Opening for the post of Executive – Medical Monitoring and Pharmacovigilance at SIRO Clinpharm, India

Company Name: SIRO Clinpharm

Company Website: http://www.siroclinpharm.com

Post Name: Executive – Medical Monitoring and Pharmacovigilance

Qualification: The incumbent should be an MBBS.

The core responsibilities for the position would be Safety and Medical Monitoring:

• Preparation of safety monitoring Plan in accordance with SIRO/applicable Standard Operating Procedures (SOP), Good Clinical Practice and local (Schedule Y) or applicable international regulations.
• Preparation of safety presentation for the investigators' meeting (IM) and for Site Initiation Visit (SIV). Making presentations at the IM.
• Preparation of Serious Adverse Event form as per the study protocol considering the template of the adverse event form and the SAE reconciliation plan.
• Generation of Periodic SAE listing and its submission to the Sponsor, sites and regulatory authorities and follow-up with monitor for ethics committee acknowledgments.
• Preparation of Annual safety update report as a part of Annual status report of the project to be submitted to the DCGI.

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Mail your resume to: hr_india@siroclinpharm.com