Kshitij Ph.D.’s Email & Phone

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Kshitij Ph.D.

Safety Analytics & Reporting Lead @ Shire

Kshitij Ph.D. Contact Details

Cambridge, Massachusetts
Safety Analytics & Reporting Lead @ Shire
Pharmacovigilance Scientist @ Purdue Pharma L.P.
Technical Writer @ Sanofi (Merial Division)
Professional Certificate @ Rutgers Graduate School of Management

•Reviewed/authored aggregate reports (PSURs, ASRs) and on specific safety issues) and performed cumulative safety reviews in preparation of responses to adhoc queries from regulatory agencies world-wide. Have an understanding of epidemiology relevant to Phamacovigilance (using comparative safety data and epidemiological study analyses). Have gained expertise in CIOMS and ICH guidelines, GCP guidelines, reporting rules. Participated in DIA 

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