CURRICULUM VITTAE

P.SANTHOSH KUMAR

WIDIA COLONY, MIYAPUR,

Hyderabad.

998-***-****

EMail:acs27u@r.postjobfree.com

OBJECTIVE

To work for an exemplary organization where I can work honestly towards accomplishing the organizational goals and objectives by rendering my skills and talents for the growth of organization, and in the process gaining by learning something new from my experience in the Organization and also to enhance my working and communication skills with the help of an emerging company.

CAPABILITIES

Strength lies in Determination, Commitment, Sincerity, Honesty, Integrity and Hard Working.

Team lead.

Handling the Pressure atmosphere.

EXPERIENCE

Presently working as Research associate - lI in RA (Regulatory submissions) of Axis Clinicals ltd, from Oct 2013 to till date.

Worked as Research associate -II in QA of Axis Clinicals ltd, from Oct 2010 to Sep 2013.

Worked as Research associate l in QA of Axis Clinicals ltd, from Jan 2010 to Sep 2010.

Worked as Research associate in clinical-QAU of Trident life sciences Ltd from Oct 2009 to Dec 2009.

JOB DESCRIPTION

Review of Integrated summary reports, Statistical & Bio analytical summary, Randomization reports etc.

e-CTD (M2 & M5) submissions for differents regulatories, Preparation of Regulatory dossiers etc.

Handling of Regulatory defficiencies & queries and updating of Regulatory changes etc.

Site Audits, compilation of Regulatory dossiers, Review of IEC dossiers etc

To determine whether all trial related activities were conducted, data recorded, analyzed and reported accurately & in compliance to protocol, SOPs, GCP and applicable regulatory requirements.

Internal audits of clinical research procedures, systems and personnel records of MNI.

Clinical site audits to evaluate site activity in compliance to protocol, SOPs, ICH-GCP & applicable regulatory guidelines.

Ensures that all employees are well trained for current regulatory guidelines & MNI SOPs.

Facilitating external audits/inspections conducted by sponsors, clients.

Assess internal trial master files and site-specific files in compliance to protocol, SOPs, ICH-GCP & applicable regulatory guidelines.

Perform audits at various stages of project conduct and resolutions of Corrective Actions and Preventive Actions (CAPA) items and deviations as assigned.

Maintain company auditing SOPs and make the necessary updates.

To maintain confidentiality of clients/project and related information as applicable.

Maintain records of audits Trails, audit reports and audit certificates.

Provides GCP guidance to internal departments for all phases of clinical drug development.

Coordinating the revision of SOPs, ensuring training, tracking of distribution and archival of SOPs.

Providing leadership as an author or reviewer in the development of QA controlled documents (e.g., SOPs, plans, guidelines and working practice document) as per the SOPs, or as determined in conjunction with management.

Contributing to the conduct of computerized system validation activities.

Developing and implementing a Quality Assurance Audit Plans i.e. assessment plan, site audit plan & vendor audit plan.

Generation, distribution, retrieval, archival of SOPs and maintenance of related records/ log books/ master list of SOPs.

Issue of controlled forms and log books for use.

Training of new employees by coordinating with different departments and maintenance of personnel files of all the employees.

Conducting Facility and System audits.

Carrying out periodic Inspection and Audit as per SOPs.

Site monitoring.

Review of Study protocols, Informed consent forms (ICF’S), Clinical Raw Data, Case Report Forms (CRF’s) and Clinical Reports in Compliance to SOPs.

Medical writing- review of Protocols and ICF’S.

Review of Biostatistics and Summary Reports.

Review of Soft ware validations and IQ/OQ/PQ of all the equipments and instruments.

Compilation of documents as per the regulatory requirement to support regulatory submission.

Archiving the study reports and related documents.

SKILLS

CLINICAL TRIALS AND CLINICAL DATA MANAGEMENT:-

I Have been extensively involved in double blind randomized parallel clinical trial projects that also comprises of clinical data management environment to manage the clinical data as per requirement defined in protocol in accordance with regulatory affairs responsibilities include handling source documents, informed consent forms CRFs by maintaining the ethical guide lines, also I have been involved in CRF designing, data validation, query management, safety data management to produce the desired AE/ SAE reports and managing clinical data infermitantly as per 21 CFR USFDA guide lines

PHARMACOVIGILENCE:-

Sound knowledge, AE reporting, monitoring and review of AE/SAE/etc.

ICH GCP, E-CTD, M-5.

Audit’s Faced/Certifications/achievements

Audit’s faced- US-FDA, UK-MHRA, CANADA, TURKEY, BRAZIL – ANVISA & DCGI.

Handled approximately 100 projects/Studies of different regions (USA, GERMANY, CANADA, EUROPE, AUSTRALIA, BRAZIL etc).

Certified by CDSCO for Workshop on 'Ethical issues in CLINICAL TRAILS'.

Workshop on “Basics of Good Clinical Practices”.

Got prizes as merit in poster presentations & sports.

Participated in national level seminars and poster presentations.

EDUCATIONAL BACKGROUND

Qualification

Institute

University / Board

Year of Passing

Division

B.Pharmacy

Balaji institute of pharmaceutical sciences, warangal.

(2006-2009)

KAKATIYA UNIVERSITY

2009

First

D.Pharmacy

Sri venkateswara college of pharmacy,vijayawada. (2004 – 2006)

ANDHRA UNIVERSITY

2006

First

Intermediate

Vikram junior college, Guntur. (2002 – 2004)

BOARD OF INTERMEDIATE

2004

First

S.S.C.

Sri viswasanthi high school, vuyyuru.

BOARD OF SECONDARY

2002

First

TECHNICAL SKILLS

PLATFORMS- Windows 98, windows XP, Acrobat Pro, TRS Tool box etc

LANGUAGE- C

DATA BASE- MS office. Open clinical

PERSONAL DETAILS

Name : P.SANTHOSH KUMAR

Fathers Name : P.SRINIVAS

Marital Status : Single

Date of Birth : 14th April, 1986.

Nationality : Indian

Religion : Hindu

Languages : English, Hindi, Telugu.

Permanent Address S/o P.SRINIVAS,

H.No:- 18-5-187/1,

KALYAN NAGAR,

GODAVARI KHANI.505209

Phone : 998-***-****

declaration

I assure that the above mentioned details are true to the best of my knowledge and belief and in view of the above concerned, hope u would give me an opportunity to work in your organization to prove my skills in regard for uplifting the organization status.

Date:

Place: Hyderabad.

(P.SANTHOSH KUMAR)

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