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Neelam Ale 12 July
Neelam Ale 12 July
Mahaparale
neelam.mahaparale@gmail.com
SUMMARY
I have 2.5 years of experience in Clinical research with skills in Clinical operations,
Pharmacovigilance & Data management which gave me excellent knowledge of GCP and
ICH guidelines, Microsoft Windows, Microsoft office.
My work for ‘Adverse Drug Reaction (ADR) Monitoring Program’ governed by WHO and
Drug Controller General of India (DCGI), helped me gaining exceptional knowledge in
Pharmacovigilance domain.
As I have worked for hospital as well for CRO has good knowledge of working procedures for
both Principal Investigator and Sponsor. This also helped me gaining the best knowledge on
GCP and management of trial related issues. My knowledge is excellent not only in clinical
but also in Preclinical studies and patent law.
Clinical operations:
• Feasibility survey
• Assistance in preparation of local study related documentation including
Clinical Study Timelines, recruitment plans and Informed Consent Form
• Support for planning and execution of studies
• Coordinate supply of clinical study equipment/ drugs
• Review adherence to SOP and GCP
• Submission and archival of study documents
• Conducting trainings on SAE management
Data Management:
• Preparation of study related documentation & Timeline,
• To ensure Statistical Analysis Plan (SAP) requirements
• SAE Reconciliation
• Coding of adverse events (MedDRA)
Medical Coding - Coding of concomitant drugs (WHODRUG)
• Data Validation and Query Management
• Periodic validation of CRF data
• Conducting trainings on SOP for Clinical data coding & Reconciliation
PROFESSIONAL EXPERIENCE
1) Mapyn (January 2009- till date)
Designation: Executive HR ADMN
• Performance management
• Rewards management
• Operations supporting and monitoring
• ‘Adverse Drug Reaction (ADR)’ Monitoring Program governed by WHO and Drug
Controller General of India
• Drug Information Services.
• Assistance in a Clinical Trial.
• Therapeutic Drug Monitoring
- Anti-Epileptic Drugs
- Immunosuppressant (Cyclosporine)
• PEG estimation in Urine using Spectrophotometer.
• Storage, Dispensingto subjects and Retrieval of IP containers from Subject
• Disposal Destruction of IP
12 July 2010 page 2 of 4
Mrs. Neelam Y. Mahaparale
neelam.mahaparale@gmail.com
• Related documentation
Clinical Research Experience:
• Invetory Management
• Storage, Dispensing, Destruction of IP
• Related documentation
Industrial Training
• Wyeth Lederle, Ghatkopar Mumbai.
Workshop Attended:
• 2 Days state level work shop on Intellectual property rights – a pharmaceutical
perspective 23th& 24th Feb. 2010
• Pharmacovigilance- a solution to drug safety, 13th Feb. 2010
• Pharma Pulse confluence Advanced Clinical research & GCP Workshop, 26th&
th
27 Feb. 2005
• Pharma Pulse confluence Pre-Clinical research, 24th& 25th Feb. 2005
• ICMR Workshop on Clinical Research Methodology, 2004.
Personal information
Address for Correspondence 4, Tulips A1part 2, Sukhwani campus
Vallabhnagar Pimpri
Pune 411 018
Nationality Indian
Education
Course Year of Subject / Institution / University
Passing Specialization
B. PHARMACY 2002 Pharmaceutical Bharati Vidyapeeth’s College
Sciences of Pharmacy/ Mumbai
PGDCRP 2005 Clinical Operations, R. N. Ruia College-PEXA
(Post Graduate Diploma Regulatory Affairs, (Pharmaceutical Experts
in Clinico-Regulatory and Patent Law. Association) / Mumbai.
Patents)
Basic Good Clinical 2010 Basic GCP African Malaria Network Trust
Practice (AMANET)
Basic Health Research 2010 Ethics in Clinical African Malaria Network Trust
Ethics research (AMANET)
Advanced Health 2010 Ethics in Clinical African Malaria Network Trust
Research Ethics (Ongoing) research (AMANET)
Languages Known
References
• Dr. Urmila Thatte (Clinical Pharmacology Dept. K.E.M.Hospital Parel, Mumbai)
• Dr. Mahajan (Cardiology Dept, Sion Hospital, Mumbai)
• Kalpana Antony (Senior Clinical Project Manager, PATH) Tel: 9833734513
• Yashesh Mehta (Sr. Director Operations at inVentiv Health) Tel.9769003070