Summary
Overview
Work History
Education
Skills
Creditable Mentions & Expertise
Timeline
Generic

ROSHAN M A

Manager, Pharmacovigilance
Meladthale house, Aranthodu P&V, Sullia, Dakshina Kannada (Mangalore)

Summary

I am looking for a challenging role in Pharmacovigilance where I can use my expertise to contribute to the organization's success and further develop my skills. With years of experience as a Team lead and Manager, I have strong leadership, strategic planning, and organizational abilities. I excel at empowering teams to efficiently handle tasks and meet customer needs. My knowledge of industry standards, market dynamics, and regulatory guidelines allows me to make data-driven decisions and troubleshoot operations effectively.

Overview

9
9
years of professional experience

Work History

Manager, Drug Safety & PV

Syneos Health
11.2021 - Current
  • Global Literature Monitoring SME and Manager

Pharmacovigilance Scientist

Teva Pharmaceuticals
7 2021 - 11.2021
  • Pharmacovigilance Medical Scientific Unit Safety Scientist (Global Patient Safety & Pharmacovigilance)
  • Literature review for Signals (Risk-Based Approach)

Drug Safety Scientist

Bioclinica
11.2018 - 07.2021
  • Literature activities lead (ICSRs & Risk-Benefit evaluation, QC), Signal management (Qualitative), Periodic reports support, HSR adjudication, CSR narrative writing
  • SPOC for all Literature related activities from both Client and Internal end
  • Involve in tool development, search strings development, SOPs preparation, training the new colleagues, involve in product trainings provided by the Clients

Senior Pharmacovigilance Associate

Kinapse, a Syneos Health Company
07.2015 - 11.2018
  • Literature Case Processor [EudraVigilance - E2B (R2) & (R3)]
  • Literature Screener (Medical Literature Monitoring)
  • Workflow Management
  • Data entry specialist for xEVMPD

Education

M. PHARM (Pharmaceutics) -

Rajiv Gandhi University of Health Sciences

B. PHARM - undefined

Rajiv Gandhi University of Health Sciences

Skills

Team Management

Creditable Mentions & Expertise

  • Certified Six Sigma Green Belt
  • Certificates of recognition for exceptional performance and valuable contributions to the Project/Internal initiatives
  • Trained on EudraVigilance - E2B (R3) database from the EMEA
  • MedDRA, GVP – Module VI and VII, CIOMS VIII, GVP – Module IX, EudraVigilance - E2B (R2) and E2B

Timeline

Manager, Drug Safety & PV

Syneos Health
11.2021 - Current

Drug Safety Scientist

Bioclinica
11.2018 - 07.2021

Senior Pharmacovigilance Associate

Kinapse, a Syneos Health Company
07.2015 - 11.2018

Pharmacovigilance Scientist

Teva Pharmaceuticals
7 2021 - 11.2021

M. PHARM (Pharmaceutics) -

Rajiv Gandhi University of Health Sciences

B. PHARM - undefined

Rajiv Gandhi University of Health Sciences
ROSHAN M AManager, Pharmacovigilance