Simran Kaur Email & Phone Number
Who is Simran Kaur? Overview
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Simran Kaur is listed as QA Associate at Nivagen Pharmaceuticals, Inc., based in Antelope, California, United States. AeroLeads shows a matched LinkedIn profile for Simran Kaur.
Simran Kaur previously worked as Sr.Drug Safety Executive at Fidelity Health Services and Clinical Product at Fitterfly. Simran Kaur holds Master'S Degree, Pharmacy from University Of Mumbai.
Email format at Nivagen Pharmaceuticals, Inc.
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About Simran Kaur
An experienced and talented person with strong technical and leadership experience in the field of Pharmacovigilance and clinical research , I possess in depth knowledge of Pharmacovigilance from single case processing,, literature review, regulatory medical writing, CME, medical devices.I am a medical professional with a Master's degree in pharmacy. I also possess excellent communication skills and aim to build and nurture long term relationships with clients.Having worked with established multinationals and startup companies, flexibility and organized work are my key strengths.Having proven people management skills, 1 am comfortable working with people at all levels and have the ability to manage performance and motivate staff on an individual and a team level.I aim to work closely with clients from all geographical regions and also aim to work towards comprehensive and robust solutions.Safety database knowledge: ArgusArea of expertise: Spontaneous cases triage, Literature aggregate report assessment, Literature review expert, triage, causality assessment, data entry, mentoring and team management. data entry of Individual Case Safety Reports (ICSR's), writing the narratives, and quality review of spontaneous, literature, clinical trial, and study (Serious and non-Serious) cases. Detailed knowledge of PV following the strict client specific/FDAguidelines. Proficiency in ICH, GVP, GCP,EMA, and US FDA guidelines. In-depth knowledge of Argus and ERP.
Simran Kaur's current company
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Simran Kaur work experience
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Sr.Drug Safety Executive
- Managed drug safety data analysis and reporting, contributing to the success of the Pharmacovigilance life science department by tracking and maintaining quality metrics.Conducted CAPA investigations, root cause.
- Revolutionized documentation management for 20+ drugs in diverse therapeutic areas like Biooncology, Immunology, Ophthalmology, Virology & Neurology, streamlining data collection for regulatory compliance.
- Conducted rigorous quality system audits for medical devices and combination products, ensuring adherence to regulatory standards.Managed monthly client meetings as a US affiliate and adeptly handled relationships with.
Clinical Product
Knowledge about use of medical devices and healthcare technology also have a wide knowledge about clinical product and trials
Project Trainee
I have worked in Analytical Development Department. As I have also completed my M pharm Project too I learned handling of various Instruments also gained knowledge how a method gets developed for analysis of a drug and various validation parameters.
Qa/Qc And Cmc Intern
- Completed one-month Industrial training across all manufacturing departments and QA/ QC, including the Microbiology department.Examined QA documents like SOPs,sampling reports, and change control to ensure successful.
- & Assisted in manufacturing, quality control, and packaging areas of tablet production, strictly adhering to Good Manufacturing Practices (GMPs).
- Collaborated with cross-functional teams in manufacturing, quality control, and packaging departments to ensure compliance with GMPs during tablet production.
- Assisted in maintaining the quality and safety of tablet production by following GMPs in manufacturing, quality control, and packaging processes. I was a trainee in Quality Assurance Department My role was to read SOP.
Simran Kaur education
Master'S Degree, Pharmacy
Bachelor'S Degree
Frequently asked questions about Simran Kaur
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What company does Simran Kaur work for?
Simran Kaur works for Nivagen Pharmaceuticals, Inc..
What is Simran Kaur's role at Nivagen Pharmaceuticals, Inc.?
Simran Kaur is listed as QA Associate at Nivagen Pharmaceuticals, Inc..
Where is Simran Kaur based?
Simran Kaur is based in Antelope, California, United States while working with Nivagen Pharmaceuticals, Inc..
What companies has Simran Kaur worked for?
Simran Kaur has worked for Nivagen Pharmaceuticals, Inc., Fidelity Health Services, Fitterfly, Umedica Laboratories, and Maneesh Pharmaceuticals Ltd..
How can I contact Simran Kaur?
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What schools did Simran Kaur attend?
Simran Kaur holds Master'S Degree, Pharmacy from University Of Mumbai.
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