Ilma Kauser
Drug safety scientist I
Faridabad
Summary
Results-driven Drug Safety Scientist with over 10 years of progressive experience in pharmacovigilance and drug safety operations across leading organizations including Qinecsa, Bioclinica, and APCER Lifesciences. Demonstrated expertise in case processing, medical coding, safety narrative writing, quality review, and team mentoring. Highly skilled in global pharmacovigilance standards, E2B reporting, MedDRA, WHO-DD, and company product dictionaries. Proficient in multiple safety databases including Oracle Argus, ARISg, LifeSphere Multivigilance, and Sapphire, with a proven record of ensuring data integrity and regulatory compliance. Adept at managing Individual Case Safety Reports (ICSRs), mentoring cross-functional teams, and driving operational excellence. Recognized for analytical precision, leadership, and commitment to high-quality safety deliverables.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Drug Safety Scientist I
Qinecsa
04.2025 - Current
- Essential Duties and Responsibilities
Review and evaluate Adverse Event (AE) case information in accordance with internal policies, procedures, and regulatory requirements.
Process and prioritize incoming cases to ensure timely and accurate completion within established timelines.
Provide guidance and oversight to Data Entry and Quality teams, ensuring compliance with departmental workflow standards.
Conduct follow-ups with clinical sites to resolve outstanding queries and reconcile discrepancies.
Lead case reconciliation activities, including closure and deletion of cases as per project requirements.
Train, mentor, and supervise new team members and associates, fostering continuous learning and operational excellence.
Delegate tasks and responsibilities effectively, ensuring optimal resource utilization and project delivery.
Identify and resolve process issues and team conflicts, promoting a collaborative and productive work environment.
Serve as a coach and subject matter guide for Drug Safety and Senior Drug Safety Associates.
Maintain a high level of proficiency in all workflow activities and ensure adherence to standard AE workflow procedures.
Perform other pharmacovigilance and drug safety activities as assigned, demonstrating adaptability and commitment to quality.
Senior Drug Safety Associate
Qinecsa
03.2021 - 06.2022
- Key Responsibilities & Achievements
As Quality Check Reviewer
Reviewed and validated over 500+ safety cases monthly in global databases, ensuring 100% compliance with regulatory and internal quality standards.
Delivered detailed quality feedback that improved team accuracy scores by 15% within two quarters.
Monitored and analyzed key quality metrics (KQIs and KPIs), contributing to a 20% reduction in data entry errors and improved overall process efficiency.
As Case Processor
Processed and entered more than 2,000 Individual Case Safety Reports (ICSRs) with >98% accuracy and within agreed turnaround timelines (TATs).
Evaluated Adverse Event (AE) data and ensured adherence to E2B compliance and internal SOPs, achieving zero critical audit findings.
Performed comprehensive medical coding and safety narrative writing, improving case completeness and consistency across submissions.
As Medical Coder
Accurately coded 10,000+ data fields covering medical history, AEs, and medications using MedDRA, WHO-DD, and company dictionaries, ensuring consistent and regulatory-compliant terminology.
Enhanced data integrity by conducting spot-check audits that helped reduce coding discrepancies by 25%.
As Narrative Writer
Authored and reviewed 1,500+ medically sound and regulatory-compliant narratives, maintaining 100% audit compliance and ensuring clinical relevance.
Verified all data fields and narratives prior to final submission, resulting in zero case rejections during client and regulatory reviews.
Senior Drug Safety Associate
Bioclinica
03.2021 - 06.2022
- Key Responsibilities & Achievements – Data Entry
Performed accurate and timely data entry for over 2,000 Individual Case Safety Reports (ICSRs) into global safety databases, ensuring adherence to client timelines and regulatory standards.
Reviewed and validated Adverse Event (AE) case information for accuracy, completeness, and E2B compliance, maintaining an error rate below 2%.
Entered and coded case data, including medical history, adverse events, procedures, and laboratory results, using standard dictionaries such as MedDRA, WHO-DD, and company product dictionaries.
Coded and categorized suspect and concomitant products, ensuring consistency with reporter-provided data and internal conventions.
Authored medically relevant safety narratives that clearly captured case details, contributing to zero audit deviations in narrative quality reviews.
Conducted follow-up activities with sites and reporters to obtain additional or missing information, improving case completeness by 20%.
Initiated and managed Query Action Items (e.g., split case requests, data clarifications) to ensure timely case closure and database accuracy.
Generated and dispatched Non-Assessed License Partner Letters in accordance with regulatory and client requirements.
Identified and corrected data entry errors prior to case routing, ensuring 100% compliance with internal quality standards.
Implemented recommendations from quality reviews, contributing to improved workflow efficiency and case accuracy across the team. - Led cross-functional teams to enhance drug safety protocols, resulting in improved compliance and reduced safety incidents.
Senior Pharmacovigilance Associate
APCER Lifesciences
05.2015 - 03.2021
- Processed license partner, spontaneous, literature, and clinical trial cases in compliance with global regulatory standards and company SOPs.
Conducted quality review of Individual Case Safety Reports (ICSRs) in pharmacovigilance databases, maintaining a >98% accuracy rate across submissions.
Reviewed source data entered by data entry personnel; corrected discrepancies or routed cases back for revision, ensuring 100% data consistency and compliance.
Performed data entry and triage of ICSRs in accordance with project timelines and safety database workflows, contributing to on-time case closure for all deliverables.
Maintained up-to-date knowledge of evolving pharmacovigilance regulations and global reporting standards, ensuring continuous compliance with E2B(R3) and GVP guidelines.
Built and sustained collaborative relationships with cross-functional teams, client partners, and global affiliates to streamline communication and workflow efficiency.
Ensured strict adherence to project guidelines and audit standards, contributing to successful internal and external audit outcomes with no major findings.
Trained and mentored new employees in pharmacovigilance processes, improving team productivity and knowledge retention.
Performed administrative and documentation activities essential for project execution, maintaining accurate records and process compliance.
Education
M. Pharma -
Amity University
Noida, UPB. Pharma - undefined
JUIT
Solan, HPSkills
Adverse event review
Certification
May-2015 Registered Pharmacist Delhi Pharmacy council of India, Delhi
Disclaimer
Attestation: I confirm the information provided is accurate and complete when signed/email approved. Signature and date: Ilma Kauser 2025-10-31 Email approved date if applicable: 2025-10-31
JOB DESCRIPTION
- Essential Duties and Responsibilities:
- Review and evaluate AE case information to determine required action based on and following internal policies and procedures.
- Process current incoming cases in order to meet timelines.
- Provide guidance for Data entry & Quality teams.
- Following up with sites regarding outstanding queries.
- Follow-up on reconciliation discrepancies.
- Follow departmental AE workflow procedures.
- Train and mentor new team members as per requirements of the project.
- Delegate tasks and responsibilities to appropriate personnel
- Identify and resolve issues and conflicts within the project team
- Act as guide, coach and counselor for the team
- Following up with sites regarding outstanding queries and reconciliation of discrepancies
- Closure and deletion of cases
- Follow departmental AE workflow procedures
- Oversee, mentor and guide the activities of the Drug Safety and Senior Drug Safety Associates
- High level of proficiency at all workflow tasks
- Perform any other drug safety related activities as assigned
Timeline
Drug Safety Scientist I
Qinecsa
04.2025 - Current
Senior Drug Safety Associate
Qinecsa
03.2021 - 06.2022
Senior Drug Safety Associate
Bioclinica
03.2021 - 06.2022
Senior Pharmacovigilance Associate
APCER Lifesciences
05.2015 - 03.2021
B. Pharma - undefined
JUIT
M. Pharma -
Amity University