Rekha G Rao

Signal Detection and Management:

• Responsible for comprehensive signal detection activities for Teva products within the LSSRM framework, including active participation in literature review to identify ICSRs, PSURs, and new safety information for aggregate reporting.
• Detection of Statistical alerts including DME alerts.
• Authored signal evaluation reports and contributed sections as required.
• Maintained and developed expertise in assigned Teva products and therapeutic areas.
• Collaborated extensively with internal and external Teva Pharmacovigilance teams, including the Medical Scientific Unit.
• Mentored and provided training to new and existing team members.
• Ensured adherence to ICH, GCP guidelines, and company SOPs, implementing efficient processes to meet timelines.

Local Safety Officer (LSO) - Singapore & APAC Markets:

• Functioned as the Local Safety Officer for key APAC countries (Indonesia, Malaysia, Singapore, Thailand, Vietnam) and served as a backup LSO for Australia and New Zealand.
• Oversaw the complete lifecycle of safety information, including collection, documentation, triage, timely database entry, diligent follow-up, reconciliation, and maintenance of AE reports, ensuring submission to local authorities per regulatory requirements.
• Supported the establishment and ongoing maintenance of Teva's PV system across Singapore and APAC, including aiding in periodic report submissions (e.g., PSURs) and managing PV-related documentation (PV Agreements, PSURs, CCSI updates) in TrackWise.
• Negotiated and coordinated PV activities with internal and external stakeholders, including local distributors, to establish and rigorously follow PV Agreements, conducting periodic reconciliation per global and regional SOPs.
• Delivered essential PV training to internal Teva employees and external third parties.
• Collaborated with local regulatory affairs on safety labeling changes and identified Significant Safety Issues (SSI) or Other Safety Issues (OSI) from various sources.
• Actively supported local and regional PV audits and inspections, including readiness activities and the development/execution of CAPAs.
• Maintained and assessed SSI (Safety Signal Identification) / OSI (Ongoing Safety Issue) trackers.
• Conducted thorough assessments of SSI and OSIs.
• Tracked weekly regulatory intelligence notifications.
• Ensured timely and compliant reporting of OSIs to MedSafe and the TGA.

CCSI Coordinator & Maintenance:

• Managed Company Core Safety Information (CCSI) coordination and maintenance, ensuring accurate and timely dissemination of safety updates.
• Maintained TrackWise records for CCSI.
• Prepared and distributed safety notification letters to the local Regulatory Affairs (RA) team, meticulously comparing PI/PIL with innovator PI and company CCSI.
• Facilitated submission of safety notification letters to Health Authorities upon RA team confirmation.
• Liaised with RA and Global CCSI teams to resolve discrepancies.
• Collaborated with the compliance department to establish monitoring standards.

Case Management & Medical Evaluation:

• Focused on comprehensive pharmacovigilance case management, including medical evaluation and compliance, with expertise in pregnancy case processing.
• Performed medical evaluation of serious and non-serious adverse events from clinical trials (SAEs, AESI) and post-marketing sources, ensuring accurate MedDRA coding in ArisG.
• Conducted data verification between source documents and ArisG for accurate event evaluation (e.g., seriousness, causality, listedness, narrative writing), assessing the need for follow-ups and queries with stakeholders.
• Served as the Pregnancy Manual SME, leading RMP case processing design for pregnancy cases.
• Mentored and trained team members, including new hires, in case processing and knowledge transfer.
• Provided administrative support for daily case processing, coordinated with stakeholders for information, and ensured compliance with work instructions and GVP modules.
• Ensured case processing quality, identified trends for process improvement, met compliance metrics (e.g., case timelines, training, TAT), and provided analytical support for investigations, audits, and inspections.

• Managed end-to-end ICSR processing, including data receipt, review, meticulous data entry, medical coding, narrative writing, query generation, quality review, reconciliation, and case closure, adhering strictly to timelines.
• Addressed stakeholder emails supporting ICSR activities and clarified information with CRAs and clinical teams.
• Assisted operations, acted as a backup, and contributed to status reports, productivity, and utilization metrics.
• Performed and managed safety information collection, documentation, triage, and AE report creation/maintenance.
• Executed weekly, monthly, and yearly archival activities (I-etmf, Wingspan) and resolved database lock queries.
• Contributed to innovation and process improvements and trained new hires in case processing and quality review.
• Attended project meetings to provide feedback and liaised with clients on daily case processes.
• Collaborated with management to achieve departmental goals.

• Conducted academic research in pharmaceutical and medicinal chemistry.
• Assisted with drug discovery and development experiments.
• Contributed and published research articles under the guidance of senior scientists.