Summary
Overview
Work History
Education
Skills
ADDRESS:
Languages
Accomplishments
References
Timeline
Generic

Ayan Pramanik

Kolkata

Summary

Experienced professional in Pharmacovigilance with 8.5 years in the field and B. Pharma and M. Pharma qualifications from Maulana Abul Kalam Azad University of Technology, WB. Expertise in Arisg, Sapphire, Argus, and Salesforce-IVP databases, developed through roles at Cognizant, Bioclinica, and IQVIA. Effective in managing ICSR cases for Drug, Device, and Vaccine initiatives, contributing to improved safety monitoring and adherence to regulations.

Overview

7
7
years of professional experience

Work History

Operations Specialist 1

IQVIA
Bangalore
11.2020 - 02.2024
  • Facilitated end-to-end management of clinical trial cases for various clients within an international team framework.
    Triage and book in cases with prompt client notifications while upholding data privacy protocols.
    Performed quality reviews of cases, integrating feedback from medical reviewers effectively.
    Accomplished sponsor submissions and MAH distributions of PV reports tailored to client requirements.
    Ensured compliance with submission timelines alongside country-specific guidelines.
    Managed queries raised to sites, tracking responses for timely follow-ups.
    Executed EDC reconciliation to enhance data reliability.
  • Implemented strategies to take advantage of new opportunities.
  • Created plans to propose solutions to problems related to efficiency, costs or profits.
  • Set specific goals for projects to measure progress and evaluate end results.
  • Maintained positive working relationship with fellow staff and management.
  • Assisted in the development and launch of new products or services from an operational perspective.
  • Conducted quality assurance checks to maintain high standards of service.
  • Supported project management activities from planning through execution.
  • Negotiated contracts with vendors and suppliers to reduce operational costs.
  • Coordinated with various departments to streamline operations and enhance workflow.
  • Managed daily operational tasks to ensure company efficiency and productivity.
  • Drafted communications regarding changes in policy or procedure updates for distribution throughout the organization.
  • Analyzed customer feedback to improve operations processes and increase customer satisfaction.

Senior Drug Safety Associate

Bioclinica
Mysore
05.2018 - 10.2020
  • Oversaw ICSR case handling from multiple sources, including CT, PMS, literature, social media, and legal aspects (conducted triage, data entry, quality reviews, and prioritized case assignments; served as back-up lead in CAPA and RCA discussions within team; facilitated training for new hires and conducted knowledge check assessments; coordinated preparations for audits and client interactions.
  • Mentored junior associates in drug safety protocols
  • Managed adverse event case processing and documentation
  • Conducted quality checks on drug safety reports
  • Provided training on pharmacovigilance systems and processes
  • Evaluated literature sources for post-marketing surveillance studies and summarizing findings into reports.
  • Reviewed product labeling documents for accuracy and completeness of safety information.
  • Maintained a database of all reported adverse events, ensuring accuracy and completeness of records.
  • Developed written procedures related to drug safety processes, including Standard Operating Procedures.
  • Identified areas where process improvements can be made within the Drug Safety Department.

Trainee Junior Data Analyst

Cognizant
Kolkata
08.2016 - 04.2018
  • Executed ICSR PMS case processing, focusing on medical safety and regulatory compliance.
    Gathered training reports from team to ensure ongoing compliance with industry standards.
    Contributed valuable inputs at team meetings, fostering a culture of continuous improvement.
    Prompted teams regarding newly adopted client conventions for better alignment.
    Organized engaging team-building events to promote unity and cooperation among members.
    Hosted PV convention quizzes and mind games as effective refresher training tools.
    Reviewed cases meticulously to guarantee adherence to quality benchmarks.
  • Collaborated with team members to gather and validate data from multiple sources.
  • Created visual reports using data visualization tools for stakeholder presentations.
  • Assisted in developing and maintaining databases for efficient data management.
  • Supported senior analysts in preparing detailed reports on project findings.
  • Participated in team meetings to discuss data insights and project progress updates.
  • Documented processes for data collection and analysis to enhance team efficiency.
  • Performed root cause analysis on identified anomalies within the dataset.
  • Generated ad-hoc reports upon request by management or other stakeholders using advanced Excel functions.

Education

Master of Pharmacy - Pharmacology

Maulana Abul Kalam Azad University of Technology
Bengal School Of Technology - Chuchura
05-2016

Bachelor of Pharmacy - Pharmaceutical Sciences

West Bengal University of Technology
Bengal School Of Technology - Chuchura
05-2014

Skills

  • Database management systems
  • Electronic data capture systems
  • Labeling documentation
  • CAPA and RCA tools
  • MedDRA coding
  • Apex Tracker proficiency
  • ICD-10 coding
  • XML file importation
  • WHO drug dictionary expertise
  • AI engine testing
  • Data visualization tools
  • Programming languages
  • Data privacy compliance
  • Team mentoring
  • Clinical trial management
  • Quality assurance

ADDRESS:

Permanent: Village: Chotokaliai, PO: Janigpur, PS: Raghunathganj, Dt: Murshidabad, West Bengal, PIN: 742213

Present : 38 North Purbachal, Kalitala Link Road, Kolkata, West Bengal, PIN 700078

Languages

English
Advanced (C1)
C1
Bengali
Native
Native
Hindi
Advanced (C1)
C1

Accomplishments

  • Multiple award owner in IQVIA Impact Program
  • Award owner in Cognizant for expectational work

References

References available upon request.

Timeline

Operations Specialist 1

IQVIA
11.2020 - 02.2024

Senior Drug Safety Associate

Bioclinica
05.2018 - 10.2020

Trainee Junior Data Analyst

Cognizant
08.2016 - 04.2018

Master of Pharmacy - Pharmacology

Maulana Abul Kalam Azad University of Technology

Bachelor of Pharmacy - Pharmaceutical Sciences

West Bengal University of Technology

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Ayan Pramanik