DIVYA WATTI

Job responsibilities –

As a Quality Reviewer, Case processor and Case intake and Triager:

• Collection of Adverse Events (AEs) from all sources, tracking of cases through case processing activities, and coordinating workflow activities to promote accurate reporting and efficient time management as a Quality Reviewer
• Organize and track internal and Client feedback triage notification trackers for team reference and ensure they are addressed (designated POC)
• Communicated with internal or external contacts to resolve issues related to Case processing, Quality, Submissions, follow-ups, etc. as a client communication, email, and Query management POC.
• Interact with Manager and PV leads (Pharmacovigilance Operations) to discuss the ongoing project and maintain workflow and timelines.
• Facilitator in the Onboarding of new clients and the development of client documents such as standard operating procedures (SOP) and work instructions (WI) and met technical requirements.
• Leveraged ARIS-Global and affiliate and client-specific databases to enter and process patient data with accuracy.
• Incorporated varying medical philosophies and idiosyncrasies of health care delivery to generate global reports.
• Gather and evaluate quality challenge data to identify issues and improve process efficiency on project calls.
• Lead team members, e.g., Drug Safety Coordinators, Drug Safety Associates, to facilitate efficient case processing.

As an interim Submission specialist:

• Prioritize report deliverables to accomplish work within established timeframes.
• Ensure regulatory compliance with timelines for individual expedited case report submissions.
• Understand applicable corporate and global regulations, guidelines, SOPs, and writing practices.
• Works closely with PV Management to facilitate and meet client project deadlines.
• Independently formulate follow-up queries.
• Address any quality issues with the client.

As an Interim Process trainer/facilitator

• Facilitated onboarding training for new associates in all aspects of case handling and adverse event reporting, maintaining comprehensive training documentation.
• Conducted training for associates on Standard Operating Procedures (SOP), Work Instructions (WI), and guidance documents associated with safety management.
• Organized and conducted refresher training sessions, updating and maintaining training records for all associates.

As a client communication and query management POC:

• Engaged in client communications, addressing operational deliverables with clear and effective verbal and written skills.
• Helped in solving queries and facilitated resolutions, demonstrating adaptability and innovative problem- solving.
• Led as a facilitator of communication amongst an 10-member pharmacovigilance team and client.

• Worked in ARISg database (Triage and Case processing Activity)
• Handling of ICSR from solicited and unsolicited sources; Spontaneous reports; Clinical Study cases; Post-Marketing Surveillance reports
• Performed additional tasks/activities (e.g route cause analysis, reconciliation of the cases, and reviewing of the case narratives) as and when needed
• Update and document daily case data and follow-up trackers to facilitate tracking and workflow management
• Implement and promote use of consistent, efficient and quality process to meet timeline
• Ensure compliance with the operation
• Utilize expertise in safety systems to investigate status of reports and perform database queries for reconciliation purposes.
• Participating in quality huddles and meetings

• Worked in Case intake process as Local Safety Officer (LSO) for solicited cases in ARISg (AgXchange) database
• Responsibilities included: Case intake and triage, assessment of validity and seriousness, prioritization, duplicate searches, case creation (initial/follow-up), minimum data entry, clarification with the report source for discrepancies over call/emails
• Independent triage of AEs to determine reportability, including accurate data entry in the client safety database with minimal supervision
• Perform active follow-up via telephone contact with consumers and health care professionals for the client projects.
• Participated in trainings and quality-finding meetings
• Mentoring new associates
• Devoted special emphasis to punctuality and worked to maintain an outstanding attendance record, consistently arriving at work ready to start immediately.
• Worked flexible hours; night, weekend, and holiday shifts.
• Carried out day-to-day duties accurately and efficiently.
• Exceeded goals through effective task prioritization and a great work ethic.

• Worked in client-specific database for data entry/case processing activity
• Quickly learned new skills and applied them to daily tasks, improving efficiency, quality, and productivity.
• Performed duties in accordance with all applicable standards, conventions, SOP's and regulatory guidelines to promote quality cases submission
• Hand-picked for legacy cases data migration team (a pilot project) within 6 months tenure and awarded a Sciformix Manager's Administration Reward for Talent (Sep-2028) for excelling in the project