Clinical Research - Executive Torrent Pharmaceuticals

2.0 - 6.0 years

5 - 7 Lacs

ahmedabad, gujarat, india

On-site

Job description Role & responsibilities Feasibility assessment/ new product evaluation Literature review and BA/BE study designing BE Study Monitoring Preparation of documents for regulatory submission (i.e BENOC, Import license application etc.) Establishment and maintenance of study documents Document preparation for dossier submission (i.e clinical overview, non-clinical overview, summery tables etc.) Review of BE study documents i.e protocol, reports, ICF etc. Preparation/review of medical write up Coordination for serious adverse event reporting and safety update to Regulatory agency

Posted 1 month ago

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Medical Safety Expert Novartis India

3.0 - 7.0 years

0 Lacs

hyderabad, telangana

On-site

You will be responsible for providing support for medical safety management within the Patient Safety & Pharmacovigilance department. This includes conducting medical review and assessments of Individual Case Safety Reports (ICSR), aggregate reports, co-authoring safety documents, and assisting in providing safety input to regulatory and clinical documents, as well as ad-hoc Health Authority queries. Your role will involve creating quality deliverables within agreed timeframes and maintaining a high standard of accuracy in compliance with patient safety business rules, standard operating procedures, and global and local regulatory requirements. Additionally, you will be supporting in definin...

Posted 3 months ago

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