Summary
Overview
Work History
Education
Skills
References
Languages
Languages
Timeline
Generic

R Andretta

Global Patient Safety
NY

Summary

Sound familiarity with medical terminology, FDA, ICH, and GCP regulations. Familiar with quality improvement initiatives for PiPs, QiPs, and HEDIS. Maintain a broad scope of knowledge to identify and pursue possible solutions to problems. Comfortable speaking with RNs, MDs, study coordinators, and patients. Outstanding ability to analyze, gather, write, evaluate, and produce detailed reports on a variety of projects. A team-oriented professional who works well under pressure, is goal-oriented, and has a commitment to exacting research and patient care. Extremely ambitious, with excellent written, verbal, and interpersonal communication skills. Ability to work independently. Organized and detail-oriented. Management skills to ensure quality assurance. Auditing to ensure compliance with NYS insurance reimbursement guidelines. Forward-thinking Operations Specialist bringing many years of expertise in industry sector businesses. A critical thinker cultivates rapport with individuals to optimize project goals and output, resolve complex problems, and deliver innovative improvement strategies. Analytical professional with technical knowledge and critical thinking skills to thrive in data-driven environments. Tackles challenges with positivity and drive to overcome. Works great alone or with others and consistently exceeds expectations.

Overview

20
20
years of professional experience

Work History

PV Operations Specialist

Amneal Pharmaceuticals
New York
05.2021 - Current
  • Company Overview: Global Patient Safety
  • Review, rank, verify and process case-related information according to case criteria, event terms, validity, seriousness, special scenarios, timelines, accuracy, and consistency
  • Escalate cases, where appropriate based on above assessments and document accordingly
  • Determine and perform appropriate follow-up activities
  • Collaborate with local key partners regarding safety data collection and data reconciliation
  • Client interaction includes addressing client questions and notifications
  • Expertise in handling AEs, AESIs and SAEs, writing case narratives for various cases and assisted with SAE reconciliation and QA of MedWatch reports
  • Excellent understanding of clinical trials process both for clinical trial drugs and post marketed drugs in various therapeutic areas
  • Develop and maintain expertise for corporate and global regulations, guidelines, Standard Operating Procedures, data entry conventions and search functions in the safety database
  • Expert in workflow of PV department for both post Marketing and clinical studies
  • Determine reportability of scheduled reports, ensuring adherence to regulatory requirements and Amneal’s policies
  • Participate in internal and external safety activities
  • Providing medical information and product inquiries
  • Anticipate and provide responses for labelling updates
  • Addressing medical information and remaining up to date in processes and procedures
  • Expertise in using safety databases such as ARGUS and ARISg and tracking databases like SharePoint
  • Monitor all the expedited SAE reports (SUSARs) are submitted to relevant Health Authorities
  • Prepare and write PV sections of aggregate safety documents such as DSUR (development safety update report) and PBRER (periodic benefit-risk evaluation report)
  • Global Patient Safety

Volunteer in Patient care

Elmhurst Hospital
New York
01.2012 - Current
  • Assisted in patient care
  • Assisted social workers
  • Communicate with patient’s family
  • Documentation

Government Health Care Center
Dehradun
07.2008 - Current
  • Patient care which included diagnosis and treatment.

Clinic Administrator

Merrick
01.2011 - 04.2021
  • Statistical analysis of monthly benefits reports
  • Monitor overall patient care
  • Provide follow-up to ensure quality assurance
  • Review clinic services to maximize daily productivity
  • Created interdisciplinary review committee to minimize mismanagement
  • Provide healthcare information and wellness to patients
  • Mediate between the insurance companies and practitioner to maximize profit

Emergency Physician

Yerevan State Medical University
Yerevan
01.2006 - 01.2008
  • Identified potential medical legal issues by monitoring documentation accuracy and completeness.
  • Assisted attending physicians in performing procedures such as lumbar punctures, intubations, thoracentesis.
  • Discussed patient treatment plans with physicians and medical professionals.
  • Ordered and executed diagnostic tests and analyzed diagnostic images to investigate patient conditions.

Emergency Attendant’s Assistant

Yerevan State Medical University
Yerevan
01.2005 - 01.2006
  • Entered data into databases accurately and efficiently.
  • Assisted attending physicians.

Education

MBA - Healthcare Administration

University of Northern Virginia
Annandale, VA
01.2012

Medical Doctorate - Physician, MD

Yerevan State Medical University
Armenia
06.2008

Senior Secondary Diploma -

Moravian School Institute
Dehradun, India
03.2001

High School Diploma -

Moravian School Institute
Dehradun, India
03.1999

Skills

  • Microsoft Word
  • Case processing
  • Data reconciliation
  • Safety reporting
  • Regulatory compliance
  • Aggregate safety documents
  • Medical writing
  • Quality assurance
  • Statistical analysis
  • Excel
  • PowerPoint
  • Database management
  • Client communication

References

Available Upon Request

Languages

  • English
  • Hindi
  • Armenian

Languages

English
Professional
Hindi
Professional
Punjabi
Professional
Armenian
Limited

Timeline

PV Operations Specialist

Amneal Pharmaceuticals
05.2021 - Current

Volunteer in Patient care

Elmhurst Hospital
01.2012 - Current

Clinic Administrator

01.2011 - 04.2021

Government Health Care Center
07.2008 - Current

Emergency Physician

Yerevan State Medical University
01.2006 - 01.2008

Emergency Attendant’s Assistant

Yerevan State Medical University
01.2005 - 01.2006

MBA - Healthcare Administration

University of Northern Virginia

Medical Doctorate - Physician, MD

Yerevan State Medical University

Senior Secondary Diploma -

Moravian School Institute

High School Diploma -

Moravian School Institute
R Andretta Global Patient Safety