Vignesh Govindarajalu
Lead safety physician for aggregate reports, Originator/Innovator Drugs & Medical Devices.
- Role
- Aggregate Safety Physician at Apcer Life Sciences
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Vignesh Govindarajalu
An experienced physician with 18 years of total experience [clinical ~4 years;…
Experience
Aggregate Safety Physician
Jan 2021 — Present · Ahmedabad, IN
Authoring and reviewing PSURs for medical devices.Preparation and review of PSUR (PBRER) for medical drugs.Preparation and review of signal reports, signal detection and evaluation.Medical review of ICSRs.
Education
Saint John's Vestry higher secondary school
12
1986 — 1992
RMMC (Rajah Muthiah Medical College)
Bachelor of Medicine, Bachelor of Surgery (MBBS)
Skills
- Pharmacovigilance
- Meddra
- Ich-Gcp
- Clinical Data Management
- Oncology
- Edc
- Medical Writing
- Cardiology
- Psur
- Medical Review
- Oracle Clinical
- CRO
- Team Leadership
- 21 Cfr Part 11
- Biologics
- Clinical Trials
- Medical Devices
- Signal Detection
- Aggregate Reports
- Gcp
- Regulatory Affairs
- Good Clinical Practice (Gcp)
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