Summary
Overview
Work History
Education
Skills
Accomplishments
Languages
Personal Information
References
Timeline
Generic

Madhusudhan BG

Mysuru

Summary

Dynamic Project Manager with a proven track record at L&T Technology Services, excelling in resource management and regulatory compliance. Expert in pharmacovigilance and cross-functional collaboration, I drive successful project execution and business development, ensuring quality standards are met while fostering strong stakeholder relationships.

Overview

12
12
years of professional experience

Work History

Project Manager

L&T Technology Services
Mysuru
10.2024 - Current
  • Accountable for resource management of 230 personnel, including ownership of billing cycles and invoicing accuracy.
  • Developed detailed project plans, timelines, and resource allocation strategies to ensure successful project execution.
  • Implemented risk management processes to identify potential issues early and develop mitigation strategies.
  • Led cross-functional teams to deliver projects on time and within budget in the sector.
  • Coordinated with stakeholders including vendors, clients, and internal departments to align project objectives and expectations.
  • Monitored project progress using KPIs and project management tools to ensure adherence to quality standards.
  • Facilitated regular project meetings, status reports, and communication to keep all parties informed and engaged throughout the project lifecycle.

Tech Lead

L&T Technology Services
Mysuru
10.2021 - 09.2024
  • Led a team of 60 professionals in executing complaint handling processes for Class II medical devices, ensuring regulatory compliance and seamless daily coordination with client stakeholders.
  • Worked as a individual contributor as vigilance reporting specialist.
  • Applied working knowledge of TrackWise and SAP systems to facilitate submission of regulatory reports including eMDR, MIR, and IRIS.
  • Contributed to business development efforts by preparing tailored proposals for prospective clients.
  • Strategically planned and delivered project milestones in alignment with client expectations and quality standards.
  • Spearheaded clinical documentation initiatives for a top-tier pharmaceutical company, including authorship of PMS plans, PMCF plans, and PMCF reports in accordance with EU MDR guidelines.

Operations Specialist

IQVIA
Bengaluru
09.2018 - 10.2021
  • Successfully led and coordinated four clinical studies involving Class III drug-coated medical devices, ensuring alignment with global safety regulations and corporate compliance standards.
  • Managed end-to-end case entry workflows, including booking, documentation, and quality review processes.
  • Handled complaint processing, device deficiency assessments, and regulatory reporting, including BfArM submissions for Austria.
  • Maintained consistent client engagement through weekly core team calls with project managers and direct consultations with the sponsor's medical director to evaluate primary endpoint rates.
  • Played a key role in initiating new study start-ups and executing comprehensive study closeout activities.
  • Ensured all operations adhered to international regulatory guidelines and internal quality protocols.

Senior Drug Safety Associate

Bioclinica India Pvt. Ltd
Mysuru
11.2013 - 08.2018
  • Conducted comprehensive quality reviews of adverse event cases, ensuring strict adherence to global safety regulations, company SOPS, and regulatory guidance.
  • Managed end-to-end case intake operations including duplicate checks, registration, and documentation tracking.
  • Processed individual case safety reports (ICSRs), performing medical coding, safety narrative writing, and expedited status assessments in alignment with client protocols.
  • Applied MedDRA and WHO-DD dictionaries for accurate coding of medical history, events, drugs, procedures, and lab tests.
  • Authored medically relevant safety narratives and ensured completeness and accuracy of case data across multiple fields.
  • Led quality control initiatives, trained data entry teams, provided performance feedback, and executed CAPA documentation and late case analysis.
  • Therapeutic expertise across CNS, Endocrinology, Immunology, Oncology, and Cardiology domains.

Education

M.Pharma -

RGUHS
01.2013

B.Pharma -

RGUHS
01.2011

Skills

  • Pharmacovigilance and complaints handling
  • Project and resource management
  • Regulatory compliance
  • Billing and invoicing
  • Business development
  • Cross-functional collaboration

Accomplishments

Directed a team of 60 professionals in Medical Devices Class II complaints handling, ensuring full regulatory compliance and smooth client coordination. Based on the output given client awarded additional projects with headcount of 170 across different business units.

Languages

  • English
  • Kannada
  • Hindi
  • Marathi

Personal Information

  • Date of Birth: 11/03/88
  • Gender: Male
  • Nationality: Indian

References

References available upon request.

Timeline

Project Manager

L&T Technology Services
10.2024 - Current

Tech Lead

L&T Technology Services
10.2021 - 09.2024

Operations Specialist

IQVIA
09.2018 - 10.2021

Senior Drug Safety Associate

Bioclinica India Pvt. Ltd
11.2013 - 08.2018

M.Pharma -

RGUHS

B.Pharma -

RGUHS

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