Rayudu padmaja

934-***-****

adppgb@r.postjobfree.com

OBJECTIVE

To work with the organization and be a part of its development activities, which provides continuous opportunities to learn, grow and excel in the field of pharmaceutical research & development . skills : pharmacovigilance, clinical research

EDUCATION QUALIFICATION:

· B. Pharmacy from Pydah college of pharmacy, kakinada ; Affliated To AU visakapatnam .

· Higher Secondary Education from Sri Chaitanya Junior College, vijayawada.

· SSC from maria Montessori high school, mummidivaram.

DOMAIN SKILLS

Clinical Research

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

· Clinical trial Monitoring (CRA) and Responsibilities of Monitor, CRA, CRC, Investigator, Sponsor.

· ICH-GCP -13 Core PRINCIPLES

· Difference between ICH-GCP and Indian GCP

· Informed consent Process, Reporting (AE, SAE)

· NEW DRUG & CLINICAL TRIAL RULE 2019 CDSCO

· Knowledge of GCP and ICH guidelines including basic understanding of regulatory requirements for clinical research and Pharmacovigilance.

Pharmacovigilance

· ADR, Serious Adverse Reaction, SUSAR, SAE, MedDRA, Risk Management, ADR Monitoring, Narrative Reports.

· Causality Assessment, Signal, Frequency of ADR, De-challenge, Re-challenge,CIOMS.

SKILLS:

· Office Tools : MS Word, Excel, Power Point

· Operating System : Windows-xp,windows7

· Dictionary : MedDRA & WHO Drug.

Trainings & Certifications:

· Completed Advanced Certified Course in Clinical Research from Gratisol Labs.

· Completed certification in Good clinical practice from NIDA Clinical trials network.

· Completed certification in Introduction to Clinical Research from The Global Health Network.

· Completed certification in ICH GCP E6 (R2) from The Global Health Network.

· Completed certification in Data Management for clinical research studies from The Global Health Network.

· Completed certification in The Study Protocol from The Global Health Network.

Personal details

Name : Rayudu padmaja

Father name : Rayudu Sundar ram

Gender : female

Date of birth : may 14, 2000

Marital status : unmarried

Language : telugu, English

Address : Door no; 16/ 48, mukteswaram road chippalapalem, mummidivaram east Godavari 533216 andhra pradesh

DECLARATION

I have by something declare that all the details written above are true to the best of my knowledge and belief

PLACE

DATE

(R padmaja)

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