15/3 Karela Bagh Lal Calony Allahabad UP- 211003

NEERAJ SINGH

Contact: +91-7379315000, +91-9718808560; Email Id:

ASPIRING PHARMACOVIGILANCE/CLINICAL RESEARCH PROFESSIONAL

Aspiring to work in a challenging environment demanding all my skills and efforts to explore and realize my potential and contribute to the development of organization with impressive performance in the field of Medical Writing, Regulatory Affairs, Pharmacovigilance / Clinical Research & Development/Data Management.

PROFILE

 Pass out M.Sc in Clinical Research from Apeejay Stya University backed by B.Sc from Kanpur University; have deep passion and high energy level to pursue a successful career by blending skills and knowledge towards the accomplishment of organizational and personal goals.

 Possess knowledge of Clinical Trial, Pharmacovigilance, Regulatory Requirements, Drug and Cosmetic Act-Schedule Y, USFDA, ICH GCP, Indian GCP Guidelines, Principles of Pharmacology & Drug Discovery & Development, European Union rules and regulations, CRF Design, Proc SQL, Working with SAS Datasets, Dates, Collecting Adverse Event Data, Medical Coding, SAS Macro Language, Components of SAS, Basic Statistical Procedures, Data Management Plan, UAT (User Acceptance Testing), Database QC, Documents, Tracking CRF Data, Guidelines used in CDM and concerned authorities regulating the clinical trials.

 Interested in the fields of Medical Writing, Clinical Trial, Pharmacovigilance and Regulatory Affairs

 Sound knowledge about research methodology, clinical evaluation, regulatory requirements of clinical trials and developed sharp project management skills.

 Self-motivated, hardworking and goal-oriented with a high degree of flexibility, creativity, resourcefulness, commitment and optimism. Good communication & presentation skills with the ability to perform above expectations.

diploma & certificate courses:

 Post Graduate Diploma on Clinical Data Management, 2011 from Cliniminds (Delhi)

 Open Access Certificate Course “Intro to Clinical Trials and Drug Development”

 Open Access Certificate Course “Documentation and Record Keeping (GMP)”

 Open Access Certificate Course Good Clinical Practice , PharmaXM

 Open Access Certificate Course “Circulating Tumor Cells as Biomarkers”

software handled:

 Statistical Analytical Software (SAS)

 Statistical Package for Social Science (SPSS)

 Chem Draw & JChem (for excel)

 Mega 5 Bioinformatics

TECHINICAL SKILLS AND INSTRUMENT HANDLED

 Micro-Biology (DNA isolation DNA Cloning PCR MOLECULAR HYBRIDIZATION)

 Bio-Analytical (Different chromatographic separation methods including Affinity chromatography, Ion exchange chromatography, Column chromatography, Thin layer chromatography, SDS-PAGE, ELISA, Western Blotting)

 Bio-Informatics (NCBI, EMBL databases, Sequence alignment studies using and aware of the use of Softwares BLAST, FASTA)

Clinical research knowledge

 ICH GCP, Indian GCP Guidelines.

 Drug and Cosmetic act-Schedule Y, USFDA, European Union rules and regulations.

 Principles of Pharmacology & Drug Discovery & Development.

 CRF Design, Protocol Preparation

 Data Entry, Remote Data Entry.

 Medical Coding.

 Clinical Database & Types.

 Data Management Plan.

 Electronic Data Capture.

 Tracking CRF Data.

 Managing Lab Data.

 Collecting Adverse Event Data.

 Creating Reports and Transferring Data.

major subjects studies at post-graduation:

 Clinical Trial & Pharmacogenomics

 Clinical Data Management

 Medico informatics

 Disease Biology & Therapeutics

 Medicinal Chemistry

 Biopharmaceuticals

 Molecular Biology & Genetics

 Metabolism & Metabolomics

 Biostatistics

 Pharmacovigilance

 IPR,RA and Intro to Management

 Medical Writing

Technical Skills

 MS Word, Excel, Power point

 Basics of Internet

EDUCATIONAL QUALIFICATIONS

M.Sc (Clinical Research Management), 2013

Apeejay Stya University; 3.3

PG Diploma in Clinical Data Management, 2011

Cliniminds, New Delhi; 77%

B.Sc, 2010

Kanpur University; 55%

Intermediate 2007

UP Board; 61.3%

X 2005

UP Board; 58%

Seminars Attended

International Symbiosis Micro-Biology Seminar- JNU 11-13 March 2011

UGC SAP DRS-I sponsored National Seminar on Proteomics Based Biomarkers for Animal and Plant Diseases Jamia Hamdard 2013

Projects Undertaken

 Identification & Classification of Bacteria Form Clinical Sample And Antimicrobial Susceptibility Testing

 Immunology (HIV testing, Rheumatoid factor Detection, Rapid plasma regain test for syphilis, Rapid test for plasmodium falciparum / p.vivax - Antigen, Hepatitis B surface Antigen by Immunochromatography, ELISA, Dot ELISA

 Six month Training as “Clinical Research Coordinators” under DR. Anish Maru at Department of Sr. Consultant-Medical Oncology & Clinical Trials Investigators Dharamshila Hospital & Research Centre New Delhi.

 Work involved hands on protocol preparation, Site management, Safety reporting, Informed consent form, Subject sample collection & chain of custody, Laboratory testing procedures, Data queries resolution, Data Collection & source document.

Date of Birth: 15th July 1989 (Neeraj Singh)