Summary
Overview
Work History
Education
Skills
Accomplishments
College Projects
Certification
Languages
Interest
Timeline
Generic
Sayantan Mandal

Sayantan Mandal

Hooghly

Summary

Pharmacy graduate with 1.7 years' experience as a Global Medical Device Complaint Handling Associate. Skilled in Evaluation, Investigation, and RA Creation, with a deep understanding of medical device regulations. Certified in Clinical Research, Pharmacovigilance, Medical Writing, and Regulatory Affairs. Seeking opportunities to apply expertise for mutual growth.

Overview

2
2
years of professional experience
1
1
Certification

Work History

Global Medical Device Complaint Handling Specialist, Associate

WIPRO
Kolkata
12.2022 - Current
  • Evaluate complaints with precision, ensuring proper coding and differentiation between complaint and non-complaint cases.
  • Analyses source notes and Salesforce Information to determine reportability and necessity of complaint splitting.
  • Communicate with RSE, FSE, Case Owners, and Customers via email to gather additional information.
  • Ensure timely submission of cases after coding and assign them to L1, L2 & L3 investigator according to their reportability.
  • Investigate complaints including root cause analysis, patient condition assessment, event timelines, customer solutions, and device repair.
  • Close complaints with detailed investigation summaries, notes, and coding.
  • Create RAs using CFM file and adhere to quality criteria during direct client interactions in Dutch, Benelux, & CEE markets.

Education

Bachelor of Pharmacy -

Ram-Eesh Institute Of Vocational & Technical Education
08.2021

Intermediate -

Goghat High School
04.2017

High School -

Kamarpukur Ramakrishna Mission Multipurpose School
04.2015

Skills

  • Knowledge of FDA Regulations
  • 21CFR 820
  • Medical Device Risk management
  • Salesforce
  • One Ems
  • SAP
  • Strong aptitude for MS Office applications
  • Effective team player
  • Excellent written and verbal communication skills
  • Familiar with EU MDR
  • IEC standards
  • ICH
  • GCP guidelines
  • Basic understanding of diseases

Accomplishments

  • Client Kudos: Recognized for timely submission and notification of Patient harm and Death cases.
  • Best Performer: Acknowledged for consistently delivering 100% quality in evaluations.

College Projects

Immunotherapy in COVID-19 Pandemic [04/2021 - 06/2021] 

Investigated the potential of various plant extracts and herbal-fed additives in enhancing protective antibody levels against COVID-19 and other infections. Explored the development of more effective cell-mediated immune responses for protection against bacterial, viral, and other diseases. Proposed that immunotherapy and herbal medicine could serve as complementary preventive therapies for COVID-19.

Certification

CliniWings - Clinical Research Training Institute [10/2021 - 12/2021]

"A 3 months of online course completion certificate
of basic concepts and workflow in the clinical Research, Clinical data management, Pharmacovigilance, Medical writing, Regulatory affairs from Cliniwings Coaching Institute(ISO and MSME certified) Pharma experts institute"

Languages

  • English Full Professional Proficiency
  • Hindi Limited Working Proficiency
  • Bengali Native or Bilingual Proficiency

Interest

  • Regulatory Affairs
  • Medical Device Complaint Handling
  • Vigilance Reporting

Timeline

Global Medical Device Complaint Handling Specialist, Associate

WIPRO
12.2022 - Current

Bachelor of Pharmacy -

Ram-Eesh Institute Of Vocational & Technical Education

Intermediate -

Goghat High School

High School -

Kamarpukur Ramakrishna Mission Multipurpose School

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Sayantan Mandal