Sumit Kumar Email & Phone Number

Mumbai, Maharashtra, India

• Responsible for pharmacovigilance activities in the Asia region and establishing and maintaining the pharmacovigilance system for products marketed in South Africa & Sub-Saharan countries.• To ensure compliance with legal requirements and oversee the functioning of the system.• Providing oversight of the pharmacovigilance quality system, including standard operating procedures, contractual arrangements, and compliance data.• Reviewing and approving changes to the pharmacovigilance system. • Preparation and finalization of PV agreements between the company and third parties.• Participate in global teleconferences and face-to-face meetings as required.• Preparation of local RMP and PSURs.• Submission of Periodic Safety Update Reports (PSURs) to the regulatory authorities according to regulations and standard operating procedures.• Preparation of training material and providing pharmacovigilance training (induction and refresher) to internal staff and external partners, as required.

Mumbai, Maharashtra, India

• Responsible for pharmacovigilance activities in the Asia region.• Responsible for the creation of a pharmacovigilance system in the organization.• Actively participate in departmental and various cross-functional projects that may include regulatory, sales and marketing, and medical affairs.• Ensure data accuracy, clinically valid case assessment, regulatory reporting status assessment, and ensure follow-up is completed on pharmacovigilance cases.• Report adverse events to the appropriate regulatory authorities and clinical study personnel according to regulations and standard operating procedures.• Submission of Periodic Safety Update Reports (PSURs) to the regulatory authorities according to regulations and standard operating procedures.• Maintain a log, compliance information, and filing system for all PV cases.• Preparation of PV SOPs and working instructions as required.• Preparation and finalization of PV agreements between the company and third parties.• Participate in global teleconferences and face-to-face meetings as required.• Preparation of training material and providing pharmacovigilance training (induction and refresher) to internal staff and external partners, as required.• Preparation of local RMP and PSURs.

Kolkata Area, India

• To supervise and coordinate all project-related activities. Communicate between the project manager and team.• Record, maintain, and track metrics for both team members and project performances. Following up with sites regarding outstanding queries and reconciliation of discrepancies Maintaining the data as per client-specific SOPs and guidelines.• Leave and workflow management.• Attend training sessions and develop capabilities on an ongoing basis. Preparation of a performance report as required.• Discussion of IT-related issues and their impact on a client call.• Responsibilities for monitoring the regional hubs in boxes for case intake and ensuring all emails are triaged and auctioned properly.

Pune, Maharashtra, India

• Implement and promote the use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures and assume accountability for the deliverables.• Ensure the compliance of operations with governing regulatory requirements.• Create, maintain, and assume accountability for a culture of high customer service.• Assist the team lead, project manager, or service delivery manager in overall project management and execute drug safety data management processes. A combination of medical coding, narrative writing, peer review, and a case follow-up report.• Preparation and submission to regulatory authorities, workflow management, identifying quality error trends, and conducting refresher training.• Assist the team project manager or service delivery manager in resource allocation within the project.• Assist and coordinate to ensure management volume peaks.• Assist the project manager or service delivery manager in managing day-to-day operations. Review of training files for respective team members.• Additionally, perform project-specific activities like training and training documentation-related activities as per project requirements.

Pune, Maharashtra, India

• Implement consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures.• Ensure the compliance of operations with governing regulatory requirements.• Create, maintain, and assume accountability for a culture of high customer service. Execute drug safety data management processes—a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation, and submission to regulatory authorities—with accountability for the quality and timeliness of deliverables and responsibility for process improvements.• Perform any other support activities as assigned, including tracking various types of information and metrics, ongoing QC of defined process steps, training, and reconciliation of data from multiple sources, including literature searches.

Pune Area, India

• To implement and promote the use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures.• To ensure compliance of operations with governing regulatory requirements, create, maintain, and assume accountability for a culture of high customer service.• To execute drug safety data management processes, A combination of case intake, triage, case entry, medical coding, narrative writing, peer review, call intake, case follow-up, report preparation, and submission to regulatory authorities.• To perform any other support activities as assigned, including tracking various types of information and metrics, ongoing QC of defined process steps, training, and reconciliation of data from multiple sources, including literature searches.

Mumbai, Maharashtra, India

• Identification of adverse events, serious adverse events, medication errors, productcomplaints, and special case scenarios, and working on them accordingly.•Assess and process all case types.•Prepare initial and follow-up case narratives.•QC of cases and AEM report forms for any kind of error.•Completion of the data from source documents, including a narrative (Narrative writing), complete detailing of the adverse event, selection of the event term, concomitant medications, and medical history against source documents

Master'S Degree, Pharmacy, A

Bachelor'S Degree, Pharmacy