Mrs. Neelam Y.

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.

To enlist some of work responsibilities:

Pharmacovigilance:
• Medical monitoring plan writing
• Operational support in AE management to Clinical Operations group
• SAE collection, evaluation, classification and reporting
• Medical Monitoring Plan writing
• SAE reconciliation
• Conducting trainings on SOP for Pharmacovigilance

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

Pharmacist (Drug Supply Management):

• Invetory Management of IP.
• Storage, Dispensingto subjects and Retrieval of IP containers from Subject
• Disposal Destruction of IP
• Related documentation

PROFESSIONAL EXPERIENCE
1) Mapyn (January 2009- till date)
Designation: Executive HR ADMN

• Recruitment and Selection 1st line interview

• Work force planning

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Mrs. Neelam Y. Mahaparale
neelam.mahaparale@gmail.com

• Performance management
• Rewards management
• Operations supporting and monitoring

2) Interac co. Ltd. (April 2006-Jun2007) Tochigi Ken, Japan.

Designation: ELT (English Language teacher)

• Primary Elementary & High school English Teacher

3) Reliance Clinical Research Services Pvt. Ltd.

(December 2004- April 2006)
Designation: Executive Medical affairs
(Pharmacovigilance Associate & Clinical Data Coder)

Clinical Research Experience:

Indication of study / Role(s) in study

Disease
Oncology Safety Officer/Pharmacovigilance Associate
(SAE collection, evaluation, classification, and reporting)
Clinical data coder (Coding clinical data SAE reconciliation)
Oncology Safety Officer /Pharmacovigilance Associate
(SAE collection, evaluation, classification, and reporting)
Oncology Safety Officer/ Pharmacovigilance Associate
(SAE collection, evaluation, classification, and reporting)
Probiotic formulation in Safety Officer/ Pharmacovigilance Associate
Nephrology (Medical Monitoring Plan writing, SAE collection, evaluation,
classification, and reporting)
OTC product in Pharmacovigilance Associate
Osteoarthritis (MMP Writing, SAE collection, evaluation, classification, and
reporting))
Ophthalmology Pharmacovigilance Associate
(SAE collection, evaluation, classification, and reporting)
Vaccines Pharmacovigilance Associate
(Medical Monitoring Plan writing)
Cardiology Pharmacovigilance Associate
(Medical Monitoring Plan writing)
Infectious Diseases Pharmacovigilance Associate
(Medical Monitoring Plan writing)
Respiratory Feasibility
Wound healing Clinical Data Coding and SAE Reconciliation
Ophthalmology Clinical Data Coding and SAE Reconciliation

4) Clinical Pharmacology Department, Nair Hospital, Mumbai.

(From January2004 to December2004)
Designation: Research Associate.

• ‘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
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Mrs. Neelam Y. Mahaparale
neelam.mahaparale@gmail.com

• Related documentation
Clinical Research Experience:

Indication of study / Study type and phase Role(s) in study

Disease
Diabetes Mellitus Phase I, ICMR sponsored Study Coordinator
Alcoholic Cirrhosis Phase III, CDRI Sponsored Study Coordinator

5) Byculla Pharmacy & Drug store

(From July 2003 - January2004)
Designation: Registered Pharmacist

• 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

Tel: 91-9881 108 104

Email Address neelam.mahaparale@gmail.com

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)

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Mrs. Neelam Y. Mahaparale
neelam.mahaparale@gmail.com

Languages Known

• English Business to Native level

• Japanese Basic level
• Hindi Native level
• Marathi Native level

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

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