Ashwini Navale
Pharmacovigilance associate at APCER life sciences | Ex- Cognizant | SME |Handling Intake, triage and Book in clinical trial cases,Rave EDC|Case Processor|Quality reviewer|Trainer|
- Role
- Pharmacovigilance Associate at Apcer Life Sciences
- Location
- Pune District, MH, IN
- LinkedIn followers
- 500 followers
About Ashwini Navale
Ready to work Learner Good communication Interactive Have experience in…
Experience
Pharmacovigilance Associate
Oct 2023 — Present · Ahmedabad, IN
Triage: Prioritize the cases as per case IRD, seriousness, and validity case.• Identifying duplicate/invalid ICSR and handling as per relevant SOP.• Preparation of the source document as per SOP.• Manages intake of Clinical trial cases in theEDC and Argus ICSR pending for further Book in and processing.• Identifying possible SUSAR and processed potential SUSAR cases.• Codes adverse events, suspect products, concomitant medications, medical history, and tests.• Clinical assessments which include case seriousness and causality.• Adverse event labelling with the use of Investigator Brochure (IB).• Safety narrative writing.• Raises follow up urgent queries based on criticality of missing information and Processing ofFollow up information.
Education
Sppu university
Master's degree
2020 — 2022
Sppu university
Bachelor's degree
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