Susmita Kar
Chennai
Summary
Dynamic Senior Pharmacovigilance Reporting Associate at ICON Clinical Research, with expertise in safety reporting and risk assessment. Proven track record in client communication and project management, driving successful project outcomes. Adept at regulatory compliance and training development, ensuring high-quality deliverables and stakeholder satisfaction. Passionate about enhancing safety processes and team collaboration.
Overview
6
6
years of professional experience
Work History
Senior Pharmacovigilance Reporting Associate/Safety Supervisor
ICON Clinical Research
Chennai
10.2024 - Current
- Expertise (SME) in medical device regulations, project setup, maintenance, and closeout activities.
- Effectively manage the revenue activity of the projects and invoicing to clients.
- Effectively manage the revenue activity of the projects and invoicing to clients. Interact effectively with client project management and technical personnel.
- Provide recommendations for the planning, management, tracking, and reporting of projects.
- Facilitate internal meetings effectively, and deliver engaging, informative presentations.
- Involved in the review of RFPs (Requests for Proposals) and provided costing to the safety reporting group.
- Argus trainer for the new employees. As a presenter in the pre-qualification audits.
- As the author, I will draft the Standard Operating Procedures (SOPs) and Working Procedures (WPs).
- Maintenance of different trackers as per requirement.
Pharmacovigilance Reporting Associate
ICON Clinical Research
Chennai
07.2022 - 10.2024
- Served as safety reporting lead for multiple stand-alone projects, providing management support as designated
- Served as the primary point of contact for clients over meetings and emails, ensuring effective communication and satisfaction.
- Monitored, evaluated, and proposed mitigation strategies to manage risks affecting PV project deliverables and finances.
- Maintained budget and financial oversight for assigned projects, collaborating with teams on contractual activities such as change notifications, contract modifications, and renewals.
- Worked on the project's financial scope; negotiated scope increases to drive gross profit and revenue margins.
- Detecting revenue gaps and finding solutions for the margins.
- Directed timelines, tasks, and deliverables for safety reporting in PV functions.
- Participation and attendance at client audits, inspections, and business development meetings.
- Coordinating with other functional groups on project issues for a harmonized response.
- Developed PV and regulatory requirements, including contracted activities and project outputs.
- Collaborated with all PV functions to ensure key performance indicators were met as agreed.
- Trained new members to understand the process.
Drug Safety Associate II
Clario
Remote
03.2021 - 07.2022
- Data entry of individual case safety reports into the safety database (Sapphire, Veeva Vault, Aris G).
- The referring to the guidelines of the Health Authority and performing submission in accordance with Regulatory Intelligence.
- Performing submission via web trader and email submission.
- Tracking acknowledgment and attachments.
- Reconciliation of the submission data.
- Complying with the regulatory timelines.
- Initiate partner reconciliation, and respond to the partner in case of discrepancies.
- Submission of expedited reports and periodic reports (DSUR, Quarterly)
- Working on RCA, CAPA and 5 why sheet
Junior Data Analyst
Cognizant Technology Solution
Kolkata
10.2018 - 03.2021
- Data entry of individual case safety reports into the safety database (Aris G).
- Prioritizing cases and not missing the internal and external timelines.
- Writing a medically relevant safety narrative of cases, and checking the completeness and accuracy of the data entered in the various fields.
- Coding all medical history, events, indications, lab data, and procedures using Medra.
- WHO discretionary for coding suspect drugs, and company discretionary for coding co-suspect and concomitant medications.
- Initiate follow-up activities to obtain additional information and clarification, as appropriate.
- Initiate partner reconciliation, and respond to the partner in case of discrepancies.
Education
Bachelor of Pharmaceutical Technology -
Maulana Abul Kalam Azad Institute of Pharmaceutical Technology
West Bengal07.2018
Skills
- Microsoft Word
- Fluent Communication
- Critical Thinking
- Project management
- Safety reporting
- Client communication
- Regulatory compliance
- Risk assessment
- Audit participation
- Training development
- Team collaboration
Disclaimer
I, Susmita Kar, hereby declare that the details furnished above are true and correct to the best of my knowledge and belief. 2025
Timeline
Senior Pharmacovigilance Reporting Associate/Safety Supervisor
ICON Clinical Research
10.2024 - Current
Pharmacovigilance Reporting Associate
ICON Clinical Research
07.2022 - 10.2024
Drug Safety Associate II
Clario
03.2021 - 07.2022
Junior Data Analyst
Cognizant Technology Solution
10.2018 - 03.2021
Bachelor of Pharmaceutical Technology -
Maulana Abul Kalam Azad Institute of Pharmaceutical Technology
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