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