Summary
Overview
Work History
Education
Skills
Experience Years
Experience Months
Daughter Name
Personal Information
Timeline
Generic
MARY D

MARY D

Pharmacovigilence Scientist
Bangalore,Karnataka

Summary

Results-driven pharmacovigilance professional with robust expertise in drug safety and regulatory compliance, currently serving as a Safety Scientist 1 (responsibilities include Quality review and case processing).

I possess extensive experience in processing Serious Adverse Events, Adverse events, engaging in quality reviews, and generating comprehensive reports for clinical trial cases, spanning Phases I to IV.

My proficiency includes mastery of various databases such as Aris G and Argus, alongside solid skills in MedDRA coding and clinical trial report writing.

Processing of spontaneous literature, E2B cases with a strong background in client interaction, data entry, and adherence to pharmacovigilance regulations, I continuously aim to apply my skills in dynamic environments.

Balancing my professional endeavors while effectively managing personal commitments, I am dedicated to contributing to the advancement of drug safety practices.

Determined and well-rounded individual with more than 7 plus years working as Scientist within pharmaceutical industry. Sharp and focused professional.

Developed skills in collaborative research environment, excelling in data analysis and critical thinking. Seeking to transition into new field, leveraging strengths in research methodologies and scientific communication. Committed to applying detail-oriented approach to solve complex problems and drive innovation.

Overview

10
10
years of professional experience
4035
4035
years of post-secondary education
5
5
Languages

Work History

Pharmacovigilance Safety Scientist

WCG clinical
10.2022 - Current
  • Conducted comprehensive processing and Quality review of Phase I to Phase IV clinical trial cases, ensuring adherence to regulatory standards.
  • Completed training courses and extracted essential reports including DSUR and PSUR, enhancing knowledge and compliance.
  • Processing of SUSAR, Death and Life-threatening cases in due timelines.
  • Generated AOSE reports for SUSAR cases, facilitating timely communication of safety data.
  • Executed thorough quality reviews and delivered final CIOMS reports to clients, ensuring high-quality deliverables.
  • Managed queries and maintained client-specific trackers, enhancing responsiveness and client satisfaction.
  • Interpreted medical reviewers' comments on causality and expectedness, contributing to informed decision-making and critical thinking in safety assessments.
  • Attending team meetings, providing SUAR packages to the clients.
  • Simultaneously managed several complex projects, meeting all pertinent milestones.
  • Implemented quality control measures to ensure the accuracy and reliability of the projects.
  • Performed all activities for the audit preperation
  • Trained new employees on areas of technical expertise and compliance issues relevant to case processing.
  • Performed SAE reconciliation for various clients ensuring quality.

Drug Safety Associate 1

Qinecsa
09.2020 - 10.2022
  • Utilized Aris G database, LSSMV, and LSIT tools to enhance data management and processing efficiency.
  • Processed various types of cases, including clinical trial, Spontaneous, Legal, R3, E2B, Health Authority, Literature, and Pregnancy cases.
  • Developed medical cohesive narratives, ensuring accuracy and completeness of all documentation.
  • Executed intake, triage, data entry, and comprehensive quality control activities to maintain high data integrity.
  • Facilitated client interactions and managed queries to enhance communication and support.
  • Conducted quality reviews to ensure adherence to pharmacovigilance regulations and standards.
  • Improved patient safety by accurately reviewing and processing adverse event reports.
  • Assisted in the development and implementation of training materials, contributing to the ongoing education of fellow Drug Safety Associates.
  • Interacted with manager to discuss ongoing projects and maintain workflow and timelines.
  • Proactively identified areas for process improvement within the drug safety department, leading to increased productivity.

Career Break (Post Maternity)

Post Maternity Break
07.2018 - 09.2020
  • Looked after the household responsibilities while ensuring personal development.
  • Attended various master workshops online to enhance the skills that corporate world needed
  • Efficiently spent time with my kid and gave her quality time as a mother.

Safety Associate 2

IQVIA
10.2016 - 07.2018
  • Utilized Argus, Apex, Medidata Rave, and Inform databases to enhance data management and reporting efficiency.
  • Processed Serious Adverse Event (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR) cases, ensuring compliance with 2-Day and 5-Day regulatory timelines.
  • Executed MedDRA coding and developed comprehensive narratives for clinical, spontaneous, legal, and pregnancy-related cases.
  • Evaluated causality and expectedness of adverse events, aligning assessments with key regulatory documents including IB, EUSPC, CDS, and USPI.
  • Drove client communication, effectively resolving queries while optimizing team allocations to ensure seamless project execution.
  • Provided support during audits by gathering relevant documentation, demonstrating the organization''s commitment to safety standards.
  • Developed effective working relationships with employees at all levels within the organization, fostering a culture of safety consciousness across teams.

Process Coach

Omega Health Care
01.2015 - 06.2016
  • Led a team of 20 members, enhancing quality and production control through effective leadership.
  • Managed client interactions, resolving queries proactively to ensure timely delivery of services.
  • Provided comprehensive floor support, maintaining accurate process documentation to uphold operational standards.
  • Developed and delivered training materials for team members, leveraging tools such as Excel, Word, and PowerPoint to enhance skillsets.
  • Worked on US government claims like medicare Medicaid, and other third-party insurances and ensured 100% accuracy.
  • Optimized production scheduling by analyzing capacity constraints and aligning resources accordingly.
  • Standardized work instructions for greater consistency across all shifts and departments.
  • Facilitated Kaizen events to drive continuous improvement within the organization.
  • Mentored junior team members in process coaching techniques for better workforce performance.
  • Developed process improvement initiatives for increased productivity and cost reduction.

Education

Master of Science - PHARMACEUTICS

Jawaharlal Nehru Technological University (JNTU)
Anantapur, India
04.2001 - 01.2014

Bachelor of Science - Pharmacy

Jawaharlal Nehru Technological University (JNTU)
Anantapur, India
04.2001 - 01.2011

12th - English

Sai Natha Juniour College
Palamaner
03-2007

10th - English

St. Mary's School
Palamaner
03-2005

Skills

  • MS Office

  • Project management

  • Data Entry

  • MS Excel

  • Safety processes and procedures

  • Critical thinking

  • Pharmacovigilance

  • Drug Safety

  • Problem-solving abilities

  • Time management

  • Interpersonal skills

  • Adaptability

  • SUSAR case processing

  • Audit preperations

  • Share point

  • Narrative writing

  • Quality review

  • Proficient in MS office tools

  • Basics of power BI

  • Strong work ethic

Experience Years

7

Experience Months

0

Daughter Name

D Ivana Wilson

Personal Information

  • Father's Name: D Javed
  • Mother's Name: Hena Leelavathy
  • Husband's Name: D Wilson Emmanuel

Timeline

Pharmacovigilance Safety Scientist

WCG clinical
10.2022 - Current

Drug Safety Associate 1

Qinecsa
09.2020 - 10.2022

Career Break (Post Maternity)

Post Maternity Break
07.2018 - 09.2020

Safety Associate 2

IQVIA
10.2016 - 07.2018

Process Coach

Omega Health Care
01.2015 - 06.2016

Master of Science - PHARMACEUTICS

Jawaharlal Nehru Technological University (JNTU)
04.2001 - 01.2014

Bachelor of Science - Pharmacy

Jawaharlal Nehru Technological University (JNTU)
04.2001 - 01.2011

12th - English

Sai Natha Juniour College

10th - English

St. Mary's School
MARY DPharmacovigilence Scientist