Thursday, 6 December 2018

Vimta Labs – Urgently Hiring B.Pharm / M.Pharm Experienced Graduates

Vimta Labs – Urgently Hiring B.Pharm / M.Pharm Experienced Graduates – Medical Writer
Company Name : Vimta Labs

Job Type : Online Apply
Job Role :Medical Writer Position!
Qualification Required: B. Pharm / M.Pharm
Experience: 3+
Primary Responsibilities:
Prepare, edit and coordinate the production of Study Protocols.

Preparation of Protocol Synopsis with assistance of PI.

Developing Informed Consent Forms with adherence to protocol and Standard Operating procedures.

Develops study worksheets and source documentation tools.

Co-coordinating the ethics committee, who safeguard the rights, safety and wellbeing of all trial subjects.

Interacts with Bioanalytical and Biostatiscian team for protocol inputs.

Coordinate activities of personnel within Clinical Supplies, Clinical Reference Laboratory, Medical Communications, Regulatory Affairs, and Quality Assurance.

Briefing research staff on conducting the trial.

Providing Regulatory updates to Clinical team.

Preparation and Review of Clinical Study Reports.

Collection of AEs, Subject Disposition, Protocol Deviations, Dosing information from CRFs and TMFs.

Updating Safety database in MS Access.

Preparation of 2.7 Module tables as per regulatory requirements;

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