RESUME

Mamidi. Prithvidhar Reddy Email: ady48x@r.postjobfree.com

Address: **** * ****** *******, **, 60645 Mobile No: +1-646-***-**** Seeking a position that offers professional growth where I can utilize my skills through hard work, dedication, and innovation and become well-known for my contribution to my field. ORGANISATION : Parexel

DESIGNATION : Drug Safety Associate

DURATION : 16 Dec 2019 to 24-Dec-2021

LOCATION : India

ORGANISATION : Bioclinica

DESIGNATION : Drug Safety Associate

DURATION : 28-Aug-2017 to 4-Jun-2019

LOCATION : India

1.9 years of experience in ARISg

2 years of experience in Oracle Argus Safety Database

Good Knowledge of computers and software such as MS Office, Excel, PowerPoint, WebEx and Outlook.

Can demonstrate good critical thinking and problem-solving skills.

Have 2 years of experience with electronic data capture systems like Rave, OCRDC

Programming skills with SQL, Python, and clinical SAS .

Have extensive knowledge and experience with electronic health record databases such as EHRgo.

ICSR Case processing

Triage

Quality control

I worked as Drug Safety Associate in Pharmacovigilance Domain. ROLES AND RESPONSIBILITIES AT PAREXEL

• Triage of incoming reports for completeness, legibility and validity

• Electronic documentation and quality control of drug safety information

• Data entry of case reports into safety database / tracking system

• Request follow-up and perform query management

• Coding of data in the safety database

• Writing case narratives

• Create and maintain project specific working files, case report files and project central f files

SKILLS (CORE COMPENTENCIES)

CAREER OBJECTIVE:

PROFESSIONAL EXPERIENCE

DOMAIN EXPERIENCE

ORGANISATIONAL EXPOSURE

• Assist with additional Drug Safety Specialist and/or Medical Operations Leader (MOL) activities as required

• Inform Line Manager (LM)/Team Manager, Medical Operations Leader (MOL) or Project Leader (PL) and Regional Head of PV Operations of potential change-in-scope of projects

• Support of Medical Directors/Safety Physicians, as needed, in medical monitoring activities

• Participate in client and investigator meetings as required

• Attend internal, drug safety and project specific training sessions

• Perform literature searches

• Preparation for, participation in, and follow up on audits and inspections

• Delegate work as appropriate to Drug Safety Assistants

• Assistance in the development of Expedited Reporting Procedures

• Assistance with registration with relevant authorities for electronic reporting on behalf of sponsor

• Assistance with setting up and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy)

• Assist with unblinding of SUSARs, as required

• Preparing study guidance document by referring to study protocol and other study- related documents.

ROLES AND RESPONSIBILITIES AT BIOCLINICA

Serious Adverse Event (SAE) and Non-Serious Adverse Event Report Case Processing.

Processing Suspected Unexpected Serious Adverse Reaction (SUSAR) cases in clinical studies, Spontaneous, Literature and PCFR (parent child fetus reporting) cases strictly compliant to 15 calendar days and 30 calendar day timelines.

Processing Business partner, Litigation (Legal) and device cases.

MedDRA coding and Narrative writing, processing for different cases like E2B and R3 cases.

Performing the tasks of maintaining the safety database and performing coding of diseases as well as adverse events according to the project-specific coding conventions.

Assuring medically cohesive narrative with completeness and accuracy.

Assessing causality and expectedness of adverse events as per documents like IB (investigational broacher) and RSI (reference safety information).

Adverse event (AE) coding by MedDRA browser and drug coding by CPD and WHO-DD browser, working on ARISG safety database, Coding events, indications and patient history based on MedDRA.

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

Adverse events and its reporting standards.

Expertise in duplicate search and case initiation, selection of adverse events, seriousness, expectedness or listedness of adverse events, causality, case Book-in, post market case processing

Educational Qualifications:

Masters in health informatics at Governors State University, University Park, Illinois, Chicago.

Pharm. D(Doctor of Pharmacy) from navodaya pharmacy college,raichur affiliated to Rajiv Gandhi University of Health Sciences, Karnataka, INDIA (pass out year 2017)

Higher Secondary Education from Sri Chaitanya Junior College Hyderabad, Telangana

(pass out year 2010)

SSC from Kendriya Vidyalaya, o.d.f Yeddumailaram, medak from C.B.S.E Board (pass out year 2008).

PUBLICATIONS:

Project entitled “A study on prescribing pattern of antibiotics for surgical prophylaxis in a tertiary care teaching hospital in north Karnataka” as an academic project which was published in World journal of pharmacy and pharmaceutical sciences (wjpps).

As part of Pharm D (Doctor of Pharmacy) curriculum did the 1 year internship in navodaya medical college hospital & research center in Raichur, Karnataka, India. During my internship, I worked in departments like general medicine, orthopedic, OBG, and pediatrics.

Name: Mamidi prithvidhar reddy

Date of Birth: 04-Mar-1993

Gender: Male

Marital Status: Single

Nationality: Indian

Languages Known: English, Hindi and Telugu.

PERSONAL PROFILE:

I hereby, declare that the above written particulars are true to the best of my knowledge. Place: Chicago (Mamidi prithvidhar reddy)

DECLARATION:

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