Associate

Operational (BE, CT and Toxicity study):

• Clinical trial sites qualification and selection.
• Site initiation and study monitoring
• Response to site/CRO/EC query, Review of TMF, source notes, study data
• Protocol/GCP Training, Study Planning for study activities
• Investigational product management
• Tracking the BE study and clinical trial activities
• Monitoring and auditing BE study and clinical trial sites
• Preparation and amendment of SOPs for clinical trial activities.
• Co-ordinate with investigators/CRO for the initiation and conduction of clinical trials
• Co-ordination with the CRO for timely completion of the study activities
• Addressing investigator/ethics committee queries
• Archiving study documentation and correspondence
• Source Data Verification: Verifying that data entered in the CRFs is consistent with source data
• Analyzing the clinical study data and resolving the discrepancies
• Negotiation for study quotation, budget with CRO, study center Tracking of trial agreements, budget, payment to CRO, study center, Laboratory, journal publisher.

Medical Writing (BE and CT)

• Study plan for proposed studies
• Extensive literature searches for medical writing;
• Protocol Designing; Case Report Form (CRF) Designing; Preparation of study-related documents
• Preparation of dossier/documents for regulatory submission
• Review of clinical study reports;
• Preparing manuscripts for publication;
• Review of BA/BE protocols as per the regulatory requirements

Pharmacovigilance

• Take part in the management of the pharmacovigilance (PV) function.
• Oversee the collection, documentation, and reporting of adverse event cases from various sources
• Coordinate the preparation and submission Individual Case Safety Reports (ICSRs) to regulatory authorities within stipulated timelines.
• Coordinate the preparation and submission of Periodic Safety Update Reports (PSURs)
• Analyze safety data and prepare reports for regulatory submissions
• Develop, implement, and monitor Risk Management Plans
• Ensure compliance with global pharmacovigilance regulations and guidelines
• Maintain and revise SOPs for pharmacovigilance processes.
• Draft, review, and maintain pharmacovigilance agreements with CRO, business partners, distributors, and license holders
• Lead preparations for pharmacovigilance audits and inspections by internal and external regulatory bodies
• Address response to regulatory query, audit findings and implement corrective and preventive actions
• Conduct training sessions for internal teams on AE reporting, pharmacovigilance processes, and regulatory requirements
• Preparation of training content for medical representative.
• Respond to regulatory authority queries related to PV
• Monitor the safety of products during clinical trials and post-marketing
• Maintain and update the pharmacovigilance database with AE reports and related data
• Document safety concerns when product recalls/withdrawals, and ensure timely regulatory communication

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