Ajinkya Magdum
Safety Science Analyst
- Role
- Safety Science Analyst at Fortrea
- Location
- Pune Division, MH, IN
- LinkedIn followers
- 500 followers
About Ajinkya Magdum
I would like to explore Pharma domain and would like to use my knowledge for company as…
Experience
Safety Science Analyst
May 2023 — Present · Pune, IN
Performing case intake and triage of the incoming safety information or reports from various sources either spontaneously or from a clinical trial. Assisting with processing of the adverse events, including but not limited to: Data entry of safety data onto adverse event tracking systems.Assisting in the listedness assessment against appropriate label (for Marketed products, if applicable) and seriousness of the events. Assisted in generation of queries and collection of missing or discrepant information in consultation with medical staff, if neededWorking on Submission of expedited Serious Adverse Event (SAE) reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, Partners and Labcorp project personnel, as required within the agreed timelinesAssisting with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (Clients, Regulatory Authorities, Ethics Committees, investigators and Labcorp project personnel etc), and prioritise the reports for processing and submission within the regulatory and/or study specific applicable timelines. Assist in the reconciliation of databases, as applicableWorking within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc as appropriate.
Education
Rajiv Gandhi University of Health Sciences
Bachelor of Pharmacy - BPharm
2016 — 2019
Gopal Krishna Gokhale College,kolhapur
HSC
2012 — 2013
kle college of pharmacy ,Nipani
D.Pharma
2013 — 2016
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