Penugonda Hemasoundarya

Mobile: + ** - 768*******

Email:ad0nuw@r.postjobfree.com

Job objective:

To achieve a challenging position in Pharmaceutical Industry and be a part of a team that dynamically works for the growth of the organization.

Profile Summary:

More than 2 years of experience in Clinical Research, Scientific writing and Research & Development in Pharmaceutical Sector.

Strong Knowledge in ICH-GCP and clinical trial guidelines.

Knowledge in clinical trial databases.

Knowledge in SOPs, Clinical Protocols for operation all implementation of Good Clinical Practice (GCP) and applicable regulatory authorities.

To obtain the regulatory authorities approval (such as CDSCO, USFDA) for conducting the trials.

KEY SKILLS:

Scientific writing, Clinical trials, GCP (Good clinical practice), Regulatory Writing, Pharmacovigilance Reporting,

PROFESSIONAL EXPERIENCE

Bioclinica 1.8 Months (Jan 2021 – Aug 2022)

Profile

Roles and Responsibilities

Drug Safety Associate

•Confirms case validity

•Responsible for data entry of Individual case safety reports into the safety database.

•Review and evaluate AE case information to determine required action based on and following internal policies and procedures.

•Process all incoming cases in order to meet timelines.

•Full data entry including medical coding and safety narrative as required.

•Enter and code, as applicable, case data, including but not limited to event, seriousness, reported causality (when appropriate), medical history, and laboratory data as provided by the reporter.

•Code products specified as suspect or concomitant by the reporter

•Provide the narrative, as required

•Review Adverse Event (AE) report data for completeness and verify certain fields to determine as critical (including but not limited to reportability) as well as conformity to E2B standards.

•Initiate follow-up activities to obtain additional information and clarification, as appropriate.

•Forward cases for case review or invalid workflow in the global safety database.

•Peer review the cases and evaluate for accuracy, consistency, and completeness in the safety database against the source document. This includes, but is not limited to, checking consistency of narrative and other data fields, ensuring main reason for any delay is entered in the routing comment as appropriate

•Confirms event term selection and coding

•Confirms/assesses event seriousness

•Performs listedness assessment

•Initiate SUSAR process via notification to Pfizer and routing of the case back to Pfizer for processing

•Determine whether additional queries through the DSU are needed at this stage and document them in the global safety database with a brief description of the information needed

•Identify spontaneous cases that are a result of stimulated reporting by adding the appropriate case classification

•Correct the data entry errors, if any, prior to routing the case in the global safety database

•Track and document all observations and recommendations on the defect tracker

•Ensure adherence to the Quality Assurance Program and conduct the Quality Control (QC) review as outlined

To obtain the regulatory authorities approval (such as CDSCO, USFDA) for conducting the trials.

SG Analytics 6 Months (Jul 2020 to Dec 2020)

Profile

Roles and Responsibilities

Analyst

Client based work with US Team (Inform Pharma Intelligence) Working on regulatory documents, Pipeline data, company press release and Medical devices particularly with (510K), catalyst, clinical evaluation work on medical devices and event data and currently working on Pharma projects and biomed tracker, Earning data of pharmaceutical companies . Finding approved labels for orphan designated drugs.

Global Data Research Center 2.2 months (Apr 2018 to Jun2020)

Profile

Roles and Responsibilities

Associate Analyst

•Secondary search for the information of clinical trials in pubmed, OVID, EADGAR, company presentation, sec filings, medline, chroncale, company reports.

•Clinical trial database (Integrated Pipeline and Marketed Products Database).

•Primary research and market survey of global medical products.

To obtain the regulatory authorities approval (such as CDSCO, USFDA) for conducting the trials.

Developing and writing Clinical Study Reports, development of Clinical Trial protocols, ICF’s, CRF’s

•Maintaining records of clinical investigators, CROs and IRB involved in the conduct of IND studies with human investigational drugs and therapeutic biologics.

•Integration of drugs based upon countries location and companies, ensuring high quality clinical trial data review/insights and analysis as directed by the integrated.

•Presently working on the likelihood, biomarkers, feasibility planner, and catalyst.

•Scientific content developed by using cactus medical affairs of client

•Evaluatimg PI oversight subject safety and study processes in order to assess sites ability to conduct study as ascernatied from information noted monitoring visit reports and asscodiated EDS.

•Review of clinical trial data for its accuracy, completeness and regulatory compliance.

•Performing Monitoring tasks (Pre-study, during study and Monitoring Close-out).

•Review of clinical trial data for its accuracy, completeness and regulatory compliance.

•Performing Monitoring tasks (Pre-study, during study and Monitoring Close-out).

•Taking care of the accuracy of reviewed clinical raw data, facilitating inputs for the preparation of clinical reports and writing SOPs as per the requirements.

•Performs quality control (QC) checking / proof reading of all the deliverables to meet customer expectations.

Academic Profile

PG

M.Pharmacy (Pharmacology)

2018

Chalapathi institute of Pharmaceutical sciences

Graduation

B.Pharmacy

2016

Adarsa College of Pharmacy

Schooling

2010

St.Thomas High School

Other Achivements

Certifications

Awarded as best employee of the month in GD

Awarded as best journal writer of quarter in SG

Awarded as best employee of the month in Bioclinica

Participated in SEMINAR&PAPER PRESENTATION in JNTU Kakinada.

Participated in SEMINAR&PAPER PRESENTATION in Koringa College of pharmacy.

Participated in SEMINAR&PAPER PRESENTATION in Vikas College of pharmacy.

Participated presented a paper in 67th IPC held at MYSURU.

Certified as a volunteer in the international conference of pharmacoeconomics and pharmacoepidemiology held in Chalapathi institute of pharmaceutical sciences.

Participated in Symposium on current scenario in clinical research held at CLPT.

Participated certificate for elocution in the state level elocution and extempore contest -2016 held at Chalapathi institute of pharmaceutical sciences.

Participated in basic GCP curriculum training held at vimta labs, Hyderabad.

Participated in national conference of HEALTH ECONOMICS AND OUTCOME RESEARCH conducted by ISPOR held at Chalapathi institute of pharmaceutical sciences.

Participated in national seminar on RECENT DEVELOPMENTS IN INVIVO EXPERIMENTATION- APRACTICAL APPROACH conducted by AICTE held at Gokaraju Rangaraju College of pharmacy, Hyderabad.

Completed the course of post-graduation in pharmacovigilance.

Completed the course of post-graduation in pharmacoeconomics.

Completed 3 months training in post-graduate diploma in pharmacovigilance certificate programmed held at Chalapathi institute of pharmaceutical sciences.

Technical Skills:

Well versed with MS Office Suite (Word, Excel & PowerPoint). Basic knowledge on cellular and molecular biology techniques like PCR, nucleic acid extraction, SDS-PAGE, western blotting technique.

Publications

Published a review article entitled: A short review on liver cirrhosis in an UGC approved journal i.e., international journal of pharmaceutical and clinical research.

Published a review article entitled: An over view of renal failure in an UGC approved journal i.e., world journal of pharmaceutical research (as co-author).

Published a review article entitled: Transgenesis a new tool in genetic commerce – A review in a science direct i.e., international journal of pharmaceutical research and novel sciences.

Personal Details

Name

Penugonda Hema Soundarya

Fathers Name

Penugonda Surya Narayana

DOB

23Nov1994

Residential Address

Nuzvid, Andhra Pradesh

Languages Known

English, Telugu, Hindi

Declaration:

I hereby declare that the above-mentioned information is correct up to my knowledge and I bear the responsibility for the correctness of the above mentioned particulars.

Signature

P. Hemasoundarya

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