Rohitashwa Kumar
Senior Manager, Patient Safety Scientist
- Role
- Senior Manager, Patient Safety Scientist at AstraZeneca
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Rohitashwa Kumar
Masters in pharmacology with more than 12 years of comprehensive experience. Developed expertise in pharmacovigilance across various therapeutic areas for major pharmaceutical companies. Adeptly handled end-to-end pharmacovigilance activities, including safety surveillance, aggregate report generation (PBRER/DSUR), regulatory agency responses, various submissions (IND, NDA etc.), Health Hazard Evaluations (HHE), OTC switch assessments, structured benefit-risk assessments (sBRA), label evaluations (CCDS, SmPC), Eudravigilance monitoring, Adverse Drug Reaction (ADR) frequency determination, local and global literature review along with mentoring and talent management.Handling established complex products in AstraZeneca as scientist and SSaMT lead.Skills: safety aggregate reporting, signal and risk management, literature review, and individual case safety report (ICSR) processing. Leadership skills: Customer centric, Strategic management, Decision maker, Performance driver, Collaboration, Mentorship
Experience
Senior Manager, Patient Safety Scientist
Jul 2024 — Present · Bengaluru, IN
Education
Dr. A.P.J. Abdul Kalam Technical University
Bachelor’s Degree, Pharmacy
2007 — 2011
Dr. A.P.J. Abdul Kalam Technical University
Master’s Degree, Pharmacology
2011 — 2013
Skills
- Oncology
- CRO Management
- Dsurs
- Case Narratives
- Pharmaceutical Industry
- Coordination
- Psurs
- Clinical Monitoring
- Pharmacovigilance
- High-Performance Liquid Chromatography (Hplc)
- Gcp-Ich
- Rems
- Meddra
- Andas
- Regulatory Affairs
- Good Clinical Practice (Gcp)
- Animal Models
- Susar
- Team-Oriented
- Microsoft Office
- Icsrs
- Ich-Gcp
- Management
- Clinical Research
- Clinical Pharmacology
- Clinical Safety Data Management
- Pader
- Clinical Trials
- Quick Learner
- Pharmacology
- Ba/Be Studies
- Regulatory Submissions
- Ndas
- Medical Writing
- Clinical Development
- Quality Assurance
- Life Sciences
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