Krithika Mohan
Vandalur
Summary
Experienced Drug Safety Associate with over 4 years of experience. Accomplished Drug Safety Associate with a proven track record at Accenture, adept in case processing and fostering a culture of quality. Skilled in utilizing the Argus database and mentoring staff, I significantly reduced reporting errors, enhancing safety data accuracy. Expert in regulatory authority cases and committed to continuous improvement in pharmacovigilance.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Drug Safety Associate
Accenture
Chennai
03.2022 - Current
- Perform case creation for spontaneous, clinical (Interventional studies, non-interventional studies), E2b, LM, and literature cases.
Review and self QC all forms and documents pertaining to a case: duplicate, irrelevant information, legibility, redaction, and splitting of documents; and request for rescanning/splitting if required. - Review all data entered in the ICSR, and add missing information based on the source documents.
- Conducted thorough quality control reviews of adverse event reports to ensure compliance with regulatory standards and internal protocols.
Analyzed pharmacovigilance data to identify trends, discrepancies, and areas for improvement in safety reporting processes.
Trained and mentored junior staff on quality control practices and pharmacovigilance regulations, fostering a culture of quality and safety.
Improved the accuracy of safety data reporting by implementing a new QC checklist, reducing reporting errors.
Follow up with clients regarding outstanding queries and reconciliation of discrepancies.
Drug Safety Associate
IQVIA
Kochi
01.2021 - 02.2022
- Review and process data from various sources: perform intake, triage, data entry, coding relevant medical terminology, writing descriptive narratives, performing follow-up with reporters. Performed ICSR processing and reporting of safety information, including data entry of safety information, initial determination of seriousness, and determining follow-up activities, which can be spontaneous regulatory authority cases.
Ensure accurate indications using a medical dictionary, such as MedDRA. - Confirm case validity, event term selection, and coding.
- Assess Lifecycle Safety data for reportability to relevant authorities and report to regulatory authorities within timelines and in a format compatible with requirements.
Ensure to meet quality standards, per project requirements. Identify quality problems, if any, and bring them to the attention of a senior team member.
Ensure to meet productivity and delivery standards per project requirements. Attend project team meetings and provide feedback to the operations manager on any challenges/issues or successes.
Education
Master of Science - Applied Microbiology
Ethiraj College for Women
Chennai01.2020
Bachelor of Science - Microbiology
Annai Violet arts and science college
Chennai01.2017
HSC -
L.E.F Eden Matric.Hr. Sec.School
01.2014
SSLC -
L.E.F Eden Matric.Hr. Sec.School
01.2012
Skills
- Strong Interpersonal Skills
- Workplace Efficiency
- Proactive Self-Starter
- Adaptability and Reliability
Certification
- DMLT (Diploma in Medical Lab Technician)
- Advanced Certification in Medical Coding
- Diagnosis Coding - ICD 10 CM General and Chapter Specific Guidelines
- Procedure Coding - CPT & HCPCS Coding
- Revenue Cycle Management: Medical Coding & Billing Cycle
- HIPAA Compliance
Extracurricular Activities
Staged Dramas and Cultural activities at college Music Listening
Languages
English, Tamil, English, Tamil
Internshipandworkshop
- Attended workshop cum seminar on Recent advance in Biological Research Data Analysis in Ethiraj College for Women in collaboration with Presidency College.
- Attended International Conference - MICRO SUMMIT 2019 in Saveetha Dental College.
- Attended Internship Training on Emerging Trends in Bio Research Techniques in Meenakshi Ammal Dental College and Hospital.
- Attended Internship training in United Breweries Limited.
Languages
Tamil
First Language
English
Advanced (C1)
C1
Timeline
Drug Safety Associate
Accenture
03.2022 - Current
Drug Safety Associate
IQVIA
01.2021 - 02.2022
Master of Science - Applied Microbiology
Ethiraj College for Women
Bachelor of Science - Microbiology
Annai Violet arts and science college
HSC -
L.E.F Eden Matric.Hr. Sec.School
SSLC -
L.E.F Eden Matric.Hr. Sec.School
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