03.2023 - 04.2024
Assistant Manager
DdReg Pharma Pvt LTD
01.2023 - 03.2023
Drug Safety Specialist
Fidelity Health Services Pvt Ltd.
03.2020 - 09.2022
Consultant Doctor
Dr Krishna's Cancer Healer Centre
10.2017 - 02.2018
General Practitioner and consultant Homoeopath
01.2016 - 10.2017
Data Analyst
Cognizant Technology Services
08.2013 - 05.2015
Process Trainer
Cognizant Technology Services
11.2012 - 08.2013
Process Executive
Tata Consultancy Services
01.2009 - 10.2010
Goldshield Group PLC
08.2007 - 12.2008
Medical Officer {grade VIII}
02.2007 - 07.2007
Cardiology associate
Quintiles Data Processing Centre
01.2006 - 12.2006
Bachelor of Homoeopathic Medicine and Surgery -
Smt C.M.P Homoeopathic Medical College