Minu Mohanan
Signal Detection | Aggregate report PSUR PBRER| Risk management plan| I Case Processing| Database Trainer
- Role
- Global Safety Senior Manager at Amgen India
- Location
- Thane, MH, IN
- LinkedIn followers
- 500 followers
About Minu Mohanan
Strategic and highly experienced medical writer with 15+ years dedicated to pharmacovigilance and drug safety. My expertise spans the complete PV lifecycle, from ICSR case management through aggregate reporting (PBRER/PSURs, PADERs) and signal management. I am adept at authoring and critically reviewing Signal Assessment Reports and Risk Management Plans (RMPs), ensuring regulatory compliance and proactive risk mitigation. My reputation is built on perseverance, attention to detail, and a commitment to excellence, driving high-quality documentation that directly enhances patient safety and supports clinical research success.
Experience
Global Safety Senior Manager
Nov 2025 — Present · Hyderabad, IN
Education
Sikkim Manipal University - Distance Education
MBA, Operations Management
2010 — 2012
University of Mumbai
Bachelor of Science - BS, Biotechnology
2004 — 2009
Harvard Medical School
HMX Fundamentals program (Harvard Medical School online learning platform) – Pharmacology
Sikkim Manipal University - Distance Education
Post Graduation, Diploma in Clinical Research and Regulatory Affairs
2009 — 2010
Skills
- Argus
- Software Documentation
- Word
- Microsoft Word
- Microsoft Office
- Pharmacovigilance
- Pharmaceutical Industry
- Drug Safety
- Clinical Research
- Healthcare
- Regulatory Requirements
- Teamwork
- Team Management
- Meddra
- Clinical
- Quality Assurance
- Microsoft Excel
- Powerpoint
- Databases
- Customer Relations
- Clinical Trials
- Training
- Healthcare Information Technology
- Excel
- Gcp
- Team Building
- Leadership
- Documentation
- Biotechnology
- Compliance
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