Poojitha Kakarla
Hyderabad
Summary
Seasoned Pharmacovigilance professional with over 14 years of experience leading drug safety operations across clinical trials (including patient support programs, compassionate and investigator-initiated) and post-marketing environments (including spontaneous, literature). Proven expertise in ICSR case processing and automation in Pharmacovigilance.
Recognized consistently for performance excellence and contributions to team success through hard work, attention to detail and excellent organizational skills. Clear understanding of assigned tasks training. Motivated to learn, grow and excel in Pharmacovigilance. Excellent reputation for resolving problems and improving customer satisfaction.
Overview
4
4
Languages
14
14
years of professional experience
Work History
Associate Manager, Pharmacovigilance (PV) Operatio
Parexel international Pvt Ltd
Hyderabad
03.2022 - Current
- Managed 20-member PV case processing team, supporting PDPs, appraisals, timesheet approvals, and team morale.
- Maintained 99.5% compliance across expedited and non-expedited ICSRs in line with FDA, EMA, and ICH guidelines.
- Tracked daily WIP, cleared backlogs, and removed bottlenecks to keep case processing on schedule.
- Led cross-functional root-cause reviews for quality deviations, drafted CAPAs, and updated department SOPs.
- Spearhead process improvement initiatives that increased case processing throughput and reduced backlogs through enhanced workflow allocation and daily reconciliation.
- Served as main contact for internal and external audits and client safety governance meetings, presenting KPI dashboards and quality metrics.
- Contributed to automation of intake and case processing activities, reducing manual effort by 30%.
- Reviewed direct reports' quality, giving feedback and coaching that improved quality scores.
- Coordinated project and client-specific training, preparing team members for new projects.
- Planned daily leave and shift coverage to keep operations running and case timelines on track.
- Managed onboarding tasks, including system access, documentation, and induction, plus offboarding tasks, including access removal, work handover, and documentation.
- Supported mentors training new joiners, helping keep mentoring quality consistent and ramp-ups smooth.
- Led case correction and workflow spot-check QC, then applied corrective actions from findings.
- Analyzed recurring error trends and root causes, then delivered refresher training on frequent error types to reduce repeat errors.
- Planned and delivered training on major and minor process updates, helping team apply changes correctly.
- Verified team understanding of process changes through assessments, feedback, and QC results.
- Contributed to automation of intake and case processing activities, reducing manual effort by 30%.
- Identified manual process inefficiencies and suggested workflow improvements.
- Supported adoption of automated workflows and tools by training team members on usage.
- Reviewed study budgets and expenses to track costs against approved budget.
DRUG SAFETY SPECIALIST/SENIOR DRUG SAFETY SPECIALI
Parexel international pvt Ltd
Hyderabad
11.2016 - 02.2022
- Processed and reviewed ICSRs from clinical trials, PMS studies, and postmarketing sources with >99% quality accuracy.
- Facilitated signal detection by reviewing safety data, identifying trends, and escalating potential risks.
- Handled reporting and submission of ICSRs for registered products to EU authorities and licensing partners.
- Provided medical review support for PBRER, PSUR, DSUR listings, and safety updates for medical officers.
- Ensured quality and timely deliverables for ICSR processing.
- Assisted in preparing for pharmacovigilance audits by ensuring documentation was organized and accessible. and inspection preparation while helping maintain zero critical findings.
- Supported EDC data management by monitoring errors noted, event removals, and added event versions through close coordination with data management team to meet database lock (DBL) timelines.
- Drafted SPPS, DEG documents, and query templates to improve case handling efficiency.
- Proposed workflow improvements that minimized delays.
- Worked with client and team leadership to keep projects on time and within budget.
- Provided pharmacovigilance quality and compliance training to associate and specialist staff.
Drug Safety Associate
Parexel international Pvt Ltd.
Hyderabad
11.2013 - 11.2016
- Supported initial triage, data entry, assessment, and narrative writing for global ICSR cases.
- Processed individual case safety reports from literature, signals, regulatory information, and other sources, supporting aggregate and study report preparation and product dictionary updates.
- Completed seriousness, causality, and expectedness assessments with accuracy.
- Performed written and telephone follow-ups to collect complete case information.
- Conducted compliance tasks, including quality review of deliverables, metric generation, and investigations of late deliverables under international and local reporting requirements.
- Assisted medical directors with medical monitoring tasks, including reviewing endpoint packages, assessing laboratory alerts, evaluating eligibility, and reviewing protocol deviations.
- Assigned tasks to assistants to maintain project workflow. to assistants and maintained study documentation, case report files, and tracking files.
- Participated in client meetings and project-specific training sessions.
Regulatory Affairs Contractor
Novartis
Hyderabad
05.2012 - 10.2013
- Submitted and filed dossiers, certificates, batch records, and other regulatory deliverables.
- Worked with regulatory CMC on process changes, production transfers, and first-time registrations.
- Tracked registration samples and related documentation in coordination with global CPOs and stakeholders.
- Gathered regulatory documents for marketing authorization maintenance to support ROW markets.
Education
Master of Science - Pharmaceutical Analysis
SASTRA University
Thanjavur09-2012
Bachelor of Science - Pharmacy
Kakatiya University
Khammam06-2010
Skills
- Pharmacovigilance case processing
- ICSR processing
- Signal detection
- Safety database management
- Clinical database expertise
- Veeva vault
- Other tools: ARCQ, PV Analytics, Power BI, MS Suite
- Team management
Languages
English
Proficient (C2)
C2
Hindi
Intermediate (B1)
B1
Telugu
Native
Native
Tamil
Beginner
A1
Timeline
Associate Manager, Pharmacovigilance (PV) Operatio
Parexel international Pvt Ltd
03.2022 - Current
DRUG SAFETY SPECIALIST/SENIOR DRUG SAFETY SPECIALI
Parexel international pvt Ltd
11.2016 - 02.2022
Drug Safety Associate
Parexel international Pvt Ltd.
11.2013 - 11.2016
Regulatory Affairs Contractor
Novartis
05.2012 - 10.2013
Master of Science - Pharmaceutical Analysis
SASTRA University
Bachelor of Science - Pharmacy
Kakatiya University