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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