Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
Generic

Sobin Mathew JAMES

Cambridge,ON

Summary

Drug Safety Specialist with over 3 years of hands-on experience in pharmacovigilance and a decade of healthcare industry exposure. Adept in ICSR processing, narrative writing, CAPA implementation, and global regulatory compliance, including Health Canada submissions. Proven ability to conduct PV trainings, update SOPs, and liaise with cross-functional stakeholders. Committed to upholding GVP, ICH, and GMP standards with a strong focus on data integrity, compliance, and continuous quality improvement.

Overview

10
10
years of professional experience

Work History

Drug Safety and Medical Information Specialist

Bayshore Healthcare
11.2022 - Current
  • Review and submit diverse ICSRs, including spontaneous, literature-based, and study cases, achieving a 100% on-time submission rate.
  • Maintain rigorous compliance with Health Canada reporting standards while addressing and resolving stakeholder and manufacturer queries.
  • Conduct root cause analyses for non-conformance's and establish CAPAs, improving operational compliance and audit readiness.
  • Develop, review, and optimize SOPs and Work Instructions, ensuring they align with evolving regulatory requirements.
  • Organize regular meetings within the team attend client meetings from time to time. Lead comprehensive training programs for staff, fostering a culture of excellence and compliance.
  • Coordinate weekly and monthly reconciliations, ensuring seamless alignment with client and regulatory timelines.
  • Managed medical inquiries to provide accurate information supporting patient care decisions.
  • Developed and maintained comprehensive databases for drug information and adverse event reporting.

Processing Operator

Johnson & Johnson
01.2022 - 02.2023
    • Executed raw material processing in adherence to cGMP guidelines, maintaining exceptional quality and safety standards.
    • Managed accurate and timely documentation of batch processes using PAS-X and SAP, ensuring 100% compliance during audits.
    • Investigated deviations, out-of-specification (OOS) results, and implemented CAPAs to prevent recurrence and improve system integrity.
    • (Part-time)

Assistant Manager

Welso Medicine & Wellness Store
05.2021 - 09.2021
  • Directed daily operations, ensuring regulatory compliance, customer satisfaction, and sales target achievement.
  • Developed and updated SOPs to enhance operational efficiency and maintain regulatory standards.

Pharmacy & Store Manager

Starcare Hospital, Muscat
09.2015 - 02.2021
  • Spearheaded pharmacy operations, including inventory control, vendor management, and regulatory compliance for controlled substances.
  • Designed and delivered GCP training programs for pharmacists, achieving a 25% improvement in compliance metrics.
  • Reduced inventory waste by 15% through the implementation of data-driven procurement strategies.
  • Collaborated with cross-functional teams to establish and license new pharmacies, expanding operational reach.
  • Facilitated ADR reporting and follow-ups, improving pharmacovigilance workflows by 20%.

Education

Master of Science - Pharmacology

Sheffield Hallam University, United Kingdom
Sheffield
01.2012

Bachelor of Science -

KMCH College of Pharmacy
India
09.2009

Skills

  • Pharmacovigilance Expertise: End-to-end ICSR processing, literature surveillance, safety reporting, MedDRA Coding
  • Quality Management: RCA, CAPA implementation, SOP, WI development, & process optimization
  • Training & Leadership: staff training, stakeholder engagement, and team motivation
  • Documentation Excellence: Proficient in PAS-X, SAP, and advanced MS Office Suite
  • Project Management: Quality Management & Documentation

Accomplishments

  • Consistently ensured 100% compliance with ICSR reporting timelines and quality standards.
  • Successfully developed and implemented CAPAs, reducing operational errors by 22%.
  • Delivered pharmacovigilance training sessions, improving team efficiency and compliance.
  • Improved SOP adherence by streamlining processes and enhancing team training programs.

Timeline

Drug Safety and Medical Information Specialist

Bayshore Healthcare
11.2022 - Current

Processing Operator

Johnson & Johnson
01.2022 - 02.2023

Assistant Manager

Welso Medicine & Wellness Store
05.2021 - 09.2021

Pharmacy & Store Manager

Starcare Hospital, Muscat
09.2015 - 02.2021

Master of Science - Pharmacology

Sheffield Hallam University, United Kingdom

Bachelor of Science -

KMCH College of Pharmacy

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Sobin Mathew JAMES