Ganesh Wagh
Passionate Drug Safety Professional with 13+ years of Experience In Managing End to End PV
- Role
- Assistant Manager at Apotex India
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Ganesh Wagh
Experienced PV professional with a demonstrated history of working in the pharmaceuticals industry and have expertise in Drug safety and Risk Management. Skilled in managing end to end PV activities starting from Medical information, ICSR management, Aggregate reports, Signal Management, Risk Management Plans, SDEA, Process Improvements, Vendor Management including operational activities such as SDEAs, upgrading Safety database, maintaining and updating PSMF, Regulatory Intelligence, CAPA management, Audit and inspections.
Experience
Assistant Manager
Oct 2024 — Present
Education
Saint Monica English High School Vaijapur Aurangabad
SSC
1991 — 2003
Mes College of pharmacy
Bachloer of Pharmacy
2006 — 2010
Skills
- Time-Efficient, Systematic Working Methodology
- Case Triaging and Case Processing for All Spontaneous Cases, Solicited Cases
- Rapid Adaptability to New Problem-Solving and New Locations
- Knowledge of Drug Development
- Proven Leadership and Human Management Skills
- Clinical Research
- Knowledge of Ich Gcp Guidelines and Fda Guidance Documents
- Narrative Writing, Self-Check of Online Qc Tool
- IT: Word, Excel, Windows, Ms Outlook
- Clinical Data Management
- Ich Gcp, Case Processing, Regulatary Affairs, Drug Safety, Reporting, Coding
- Strong Written and Verbal Communication Skills
- Pharmacovigilance
- Medical Coding
- Phases of Clinical Trials and Clinical Research Clinical Profession
- Quality Assurance
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