Divya Watti

• Led regulatory submission activities across a diverse product portfolio, ensuring timely and compliant reporting to health authorities.
• Served as a subject matter expert for FDA MedWatch submissions and Medical Device Reporting (MDR) requirements, providing guidance on submission-related activities and compliance expectations.
• Supported regulatory inspections, audits, and compliance assessments by providing documentation, submission records, and process-related information.
• Conducted quality reviews and compliance monitoring activities to ensure adherence to regulatory requirements, client expectations, and internal quality standards.
• Delivered process trainings, onboarding sessions, and knowledge-sharing initiatives to support team capability development and operational excellence.
• Managed client communications and submission-related queries, facilitating effective resolution of issues and ensuring alignment with reporting requirements.
• Supported new client onboarding activities, including process setup, requirement gathering, workflow alignment, and pharmacovigilance operational support.
• Contributed to safety database migration projects and supported the development, review, and validation of technical specifications and client deliverables to ensure successful implementation and business continuity.

• Selected by management to provide interim Project Manager support during a critical leadership transition, ensuring uninterrupted project operations, client engagement, and regulatory submission activities.
• Coordinated ICSR-related communications between clients and internal teams to facilitate timely query resolution.
• Managed end-to-end regulatory submission activities, ensuring timely and compliant reporting to regulatory authorities in accordance with applicable regulations and client requirements.
• Performed case assessment, data review, narrative evaluation, and reportability determination for adverse event and medical device cases.
• Prepared, reviewed, and submitted submission reports and Medical Device Reports (MDRs) across a diverse product portfolio to respective Health Authority
• Conducted quality checks of submission packages to ensure accuracy, completeness, and compliance with regulatory requirements.
• Collaborated with clients and global stakeholders to resolve case-related queries, obtain clarifications, and support submission readiness.
• Monitored submission timelines and compliance metrics to ensure adherence to regulatory reporting obligations.
• Supported follow-up activities, case reconciliation, and review of source documents, including medical records and product complaint information.
• Contributed to process improvement initiatives aimed at enhancing submission efficiency, quality, and regulatory compliance.
• Assisted in onboarding new products and reporting requirements by supporting process documentation and knowledge transfer activities.
• Worked closely with cross-functional teams to ensure successful execution of pharmacovigilance and medical device vigilance activities.

Performed triage and end-to-end processing of adverse event reports in the ARISg safety database across spontaneous, solicited, post-marketing, and clinical study sources. Supported reconciliation and quality activities while ensuring compliance with regulatory requirements and project timelines.

Worked as a Local Safety Officer (LSO) for solicited cases within the ARISg (AgXchange) safety database, performing case intake, triage, validity and seriousness assessment, duplicate searches, case creation, and initial data entry. Independently evaluated adverse events for reportability, coordinated with report sources to resolve discrepancies, and ensured accurate and timely case processing in compliance with client and regulatory requirements. Supported quality initiatives and mentored new associates.

Performed safety data entry and case processing activities within a client-specific pharmacovigilance database, ensuring compliance with SOPs, regulatory requirements, and quality standards. Selected within six months to support a pilot legacy case migration project and received the Sciformix Manager's Administration Reward for Talent (SMART) in recognition of outstanding performance and contribution.