Sonia Vanwari Email & Phone Number

Hyderabad, Telangana, India

CAPA Owner, CAPA Investigator, SRC, IGT ,DXR, CT- AMI Medical devices vigilance regulatory FDA, EU, Australia, Canada and ROWreporting/submission/closure.• Well-versed in SAP, E-submitter and other tools required for regulatory submission.• Post marketing surveillance for Philips SRC Medical devices.• Well-versed in regulatory submission guidelines and ISO 13485 QMS.• Submission of ISCR’s daily to FDA with 100% quality and productivity.• Well-versed in Power Bi and other… Show more CAPA Owner, CAPA Investigator, SRC, IGT ,DXR, CT- AMI Medical devices vigilance regulatory FDA, EU, Australia, Canada and ROWreporting/submission/closure.• Well-versed in SAP, E-submitter and other tools required for regulatory submission.• Post marketing surveillance for Philips SRC Medical devices.• Well-versed in regulatory submission guidelines and ISO 13485 QMS.• Submission of ISCR’s daily to FDA with 100% quality and productivity.• Well-versed in Power Bi and other tools and CAPA management and QMS for productivity and quality management.• Knowledge of Regulations/ guidance documents released by Health Authorities of different countries.Also worked as a quality review. Show less

Kolkata, West Bengal, India

• Processing of adverse event reports from Spontaneous, Health Authority, LicensePartner, Patient Oriented Program, Post Market Surveillance, and CAPA Analysis.• Experienced in data entry and investigates customer complaints, makes initial reportingdecisions, facilitates investigations and ensures consistency and completeness of thedocumentation for complaints.• Responsibility for day-to-day processing complaints from all Global locations. Ensurecomplaints are processed… Show more • Processing of adverse event reports from Spontaneous, Health Authority, LicensePartner, Patient Oriented Program, Post Market Surveillance, and CAPA Analysis.• Experienced in data entry and investigates customer complaints, makes initial reportingdecisions, facilitates investigations and ensures consistency and completeness of thedocumentation for complaints.• Responsibility for day-to-day processing complaints from all Global locations. Ensurecomplaints are processed thoroughly and timely in compliance with departmentalprocedures.• Perform preliminary classification of complaints, follow up with customers for requiredinformation and product returns, maintain complaint records and all supportingdocumentation, assign additional actions as necessary to close complaint. Show less

Kolkata, West Bengal, India

Processing Suspected Unexpected Serious Adverse Reaction (SUSAR) cases in clinical studies, strictly compliant to 7-Day and 15-Day timelines. MedDRA coding and Narrative writing, processing different cases like E2Band literature cases. Assessing causality and expectedness of adverse events as per documents like IB, CCDS, Smpc, and USPI. Adverse event (AE) coding by MedDRA browser and drug coding by WHO-DD browser, working on ARGUS safety database and indications… Show more Processing Suspected Unexpected Serious Adverse Reaction (SUSAR) cases in clinical studies, strictly compliant to 7-Day and 15-Day timelines. MedDRA coding and Narrative writing, processing different cases like E2Band literature cases. Assessing causality and expectedness of adverse events as per documents like IB, CCDS, Smpc, and USPI. Adverse event (AE) coding by MedDRA browser and drug coding by WHO-DD browser, working on ARGUS safety database and indications and patient history based on MedDRA. Show less

Raipur, Chhattisgarh, India

Work as a clinical pharmacist where i use to chemical mixing, Dose preparation

Dehra Dun, Uttarakhand, India

Paonta Sahib, Himachal Pradesh, India

B-Phamrmacy, A+

I completed my graduation from Shri rawatpura were i study about pharmaceutical sciences, human anatomy, medicinal chemistry, organic.

Zoology/Animal Biology, A+

i did my 10th and 12th higher school studies were i used to study PCB