Summary
Overview
Work history
Education
Skills
Certification
Accomplishments
DECLARATION
TECHNICAL SKILLS
Timeline
Generic
Josin Mary Simon

Josin Mary Simon

Abu Dhabi,United Arab Emirate

Summary

Experienced Pharmacovigilance professional known for enhancing compliance and ensuring patient safety through thorough data analysis and risk assessment. Seeking a responsible and challenging position in an organization that would enable to augment the acquired knowledge and offer opportunities for growth based on achievements.

Overview

5
5
years of professional experience
1
1
Certification

Work history

Drug Safety Associate II

Novo Nordisk Global Safety
Bangalore, India
01.2018 - 10.2021
  • Initial evaluation of reported adverse events (serious and non-serious) from all sources.
  • Case entry and verification of reported non-serious and serious adverse events.
  • Handled cases from clinical trial (Electronic Data Capture based; InForm), non-interventional studies, Pump-cart, haemophilia, trained in country specific conventions(United States).
  • Involved in reconciliation processes of clinical trial cases and date of birth review.
  • Part of affiliate support including booking in CCgloW, customer complaint form verification.
  • Accurate and consistent coding of all events for serious and non-serious cases entered in Argus with use of MedDRA (Medical Dictionary for Regulatory Activities) and evaluate causality, seriousness and listedness for all cases.
  • Ensure that case narrative comprises correct and appropriate safety information.
  • Time bound reporting of audit cases in-order to meet KPI as well as quality standards.
  • Assess the need for follow up information and issue follow up requests for cases.

Clinical Pharmacist Intern

PSG Hospitals
Coimbatore, India
12.2016 - 10.2017
  • Involved in ward rounds and dosage adjustments.
  • Pharmacovigilance and pharmacoeconomic evaluations
  • Monitored and counselled chronic disease patients, maximizing treatment efficacy.
  • Worked with Cardiology, Pulmonary, Gastroenterology, Nephrology, Neurology, General Medicine and Surgery departments to provide medications for patients, ensuring complete accuracy.

Education

Doctor of Pharmacy (PB) - Pharmacy

PSG College of Pharmacy, Dr. MGR Medical University
Coimbatore, India
10.2017

Bachelor of Pharmacy - Pharmacy

KMCH College of Pharmacy, Dr. MGR Medical University
Coimbatore, India
10.2014

Skills

  • Incident reporting systems (Triage)
  • Data review and interpretation
  • EMA MHRA Regulatory Submissions
  • Knowledge of relevant ICH-GCP modules
  • Process monitoring
  • Compliance oversight
  • Narrative writing
  • Medical Coding
  • Literature reviewing
  • Stringent time management
  • Mentoring new recruits

Certification

Registered Pharmacist (Dr.) with the Tamil Nadu Pharmacy Council



Accomplishments

  • MASTERS PROJECT “Pharmacoeconomic evaluation of antibiotics in microbial infection” PSG College of Pharmacy, Coimbatore, Tamil Nadu.
  • BACHELOR PROJECT “Modulatory effects of pregabalin on behavior against experimentally induced convulsion in mice” KMCH College of Pharmacy, Coimbatore, Tamil Nadu

DECLARATION

I, hereby declare that the above statements are true to the best of my knowledge and can be supported with relevant documents as and when required.


TECHNICAL SKILLS

  • Microsoft Office (Excel/ Word/ PowerPoint)
  • ARGUS Database
  • MedDRA
  • Veeva Vault Safety Database
  • Electronic Data Capture

Timeline

Drug Safety Associate II

Novo Nordisk Global Safety
01.2018 - 10.2021

Clinical Pharmacist Intern

PSG Hospitals
12.2016 - 10.2017

Doctor of Pharmacy (PB) - Pharmacy

PSG College of Pharmacy, Dr. MGR Medical University

Bachelor of Pharmacy - Pharmacy

KMCH College of Pharmacy, Dr. MGR Medical University

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Josin Mary Simon