Harika Samuel Dubba, MD ***** Lister Terrace Ashburn, VA 20147 Phone: 703-***-**** Email: add5kl@r.postjobfree.com

CAREER OBJECTIVE:

● Physician with experience in drug safety and pharmacovigilance and also in Research field looking for a position in a dynamic biopharmaceutical organization where I can pursue a career, gain valuable experience and grow.

RESEARCH EXPERIENCE:

● Completed 228 hours of clinical research coordinator training from Clinical Research Fastrack in topics such as Research Concepts, ICH GCP guidelines, FDA Regulations, Informed Consent Process,

● Experience in Investigator Responsibilities, Protecting the Rights of the Patient, Adverse Events & Protocol

● experience in Deviations, Regulatory Affairs, Recruitment and Retention of Clinical Research Subjects, Quality

● Assurance & Inspections, Protocol & Clinical Trial Budgeting, Data Management Systems,

● experience in Documentation Practices, Clinical Trial Operations, Monitoring, Research Skills Training and Medical

●Sound knowledge in Medical Terminology & Common Medications in General Practice.

-I am extremely honored to be a part of Clinical Research. It gives me immense joy and satisfaction to partake in the process where a molecule could be transformed into a medical miracle that can save millions of lives. I believe that I can bring a unique perspective into the field of research with my diverse educational background (Asia and USA).

WORK EXPERIENCE: May 2018 - present: Clinical Medical Assistant Dulles Medical Group, Leesburg & Sterling, Virginia

● Assist and work with physician/physicians to provide excellent general patient care and medical coding

● Triage patients to identify different levels of need

● Perform basic clinical intake: update the Electronic Health Records (EHR) system and patient history, medications, etc.

● Obtain vital signs (height, weight, temperature, blood pressure, pulse and respiration rate) and a brief history from patients

● Perform phlebotomy for clinical laboratory tests ordered by the physician

● Schedule appointments; place reminder calls

● Handle prescription authorizations; and prescription refills

● Perform inventory / stock medical supplies

● Ensure the cleanliness and safety of patient care areas by appropriately maintaining examination rooms; and stock examination rooms.

● Provide compassionate, culturally sensitive and competent medical care to patients

● Offer friendly, courteous assistance to every patient to ensure patients have a positive, professional experience during their visits to the physician’s practice

Jan 2016 - Sep 2017: Clinical and Administrative Assistant Comprehensive Primary Care, Ashburn, Virginia

● Performed clinical and administrative medical assistant duties on this job

● Assisted and worked with physician/physicians to provide excellent general patient care and medical coding

● Triaged patients to identify different levels of need

4 Harika Samuel Dubba, MD /

● Performed basic clinical intake: updated the Electronic Health Records (EHR) system and patient history, medications, etc.

● Obtained vital signs (height, weight, temperature, blood pressure, pulse and respiration rate) and a brief history from patients

● Performed phlebotomy for clinical laboratory tests ordered by the physician

● Assisted at the front desk

● Assisted in administrative duties and backroom activities

● Scheduled appointments; placed reminder calls

● Handled prescription authorizations; and prescription refills

● Performed inventory / stocked medical supplies

● Ensured the cleanliness and safety of patient care areas by appropriately maintaining examination rooms; and stocked examination rooms.

● Provided compassionate, culturally sensitive and competent medical care to patients

● Offered friendly, courteous assistance to every patient and ensured patients had a positive, professional experience during their visits to the physician’s practice

DRUG SAFETY ASSOCIATE: (2015-2016)

Overall one year of experience in Drug Safety and Pharmacovigilance using Oracle Argus.

Experience in implementing Good Pharmacovigilance Practice (GVP), risk evaluation &

safety management and mitigation plans as per US FDA, ICH-CIOMS guidelines, clinical trial

guideline (GCP), SOPs and regulations.

Implementation of corrective action & preventive actions (CAPAs) for assigned product.

Experience using MedDRA & WHO-DRUG Dictionaries for coding adverse events.

Well versed in regulatory reporting & reporting timelines for submission of SAE & AE for FDA &

EMEA.

Expert to evaluate causality of signal detection & submit medical narrative writing for serious and

unexpected adverse event.

Expertise in Narrative writing.

Triaged incoming cases to determine seriousness for prioritization of daily work flow, Handled

responsibilities of reviewing and processing adverse events reported by investigators

Knowledge of medical journals/database – Like PubMed, MedWatch, ClinicalTrial.gov

Customer Service activities included speaking with complainant, coordinating follow-up actions,

and updating hard copy and database files

Process and report non-serious and serious adverse events in Argus Safety Database for post-

marketed products and investigational products being assessed in clinical studies in accordance

with FDA, EMA and ICH guidelines

Strong knowledge of AE/SAE reporting guidelines and procedures and medical terminology.

Ability to prioritize, plan and organize work assignments, and able to work under strict timelines.

Ability to work with competing priorities and demands.

Strong organizational and timeline management skills.

Effective verbal and written communication skills and able to meet strict project deadlines and

Oct 2010 - Feb 2012: Medical Officer (Internship) Mamata Hospital, Khammam, India

● Rotating Internship.

● 2 months each in: Community Medicine; Internal Medicine including psychiatry; Surgery including anesthesia; and Obstetrics & Gynecology including family welfare planning.

● 1 month each in: Pediatrics; and Orthopedics.

● 2 weeks each in: Ear Nose and Throat (ENT); Ophthalmology; Casualty; and Radiology.

EDUCATION:

Aug 2004 – Feb 2012: Bachelor of Medicine, Bachelor of Surgery (MBBS = MD Degree)

Osmania University, Hyderabad, India

● Graduated with distinction in Pharmacology

LICENSURE, TRAINING & CERTIFICATIONS: Jun 2016: Passed United States Medical Licensing Exam (USMLE) Step 2 Jan 2013: Passed United States Medical Licensing Exam (USMLE) Step 1 Educational Commission for Foreign Medical Graduates (ECFMG) Philadelphia, PA

Jan 2017: Cardiopulmonary Resuscitation (CPR) Certification Following Heartsaver® CPR AED Training Course

Aug 2015: Nationally Registered Certified Medical Assistant (NRCMA)

MedCA, New York, NY

Feb 2012 - present: Medical Registration Certificate

Andhra Pradesh Medical Council, Hyderabad, India

● License to practice medicine in India.

SPECIAL SKILLS:

● Computer skills – proficient user of Microsoft Word, Excel and PowerPoint; Internet; and Electronic Health Record (EHR) Systems - eClinicalWorks®; and Allscripts®

● Possess exceptional customer service skills

● Hard worker with excellent time management and organizational skills; and problem solving skills

● Ability to work independently and in a team environment

● Work very well in fast-paced and in high-stress environments

● Effective verbal and written communication skills.

ACTIVITIES AND INTERESTS

Volunteer Activities: Jan 2017 - present: Volunteer Sunday School Teacher Agape Church, South Riding, Virginia.

Interests

● Cooking; Reading; and Singing Gospel Songs.

Contact this candidate