CPD

Role & responsibilities

• Monitoring the studies conducted at CROs in compliance with protocol, GCP and other requirements.
• Reviewing third party monitoring process and reports.
• Providing information to pharmacovigilance team on all the studies yielding safety information.
• Product handling & preparation of review of study protocol, ICF documents and other project specific documents.
• Literature collection and review.
• Handling of BE-NOC/DCGI filings and coordination.
• Handling regulatory queries.
• Evaluation of products based on literature review and providing the bio-cost.