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Pharmacovigilance associate

Location:
Weston, FL
Posted:
July 29, 2022

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Resume:

Dr. Pavithra Ashok Thungathurthi

Email adrxgf@r.postjobfree.com Phone - 302-***-****

A well rounded medical professional with 10+ yrs experience in Clinical Research (3+ Yrs), Pharmacovigilance (1+ Yrs) and Clinical experience(8+Yrs). WORK EXPERIENCE:

Clynico ConsulLng LLC, Pharmacovigilance Consultant. July 2021 - present

IdenFficaFon, creaFon, and review of SOPs for clinical trial sites and pharmacovigilance acFviFes.

CoordinaFon in ensuring the implementaFon and pracFce of all requirements of the QMS systems managing PV/Clinical trial acFviFes.

Assisted in data collecFon, sorFng, and documentaFon of clinical informaFon within the constraints of the project.

Review of risk minimizaFon measures materials for the EU market

DraUed iniFal study start-up documents including case-report forms, protocols, informed- consent forms, clinical InvesFgaFon plans, data-safety-monitoring board charters, and clinical- trial agreements.

Coordinate and facilitate signal management and the conFnuous risk-benefit of marketed products perform full case processing acFviFes including the submission of individual case safety reports to the relevant competent authoriFes

Assist in wriFng and reviewing aggregate reports (PSUR/DSUR/REMS/RMPS), PSMF, and signal detecFon reports.

Deputy training coordinator in charge of assessing and maintaining compliance with all stakeholder's training under the supervision of the global training coordinator

Review of clinical trial protocols for EU markets.

Remote clinical trial site monitoring and management to ensure data integrity and milestones are met in line with the sponsor and protocol

Review and assess retrospecFve Cohort studies and Randomized controlled trials many of these studies

Looked at the efficacy of the drug intervenFons as well as surgical/procedural intervenFons, to ensure regulatory and ethical compliance.

Boston Medical Center, Clinical Trainee (IGTP) – Dermatology July2020-Jun2021

(Boston, MA)

Worked under mulFple specialists like Cutaneous Oncology, Rheumatology, Gyneco-Dermatology, Wound Clinic, Pediatric- Dermatology, and General Dermatology. My Job DuFes include (but are not limited to)

Examined paFents and ordered diagnosFc tesFng.

Performed laboratory tests on skin.

Examined and treated scars abrasions and severe acne.

Specialized in both adult and children's skin disease treatment

A_ended Grand Rounds and CME sessions that exposed me to latest developments in the field of Dermatology.

Presented mulFple CPC (Clinical Pathological CorrelaFons ) on exisFng and upcoming treatments for different skin condiFons.

Aster Prime Hospitals Physician May2015-

July2017

(Hyderabad, India)

Worked as Clinical Research Coordinator in collecFng paFents’ data, enrolling them in research studies and following up with the paFents.

Worked as a physician in the Ophthalmology and Dermatology department.

Assisted the pathologist in slide preparaFons

Maharaja InsLtute of Medical Sciences, Resident Ophthalmology May2010- April 2015

(Vijayanagaram, India)

Joined as a resident in Ophthalmology where I examined paFents with different eye condiFons and also ordered diagnosFc tesFng.

Performed mulFple Cataract surgeries.

Research on Keratometry studies of paFents who underwent cataract surgeries. Pavithra Nursing Home, Physician Jan 2007- Apr2010

(Hyderabad, India)

Managed the daily operaFons of the hospital.

Worked as physician in the clinical medicine (Internal Medicine) and Dermatology departments. EducaLon

Boston Medical Center July 2020- June 2021

Boston MA

InternaFonal Graduate Training Program- Dermatology.

Maharajah’s InsLtute of Medical Sciences, May 2010-Apr 2015 Nellimarla, Vizianagaram Dist, Andhra Pradesh.

Post-GraduaFon in Ophthalmology. (M.S)

Dr B.R Ambedkar Medical college, Sept 2000-Nov 2006 Bangalore, Karnataka, India

House Surgeon (Internship) Doctor of Medicine

Bachelor of Medicine and Bachelor of Surgery

CERTIFICATIONS AND WORKSHOPS

CiL Program July 2020 – Present

Offers a collecFon of Clinical research courses for research professionals Zonal CME May 2012

Dr. NTR University of Health Sciences, Vijayawada, AP, India. Zonal CME in Ophthalmology, Apr 2012

Sarojini Devi Eye Hospital, Hyderabad

Post-GraduaLon Training Program on HIV/AIDS Aug 2012 MIMS- Nellimarla

CME on Cornea and Anterior Segment PracLcal Lps. Apr 2012

(Hyderabad Ophthalmologists AssociaFon)

Basic course in ophthalmic DiagnosLcs Mar 1st-Mar 31st 2011 L V Prasad Eye InsFtute, Hyderabad.

Eye 2 Future Oct 1-3rd 2010

(Andhra Pradesh Ophthalmological Society)

Specialty PosLng in Ophthalmology Dec 2011-Feb 2012 Sarojini Devi Eye Hospital, Hyderabad

Basic Surgical Skills & Wound management Dec 2006

(Apollo Hospitals, Hyderabad).

Professional SocieLes

Indian Medical Register 2007- Present.

Andhra Pradesh Medical council

RegistraFon number: 58794

VOLUNTEER SERVICES

Blood DonaLon Camp May 2012.

(Organized by Pavithra Nursing Home, Hyderabad, India) NaLonal Service Scheme – University Level Jan – Feb 2006 Student Volunteers learn to provide service to society without Bias, enhance the standard of living of the needy,

Leadership Experiences

AIDS Awareness Program Oct 2013

Sponsored by MIMS, Nellimarla, India.

Informing and educaFng about the disease sequelae of AIDS, Spreading Awareness of PrevenFon by promoFng safe sex pracFces, and the importance of Compliance to HAART therapy. Vision 2020 Aug 2012

(Sponsored by Government of India )

Pulse Polio ImmunizaLon Jan 2006

Sponsored by DR. B. R. Ambedkar Medical college, Bangalore, India. EducaFng Parents regarding importance of Polio Vaccines, helping them with Registering their children for immunizaFons.

Language Skills

English – Professional/Expert

Hindi – Professional/Expert

Telugu – Professional/Expert

Kannada – Professional/Intermediate



Contact this candidate