Pallavi Jindal

Experienced Pharmacovigilance personnel with over 9 years of expertise in Individual Case Safety Report (ICSR) processing and end-to-end case management. Proficient in triage, data entry, quality analysis, MedDRA/WHO-DD coding, narrative writing, and regulatory submissions across global markets. Demonstrates excellent interpersonal and communication skills with a proven ability to collaborate effectively across cross-functional teams, liaise with regulatory authorities, and mentor junior colleagues. Highly adaptable, detail-oriented, and commitment to high-quality safety data.

• Participation in Standard operating procedure (SOP) and Work Instruction (WIN) Development and Quality Audits

• Regulatory Compliance Knowledge (ICH-GCP, E2E, EudraVigilance, FDA 21 CFR Part 11)

• Performed user error trend analysis, identifying root causes of recurring case processing issues and implementing targeted corrective actions that improved data accuracy and team quality.

• Strong Communication (verbal and written—especially for regulatory submissions)

• Team Collaboration and Cross-Functional Coordination

• Problem-Solving under Regulatory Pressure

• Time Management & Multitasking

• Data Analysis & Interpretation

• Root Cause Analysis

• Critical Thinking & Decision-Making

• Pharmacovigilance in Medical Devices or Vaccines

• Ability to work independently with minimal supervision and in team environment

• Adaptability to various databases as per client's requirement

• Performed comprehensive quality and validation checks of ICSRs, ensuring compliance with client SOPs, regulatory guidelines, and MedDRA coding standards.

• Performed end-of-line quality control (QC) of Individual Case Safety Reports (ICSRs) to ensure accuracy, medical consistency, and compliance with regulatory and client-specific standards pos the case closure and submission. Maintained the team Key performance Indicator (KPIs).

• Managed end-to-end processing of all ICSR types (spontaneous, solicited, clinical trials), including triage, registration, duplicate search, data entry, causality/seriousness assessment, and narrative writing.

• Coordinated case reconciliation with Data Management teams and addressed discrepancies through query resolution.

• Ensured accurate and timely case routing through workflow stages in the safety database and maintained consistency checks across source documentation.

• Collaborated with cross-functional client teams and supported preparation, participation, and follow-up for audits and inspections.

• Supervised reporting obligations, monitored compliance metrics, and maintained awareness of global and local regulatory requirements.

• Mentored new team members, delegated responsibilities to Drug Safety Assistants, and facilitated training sessions.

• Identified and escalated case processing or quality concerns to senior management, contributing to process enhancements.

• Demonstrated therapeutic area experience in oncology, dermatology, virology, autoimmune disorders, CNS, and cardiovascular diseases.

• Handled client tools for product lifecycle updates, including additions, withdrawals, and license expirations.

• Attend/Conduct internal, drug safety and project specific training sessions

• Preparation for, participation in, and follow up on audits and inspections

• Collect and review metrics for measuring reporting compliance

• Query management:

• Interacting with appropriate client personnel to resolve issues related to the processing of ICSRs in

• accordance with clients’ policies. Responding to clients/customers in a timely manner.

• Report nullification (decision making and processing) and case merging into a ‘Master’ case.

• Maintaining knowledge of the AE safety profile of assigned drugs, Reference Safety Information documents, data entry conventions and guidelines, clients’ procedures and international drug safety regulations including.

• Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting.

• Creates the case on the safety database and performs Data entry into safety database

• Performs clear and accurate data capture of cases in accordance with client conventions/guidelines and Standard Operating Procedures (SOPs)

• Awareness of ICH GCP and other clinical research/healthcare relevant guidelines.

Continuum India LLP

Position: Senior PV specialist

• Acted as the primary backup to the manager, providing leadership and oversight to team members to ensure operational continuity and performance excellence.

• Managed and maintained the product-specific issue log, including client-raised queries, updated product guidance, and Reference Safety Information (RSI) revisions, ensuring timely documentation and communication.

• Oversaw case distribution among team members, ensuring timely processing and consistent achievement of 100% compliance with reporting deadlines.

• Mentored and trained new recruits—both entry-level and experienced professionals—ensuring adherence to client-specific SOPs and work instructions (WINs); conducted annual instructor-led refresher sessions and facilitated Train-the-Trainer programs to build internal training capabilities.

• Managed group-specific mailbox, ensuring timely triage, assignment, and response coordination to support seamless team operations and effective client communication.

• Acted as subject matter expert (SME) for PV Quality and Compliance, driving audit readiness, CAPA management, and adherence to global regulatory standards. Led quality-driven process improvements and compliance training, earning internal recognition and nomination for the India Country Head Award.
• Functioned as SME in PV data entry, ensuring accurate, consistent, and compliant case processing across global safety databases. Provided guidance on data quality standards, supported onboarding of new team members, and contributed to optimizing workflows for enhanced efficiency and regulatory alignment.
• Effectively conveyed complex database functionalities and evolving processes to non-technical stakeholders by conducting client-specific Train-the-Trainer sessions, fostering knowledge transfer and operational efficiency.
• Contributed to automation initiatives by supporting the development of system-generated, significantly reducing manual effort and resource utilization.
• As part of the ARGUS transition (SSP testing), actively participated in database testing to validate user login/logout, application access, system performance under load and data transfer. Ensured secure access, smooth integration with connected systems, intuitive user experience, and effective error handling. Maintained clear communication to support users throughout the process.
• Recognized for excellence in empowerment, accountability, expertise, and collaboration, reinforcing commitment to high professional standards and team success.