Deputy Manager, Quality Reviewer — Aggregate Reports & Risk Management Plan at APCER Life Sciences (2025-12 – Present)
- Conducts quality review of PBRERs/PSURs, DSURs, CASRs, and PADER reports against source documents to ensure high-quality output.
- Management of regular activities and status across teams, and carries out administrative duties as required.
- Management roles involves leading client weekly/monthly status call, Audits/Inspections, reports assignment according to AR schedule and other activities.
- Authoring of PBRERs/PSURs, DSURs, CASRs, ADCOs, PADER and regional-specific reports.
- Authoring/Quality Review involves: Project coordination and stakeholder collaboration, including safety physicians for clinical rationale, statisticians and data managers for data inclusion and line listings, QPPV for report review, and Regulatory team for final submission and compliance.
- Scheduling and leading kick-off meetings to align on authoring strategy and approach.
- Reviewing and analyzing large volumes of source data, including line listings, signal assessments, and scientific literature, to identify safety trends, patterns, and newly emerging signals.
- Writing analyzed data into structured report format covering medication error, overdose, abuse, pregnancy, etc., including sales calculations and country-wise listings.
- Signal-risk evaluation, including risk characterization based on article search and inclusion of efficacy-related literature.
- Benefit-risk evaluation incorporating newly identified efficacy information and characterization of benefit, including medical need and alternative treatment context.
- Performs safety analysis of cases for inclusion in reports and drafts safety sections, collating issues from previous reports, HA assessments, and Medical Reviewer findings.
- Responsible for weekly status calls and maintaining the quality dashboard, ensuring RCA/CAPA for internal and external findings.
- Training and mentoring of new hires on aggregate report writing and related pharmacovigilance activities.
- Prepares and reviews Risk Management Plans per regulations and SOPs, including additional risk minimization measures (aRMM) and assessment reports.
- Prepares generic RMPs and updates them throughout the product lifecycle, ensuring consistency with other regulatory documents (PBRER/Clinical Overview, etc.).
- Participates in Health Authority regulatory responses related to RMPs and evaluates safety concerns for inclusion in safety specifications and pharmacovigilance activities (TFUQs/RMMs).
Manager, Safety Writing at Tata Consultancy Services (2022-07 – 2025-12)
- Planned, authored, and reviewed PSURs/PBRERs, DSURs, PADERs, and CASRs.
- Liaised and coordinated with stakeholders (Regulatory, Clinical, Labelling, and co-licensees) to collect data for safety reports.
- Detected and managed safety signals, issues, and new information impacting benefit-risk in line with the Safety Review Plan and Safety Surveillance Plan.
- Reviewed PRAC and other regulatory authorities' safety updates; prepared and reviewed query responses to Regulatory Authorities.
- Reviewed literature triaged within the Drug Safety Triager tool for signal detection and aggregate reporting, documenting assessments within the tool.
- Mentored trainees on process, supported team effectiveness, and actively participated in audits and inspections.
Assistant Manager / Business Process Lead at Tata Consultancy Services (2015-06 – 2022-06)
- Managed project workflow, capacity planning, and staffing to meet SLAs; handled client and internal stakeholder communication and compliance reporting (CAPA, RCA, trend analysis).
- Led quality management, audits/inspections readiness, and SOP/Job Aid maintenance; implemented process automation achieving 92% BOT efficiency and ran Agile sprints as scrum master.
- Drove continuous-improvement initiatives and special projects, contributing to cost savings and business growth for the organization.
Data Analyst at Cognizant Technology Solutions (2012-09 – 2015-05)
- Handled spontaneous and clinical trial ICSR case processing on ARISG and ARGUS, including data capture, clinical assessment, adverse event labelling, and safety narrative writing.
- Performed quality review of processed ICSRs and mentored new joiners on process.
Quality Analyst at GeBBS Health Care Solutions (2011-06 – 2012-09)
- Coded procedures and diagnoses (CPT, ICD-9-CM, HCPCS) across inpatient, outpatient, facility, and physician care for insurance reimbursement, and quality-checked coded reports.
