ROLE DESCRIPTION :

A quality control reviewer analyses pharma regulatory documents relating to entire lifecycle of clinical trials intended for development of product or molecule such as Protocol, Investigator Brochure, Clinical Study Report, Common Technical Document Modules, Investigational Medicinal Product Dossier, Development Safety Update Report, Informed Consent Form etc.

PRINCIPAL ACCOUNTABILITIES :

Content, Consistency, Format and Scientific QC review of following documents:

Protocol and protocol amendments (all phases), ICFs, IBs, IMPD, CTD modules, CSRs (all 4 phases), benefit and risk assessment (BRA), Narratives, safety reports, Briefing package/book, registry protocol and reports, manuscripts, and global investigation plan (GIP).

- Ensure the rigorous standards of scientific process by taking part in peer-review system

- Uphold the integrity of document and thereby helping to maintain quality of data

- Help prevent ethical breaches and thereby maintaining the credibility of submissions

GENERAL REQUIREMENTS :

- Excellent written and verbal English communication skills (including understanding of Grammar)

- Well-versed with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and other applicable national or local regulatory requirements for scientific documents

QUALIFICATIONS:

Bachelor / Master's degree in Pharmaceutical Sciences, (M.Pharm. Pharm D., Ph.D.) or Life Science degree

SKILLS :

- Reasonable understanding of therapeutic area/medical conditions and sound knowledge of pharmaceutical sciences.

- Good knowledge of clinical trials and required regulatory submissions, its purpose and process.

- Analytical aptitude and clearly developed ability of reasoning

- Skill to frame adequate and apposite response or comprehensive review comments

- Must able to do exact and meaningful interpretation of the data

- Should have fundamental knowledge of statistics

- Overall responsible for the content and consistency check in document with very minimal errors

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