Indu Sharma

- Trained in the management of regulatory information for Medicinal Products, Vaccines, Devices, and Nutraceuticals, which includes performing data entry in the Veeva Vault.

- Trained in DM (Document management), ADMS (All dossier management system), SCP (Submission content plan) creation, and CMC (chemistry, Manufacturing, and controls) activities. Support global users on Veeva vault activities.

- Trained in creating Core packages and linking final dossier-related activities, event impact assessments, and submissions in the Veeva vault.

- Experienced drug safety professional in pharmacovigilance including assessment and review of late Individual Case Safety Reports (ICSRs) as per the International and Local regulatory requirements.

- Expertise in assessing ICSR’s lateness reasons within the Compliance Monitoring tool in the ARISg Safety database which assists in compiling Regulatory Metrics (EMA, FDA, MHRA, etc.) to ensure adherence to internal/external standards and regulatory requirements. Support PV inspections and Audits and other allied activities.

- Trained in managing ICSRs of various case types (spontaneous, E2B, clinical studies, solicited program, and literature cases) including triage, coding, validation, and quality review of ICSRs.

- Proficient in reviewing the lateness reason and responsible organization for each workflow activity (Inbound receipt and triage, adverse reaction information system global to outbound submissions tracking) in accordance with the conventions, guidelines, and standard operating procedures.

- Assigning the overall lateness reason and responsible organization for late ICSRs

- Reassessing and changing the lateness reasons or responsible organization if assessed incorrectly by the Drug Safety Associate (DSA) at the time of case closure at his/her end.

- Handling ad-hoc requests from the Client regarding compliance investigations, as applicable

- Identifying and tracking trends in errors and late case reports in collaboration with the client contact

- Working knowledge of the client procedures and international drug safety regulations including:

- ICH guidelines on safety and efficacy

- FDA guidelines

- CIOMS

- New EU PV legislation

- GVP Modules

Maintaining awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting.

Trained in the management of ICSRs, including processing ICSRs in the safety database, determining the expectedness of adverse events against various labeling documents, writing case summaries, and assessing causalities if required.

Trained in MedDRA coding by 'MedDRA guidelines'.

Expertise in handling the ERP (Enterprise Resource Planning) system.

Query Management

- Interacting with appropriate client personnel to resolve issues related to the processing of Late ICSR

- Responding to the clients/customers promptly.

- Provide live support to global users for their Veeva Vault activities.

Experienced Clinical Research Coordinator with a strong background in managing and coordinating clinical trials.

• Adept at ensuring protocol adherence, patient safety, and regulatory compliance. Skilled in data management, patient recruitment, and supporting principal investigators in the execution of clinical studies.
• Demonstrates a thorough understanding of Good Clinical Practice (GCP) guidelines and has a proven ability to collaborate effectively with cross-functional teams to achieve study objectives.”

• Dedicated Pharmacy Assistant Professor with experience in delivering high-quality education in pharmaceutics and pharmaceutical sciences.
• Responsible for developing and teaching course materials, guiding student research, and mentoring students in both academic and professional growth.
• Proficient in conducting lectures, organizing practical labs, and integrating real-world applications into the curriculum.
• Committed to staying updated with the latest industry developments and fostering a collaborative learning environment that encourages critical thinking and innovation in pharmaceutical research.

• Clinical Research Coordinator with a strong background in managing and coordinating clinical trials.