Nehal Sandanshi Email & Phone Number | Currently handling all the Crucial Project and Vendor Management activities With regards to Pharmacovigilance activities of organization includes, - Vendor reconciliation - Vendor billing and invoices - ICSR third party quality review - Literature review & reconciliation - ICSR Submissions (FDA, EMA, INDIA) and it's reconciliation - Preperation & Review of PSUR, PADER, RMP, REMS, Signal Detection report - Compliance metrix - Monthly PV expenditure report - SDEA & TA preparation, evaluation - PSMF preparation & evaluation Generation and submission of Literature, Clinical trial, and Spontaneous ICSR reports for the client and regulatory authorities when required. Ensured an accurate and timely reporting of Expedited safety reports to applicable Regulatory Authority (USFDA, EMA, PVPI & DCGI) with hands on experience in Argus 8.0, Aris-G, and Saphhire database.

Nehal Sandanshi

Currently handling all the Crucial Project and Vendor Management activities With regards to Pharmaco...
Bengaluru, Bengaluru, India

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Nehal Sandanshi’s Email snehal@concordbiotech.com

Nehal Sandanshi’s Phone Numbers +91 97259 9****

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Nehal Sandanshi’s Location Bengaluru, Bengaluru, India

Nehal Sandanshi’s Current Industry

Nehal Sandanshi’s Prior Industry Apcer Life Sciences | Cognizant | Tata Consultancy Services | Catalyst Clinical Services

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Assistant Manager Regulatory Affairs and Vendor Management Pharmacovigilance

Present

Senior Pharmacovigilance Associate

2017-08-01 00:00:00 - 2021-05-01 00:00:00

Drug Safety Specialist

2016-04-01 00:00:00 - 2017-08-01 00:00:00

Senior Process Associate (Drug Safety)

2014-11-01 00:00:00 - 2016-03-01 00:00:00

Pharmacovigilance Associate

2013-12-01 00:00:00 - 2014-06-01 00:00:00

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Nehal Sandanshi is a Currently handling all the Crucial Project and Vendor Management activities With regards to Pharmacovigilance activities of organization includes, - Vendor reconciliation - Vendor billing and invoices - ICSR third party quality review - Literature review & reconciliation - ICSR Submissions (FDA, EMA, INDIA) and it's reconciliation - Preperation & Review of PSUR, PADER, RMP, REMS, Signal Detection report - Compliance metrix - Monthly PV expenditure report - SDEA & TA preparation, evaluation - PSMF preparation & evaluation Generation and submission of Literature, Clinical trial, and Spontaneous ICSR reports for the client and regulatory authorities when required. Ensured an accurate and timely reporting of Expedited safety reports to applicable Regulatory Authority (USFDA, EMA, PVPI & DCGI) with hands on experience in Argus 8.0, Aris-G, and Saphhire database.

Nehal Sandanshi has prior
experience in the following industries:
Apcer Life Sciences | Cognizant | Tata Consultancy Services | Catalyst Clinical Services

Nehal Sandanshi has the following professional experience:
Concord Biotech | Apcer Life Sciences | Cognizant | Tata Consultancy Services | Catalyst Clinical Services