1. 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.

2. 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

1. 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

- Any other duties assigned by the head of the department

4. Medico-Regulatory

- Preparation and Review of dossier and regulatory submission (Module 2,4 and 5)

- Preparation of documents for Export application,

- Preparation of SEC presentation,

- CTRI registration,

- SAE Reporting through SUGAM portal,

- Addressing regulatory queries

- Preparation the pack inserts and leaflets

- Assist medical team on projects

- Preparation the presentations as per the requirement

- Use of digital technology to prepare scientific/medical documents

📌 Clinical Research Associate (Mumbai)
🏢 Zuventus Healthcare
📍 Mumbai