Job Overview
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Expiration date
September 20, 2024
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Experience
2 Years, 5 Years
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Desired Qualification
Master’s Degree
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, summary 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 updates to Regulatory agency
Desired Candidate Profile:
- M. Pharm (Pharmacology) with Relevant Experience of 2-5 Yrs.
