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

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Associate (Mumbai)
🏢 Emcure Pharmaceuticals
📍 Mumbai