OBJECTIVE:

To secure a challenging position in the organization and to excel as a Successful Employee in the organization and to strive for the growth of it by becoming the part of the team with hard work and commitment.

EDUCATION QUALIFICATION:

Masters in Engineering Management (MSEM) (May 2017) from Trine University Angola, Indiana, USA.

Bachelor in Pharmacy (2011) from Rajiv Gandhi University of Health Sciences, Bangalore, India.

WORK EXPERIENCE

Worked in RA CHEM PHARMA LTD From Sep2011 to July2015, In Clinical Research And Biosciences Division as Officer, (QA/RA)Quality assurance/ Regulatory Operations Associate for Bio-analytical department.

Roles & Responsibilities:

Ensuring the compliance of Calibrations/Validations/Timely maintenance of Instrument/Equipment.

Inspection of the procedures by System Specific Audits and reporting of inadequacies.

Online monitoring, review of data, ensuring resolving of errors and inconsistencies in order to ensure quality of the study.

Ensure that the study is conducted in compliance with approved protocols, relevant SOPs and applicable regulatory requirements

Preparing deviation trend analysis and working with the Head QA/RA to resolve the inconsistencies.

Understanding of aspects like Total Quality Management and Quality Management System.

Verification of corrective and preventive action.

Good knowledge in GMP, GCP, GLP and GDP.

Format, assemble and prepare regulatory documents and forms for submissions and other regulatory correspondence.

Contributed in preparation, review and compilation of IND, NDA/ANDA, protocol

amendments, information amendments, safety reports, annual reports, DSUR and DMF.

Contributed in reviewing submissions including CMC modules, CTRs so they comply with standards and regulations.

Apply quality control processes and engage in lifecycle management of submissions to ensure document integrity.

Responsible for all operational tasks associated with or in support of authoring,

formatting PDF renditions, bookmarking, hyper-linking with the help of ISI toolbox to ensure eCTD submission readiness of documents.

Assist the team in managing electronic submissions and lifecycle operations when required.

Proactively visit the FDA website to stay on top of new guidelines, MAPP's and seminars.

Promote the best use of technologies for submissions, including: publishing

software, eCTD publishing tools, document management system, and ISI Toolbox.

PROFESSIONAL OVERVIEW

Pharmacovigilance Trainee:

Gratisol Labs, Hyderabad, INDIA

I have undergone rigorous training in Oracle Argus Safety Database 6.0, with Pharmacovigilance foundation.

Roles & Responsibilities:

Case assessment

Duplicate check and case initiation

MedDRA coding

WHO DD coding

SAE narrative writing.

Expectedness or Listedness of adverse event

DOMAIN SKILLS

Clinical Research & Pharmacovigilance Domain Awareness

Knowledge of drug development (Phase I -IV) of clinical trial.

Pharmacovigilance in India.

Adverse events and its reporting standards

Adverse events reporting forms.

Expedited case and its reporting time lines.

Hand on experience on Oracle Argus Safety 6.0 Database - Data Entry, Case Processing, MedDRA coding, SAE narrative writing.

Attended the GCP, GDP, andGLP training conducted by CLINapps at RA Chen Pharma Ltd

OBJECTIVE:

Contact this candidate