Summary
Overview
Work History
Education
Skills
Websites
Certification
Hobbies and Interests
Achievements
Languages
References
Timeline
Generic

Amrita Das

Vizag

Summary

Accomplished Aggregate Safety Scientist at Accenture with expertise in regulatory compliance and aggregate safety reporting. Proven ability to enhance data analysis and client collaboration, ensuring high-quality documentation and adherence to deadlines. Recognized for effective communication and attention to detail, contributing to successful pharmacovigilance outcomes.

Overview

12
12
years of professional experience
1
1
Certification

Work History

Aggregate Safety Scientist

Accenture
Bengaluru
11.2023 - Current
  • Preparation of Development Safety Update Reports adhering to regulatory guidelines and client specifications.
  • Organization of kick-off meetings and regular teleconferences to coordinate project timelines and objectives for report preparation.
  • Collaboration with clients to ensure precise collection and interpretation of data for inclusion in aggregate safety reports.
  • Contribution to strategic planning aimed at maintaining compliance with safety reporting regulations.
  • Coordination with stakeholders through continuous communication to ensure alignment on deliverables, and adherence to deadlines.
  • Review and analysis of aggregated safety data to identify trends or signals pertinent to pharmacovigilance activities.

Medical Safety Writer

Qinecsa Solutions
Mysuru
03.2020 - 09.2023
  • Drafting and managing periodic safety update reports and periodic adverse drug experience reports, with a focus on accuracy and compliance with regulatory standards.
  • Providing training on PBRER and DSUR processes to enhance understanding and expertise in regulatory document preparation.
  • Conducting quality reviews of regulatory documents prior to client submission, ensuring alignment with internal standards, and regulatory requirements.
  • Delivering feedback-driven training sessions based on internal and external quality control reviews to reduce errors and improve document quality.
  • Performing detailed analytical assessments of data for inclusion in regulatory submissions, supporting evidence-based decision-making processes.
  • Ensuring adherence to tight deadlines while maintaining high-quality documentation standards is vital for client satisfaction and successful regulatory approvals.

Data Analyst

Cognizant
Bengaluru
07.2018 - 02.2020
  • Conducted quality checks of Individual Case Safety Reports post-data entry to ensure accuracy and compliance within the safety database.
  • Reviewed medical coding and safety narratives for a thorough evaluation of adverse event case information.
  • Ensured adherence to established guidelines and regulatory timelines in processing safety data for submissions.
  • Collaborated with cross-functional teams to uphold quality standards in pharmacovigilance operations.
  • Monitored data integrity throughout reporting processes, maintaining high standards for reliability and data management.
  • Supported continuous improvement efforts by identifying gaps and ensuring compliance with evolving regulatory requirements.

Scientific & Medical Writer - Grade 1

Crest Premdia Solutions (a part of Springer Nature)
Pune
07.2016 - 06.2018
  • Conducted literature safety reports to support pharmaceutical and medical review processes.
  • Performed comprehensive literature searches to extract valid case reports based on specific criteria, including author attribution.
  • Identified adverse drug reactions effectively from abstracts and full-text articles for accurate reporting.
  • Entered data with precision into the safety database, ensuring compliance with regulatory standards.
  • Composed detailed narrative documents, emphasizing thoroughness and clarity in alignment with editorial guidelines.
  • Executed rigorous editorial reviews to maintain the accuracy and quality of written scientific content.

Drug Safety Operational Specialist

Quintiles India Private Ltd.
Bengaluru
11.2015 - 04.2016
  • Participated in internal meetings concerning pharmacovigilance topics and presented updates on safety issues related to products under surveillance.
  • Assessed causality of reported events according to the World Health Organization criteria.
  • Evaluated individual cases for appropriate follow-up action and serious adverse event reporting to regulatory authorities worldwide.
  • Tracked quality metrics associated with pharmacovigilance activities.
  • Interfaced with health care professionals, patients and internal departments regarding questions about adverse events.
  • Reviewed scientific publications related to pharmacovigilance topics and provided summaries when necessary.

Senior Drug Safety Associate

Synowledge LLC
Mysuru
08.2013 - 10.2015
  • Entry and management of Individual Case Safety Reports in the safety database to ensure accurate and efficient reporting.
  • Creation of medically relevant safety narratives for clear, comprehensive documentation.
  • Application and adherence to Safety Data Exchange Agreements for compliance with regulatory standards.
  • Mentoring and onboarding of new team members to facilitate a smooth integration into processes.
  • Evaluation of timesheets to ensure accurate recording of work hours, and performance tracking.
  • Reconciliation of data for alignment across systems, and ensuring consistency in records management.

Education

Master of Pharma Regulatory Affairs - Drug Regulations, Intellectual Property Rights, Professional Skill Development, Quality Assurance

Manipal College of Higher Education
11-2013

Bachelor of Pharmacy -

Utkal University
06-2011

Skills

  • Regulatory compliance
  • Aggregate safety reporting
  • Data analysis
  • Pharmacovigilance practices
  • Medical writing
  • Quality assurance
  • Client collaboration
  • Cross-functional teamwork
  • Project management
  • Attention to detail
  • Effective communication
  • Multitasking

Websites

Certification

Udemy License for Pharmacovigilance Aggregate Reporting

Hobbies and Interests

  • Playing sports
  • Exploring cuisine
  • Reading books
  • Watching historical documentaries

Achievements

Winner of Badminton in National Pharmacy Week, Utkal University

Languages

English
First Language
Hindi
Upper Intermediate (B2)
B2
Odiya
Intermediate (B1)
B1
Telugu
Elementary (A2)
A2

References

References available upon request.

Timeline

Aggregate Safety Scientist

Accenture
11.2023 - Current

Medical Safety Writer

Qinecsa Solutions
03.2020 - 09.2023

Data Analyst

Cognizant
07.2018 - 02.2020

Scientific & Medical Writer - Grade 1

Crest Premdia Solutions (a part of Springer Nature)
07.2016 - 06.2018

Drug Safety Operational Specialist

Quintiles India Private Ltd.
11.2015 - 04.2016

Senior Drug Safety Associate

Synowledge LLC
08.2013 - 10.2015

Master of Pharma Regulatory Affairs - Drug Regulations, Intellectual Property Rights, Professional Skill Development, Quality Assurance

Manipal College of Higher Education

Bachelor of Pharmacy -

Utkal University

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Amrita Das