Mounica Choudari Daruvuri
Bengaluru
Summary
Pharmacovigilance team leader with extensive experience at Cognizant and Accenture Solutions, specializing in quality management and compliance. Proficient in ICSR processing and RCA/CAPA implementation, resulting in notable efficiency gains. Skilled in mentoring teams and improving client communication, ensuring timely regulatory submissions and audit readiness. Resilient and adaptable, consistently maintaining current knowledge to facilitate a successful workforce reintegration.
Overview
1
1
Certification
14
14
years of professional experience
Work History
Career Break
05.2022 - Current
- International relocation, maternity, and early childcare.
- Remained updated on pharmacovigilance regulations, ICSR processing standards, and quality trends.
- Fully available for workforce re-entry.
Team Lead - Pharmacovigilance Quality
Cognizant Technology Solutions
06.2021 - 04.2022
- Directed comprehensive PV quality operations and workload distribution across four delivery sites.
- Conduct in-line quality review of ICSRs to ensure accuracy, completeness, and compliance with regulatory requirements and company conventions.
- Identify and escalate any discrepancies and quality issues observed during the review process.
- Provide guidance and support to the case processing team on quality-related matters.
- Tracked internal and external case-quality findings and published regular quality metrics at associate and team-lead levels.
- Managed client escalations by providing timely, data-driven responses supported by impact assessment and root cause analysis.
- Reviewed correction cases, identified root causes, and implemented corrective and preventive actions to strengthen process quality.
- Conducted quality huddles to address new scenarios, recurring errors, and oversight gaps while ensuring SLA, KPI, and quality compliance.
- Monitored process adherence and reinforced compliance with internal procedures, external requirements, and applicable work standards.
- Ensured completion of mandatory trainings and maintained accurate training compliance records and supporting documentation.
- Set team performance goals and provided regular coaching, feedback, and guidance to improve productivity and quality.
- Conducted annual performance appraisals for direct reports and implemented development action plans for underperforming team members.
- Managed quality deviations and implemented action plans to prevent recurrence.
- Tracked and shared offline quality check outcomes for non-serious and incomplete report cases.
- Led weekly governance calls with Team Leads to review quality trends, case corrections, corrective actions, and performance targets.
- Develop and maintain quality metrics and reports to track performance and identify areas for improvement.
- Stay updated on relevant regulations and guidelines related to PV.
- Participate in internal audits as needed and ensure timely resolution of any findings related to ICSR quality.
- Created a CAPA tracker for the recurring errors, driving structured RCA review, action plan tracking, and proactive monitoring of error trends.
- Published weekly quality scorecards while monitoring KPIs to drive performance improvements.
- Conducted trend and Pareto analysis, authored RCA/CAPA, and ensured timely resolution of issues.
- Maintained audit readiness and upheld compliance with standard operating procedures.
- Managed client communications, addressing escalations and submitting CAPA evidence promptly.
Medical Review Advisory - Senior Analyst (Team Lead)
Accenture Solutions Pvt. Ltd.
03.2020 - 02.2021
- Led team delivery for quality and productivity targets.
- Drove efficiency improvements through identification and resolution of process gaps.
- Supported client audits and CAPA implementation.
- Partnered closely with clients to manage end-to-end SUSAR case completion and ensure on time expedited submissions to health authorities.
- Hands-on experience working with Argus safety databases for case processing, quality review, and submission.
- Conducted quality huddles to address new scenarios, operational challenges, correction trends, and quality check expectations.
Expedited Safety Reporting Scientist
Accenture Solutions Pvt. Ltd.
04.2019 - 02.2020
- QC of expedited and non-expedited ICSRs including SUSARs.
- Ensured compliance with IBs, product labels, and regulatory timelines.
- Mentored new hires and supported quality improvement initiatives.
- Participated in client meetings, case review discussions and resolving discrepancies.
Medical Services Senior Analyst
Accenture Solutions Pvt. Ltd.
04.2014 - 04.2019
- Processed and reviewed ICSRs across multiple therapeutic areas.
- Conducted quality huddles to address new scenarios, operational challenges, correction trends, and quality check expectations.
- Ensured accurate and consistent coding of adverse events and medical terms using MedDRA coding.
- Performed a listedness assessment by comparing reported events against RSI, CCDS, and IB.
- Collaborated with medical reviewers and case processors to resolve complex coding queries.
- Acted as a Quality SME, and supported peer reviews and safety meetings.
- Prepared high-quality case narratives that were chronologically structured and aligned with source documents, ensuring regulatory compliance.
Junior Executive - Pharmacology
SPi Technologies (Elsevier)
07.2012 - 04.2014
- Reviewed and submitted preclinical safety and toxicology data.
- Abstracted and indexed biomedical literature for REAXYS and EMBASE databases.
- Extracted pharmacology data from journals and patents.
Education
M.Pharm - Pharmacology
St. John's Pharmacy College
BangaloreB.Pharm -
Sree Vidyanikethan College of Pharmacy
TirupatiSkills
- Pharmacovigilance Quality Management
- ICSR Processing & QC Review
- Expedited reporting (7/15 days)
- GVP and regulatory compliance
- MedDRA Coding
- RCA/CAPA & Trend Analysis
- Quality Metrics & KPIs
- Audit Readiness
- ARGUS Safety Database
- Team Leadership
- Aggregate reporting
- Signal detection
- Client Communication
- Basic SAS Programming
Certification
- SAS Certification (DATA step, PROC SORT, MEANS, FREQ, SUMMARY)
- ARGUS Proficiency Certified
Accomplishments
- Multiple Star of Business and Spot Awards for quality excellence.
- Recognized for high productivity and error-free delivery.
- Appreciated for team retention and motivation during high-attrition periods.
Custom
https://linkedin.com/in/mounica-choudari-daruvuri-6a14051b5/
Timeline
Career Break
05.2022 - Current
Team Lead - Pharmacovigilance Quality
Cognizant Technology Solutions
06.2021 - 04.2022
Medical Review Advisory - Senior Analyst (Team Lead)
Accenture Solutions Pvt. Ltd.
03.2020 - 02.2021
Expedited Safety Reporting Scientist
Accenture Solutions Pvt. Ltd.
04.2019 - 02.2020
Medical Services Senior Analyst
Accenture Solutions Pvt. Ltd.
04.2014 - 04.2019
Junior Executive - Pharmacology
SPi Technologies (Elsevier)
07.2012 - 04.2014
M.Pharm - Pharmacology
St. John's Pharmacy College
B.Pharm -
Sree Vidyanikethan College of Pharmacy