Komal Panarvala

Medical Information & Pharmacovigilance Leader with 16+ years of experience across global pharma, biotech and brand pharma. Experienced in specialty medicine, biologics, hematology-oncology, autoimmune conditions, and other complex therapeutic areas that require deep scientific understanding similar to rare disease medical information. Expertise in complex case handling, developing high-quality and balanced MI responses, leading MI operations, and supporting scientific accuracy review of promotional and non-promotional materials.

Skilled in literature evaluation, pathophysiology and pharmacotherapy interpretation, cross-functional collaboration, and vendor and PV/MI call centre oversight. Strong competency in AI-enabled literature review, content generation, and quality evaluation of AI outputs. Led successful Health Canada inspection readiness with zero observations in PV (2023), demonstrating strong compliance, documentation quality, and operational governance.

Built and led end-to-end MI/PV operations, including inquiry management, scientific response development, standard response letters, FAQs, clinical summaries, training materials, other medical/scientific communications. Supported MI/PV booth activities during internal and external Galderma medical meetings, ensuring accurate scientific communication and stakeholder engagement. Strong background in statistical analysis, workflow optimization, automation, and driving operational excellence initiatives.

Detail-oriented, compliance-driven, analytical, collaborative, and deadline-focused, with strong people leadership, project management, and communication skills.

Manager, Pharmacovigilance (PV) & Medical Information (MI) - Galderma Canada - Thornhill ON

(2022-02 - 2024-11)

Led end-to-end MI/PV operations, serving as LSO and ensuring timely, accurate, balanced, scientifically rigorous, and compliant responses to HCP, patient, caregiver, and internal inquiries. Established MI/PV function from ground-up; developed, maintained, and updated PV/MI SOPs/Wis, gap assessments, and governance processes; supported operational improvements and system enhancements.

• Managed MI intake, triage, escalation, and complex inquiries; developed 300+ SRDs/SRLs annually, reducing MI response time by 70% through development of a customized MI repository and workflow automation
• Conducted advanced literature searches and clinical evidence evaluation to develop and maintain MI responses, FAQs, clinical summaries, product knowledge resources, and scientific content, ensuring scientific accuracy, appropriate references, and alignment with approved product information
• Applied AI tools, including Microsoft Copilot, to support Medical Information activities such as literature review, information synthesis, content development, and summarization; critically evaluated and verified AI-generated outputs against scientific evidence and approved sources to ensure accuracy, appropriate medical context, compliance, confidentiality, and quality
• Supported the Alastin acquisition and integration, contributing to MI readiness, product knowledge transfer, content development/maintenance, and cross-functional activities associated with the transition and integration of the acquired portfolio
• Supported new product launches and launch-readiness activities, partnering cross-functionally to ensure MI resources, scientific content, training, and operational processes were prepared for commercialization
• Reviewed promotional and non-promotional materials through MLR/scientific review committees, assessing scientific accuracy, evidence, claims substantiation, fair balance, and appropriateness of references
• Developed and reviewed medical affairs and scientific communications, including disease-state content, scientific narratives, slide decks, training materials, FAQs, clinical summaries, and internal medical resources
• Leveraged MI repositories, LSMI, Veeva MedComms/PromoMats and other digital tools to support medical content lifecycle management, inquiry response processes, content governance, and operational efficiency
• Conducted and supported quality review, case review, reconciliation, documentation, KPI monitoring, and trend analysis, using inquiry and operational data to identify insights and opportunities for process improvement
• Developed and delivered MI/PV training to 200+ stakeholders, including internal cross-functional teams, and represented MI/PV in global, Canadian, and external scientific meetings
• Supported MI/PV booth activities during internal and external Galderma medical meetings, ensuring accurate scientific communication and stakeholder engagement
• Partnered with Global Safety, Medical Affairs, Regulatory, Commercial, QA, and Legal to address medical inquiries, safety issues, product changes, regulatory requirements, and cross-functional MI needs
• Supported AE and product-quality complaint processes for drugs, medical devices, and cosmetics, ensuring appropriate assessment, documentation, escalation, and reporting in accordance with Health Canada/GVP/ICH requirements
• Served as SPOC/SME for audits and inspections, managing inspection readiness, RCA/CAPA activities, documentation and version control; successfully supported a Health Canada medical device inspection with zero PV observations (2023)
• Managed the annual PV/MI budget and resource allocation, prioritizing operational needs and supporting efficient delivery of MI and PV activities

Drug Safety Officer/ Pharmacovigilance Associate II - Teva Canada - Scarborough ON

(2017-03 - 2022-02)

Supported MI and PV operations by identifying AEs and product complaints during inquiry handling of solicited and unsolicited reports.

• Processed and quality-reviewed ICSRs, ensuring timely submission to Health Canada and global authorities
• Performed medical review, reconciliation, and database entry to maintain data integrity
• Conducted literature/database screening and supported signal detection activities
• Contributed to ASR/PSURs and aggregate safety reporting
• Maintained SOPs, implemented CAPAs, and supported PV system improvements
• Participated in regulatory audits and inspection readiness activities; delivered PV training to new and existing staff

Business Process Lead - Tata Consultancy Services (TCS) - Pune, India

(2012-06 - 2017-01)

Worked for USA based biopharmaceutical company Amgen's life science project for pharmacovigilance. Managed comprehensive case processing activities for Amgen safety reports, including intake, triage, data evaluation, narrative development, coding, medical review, and quality review.

• Led PV operations and served as SME across programs, ensuring compliance with global regulatory requirements and internal quality standards
• Served as a SPOC/SME for hematology-oncology project; supported client engagement; project delivery, and project acquisition
• Conducted quality reviews, KPI monitoring, reconciliations, and RCA/CAPA governance to strengthen operational consistency and compliance
• Supported audits and process improvements; ensured adherence to regulatory timelines and documentation accuracy
• Delivered PV onboarding and process training, strengthening operational capability and consistency
• Worked within a high-volume CRO environment, managing strict timelines, complex workflows, and evolving client requirements

Executive - Drug Safety and Epidemiology - Novartis India Limited - Mumbai, India

(2010-12 - 2011-09)

Assessed, triaged, and processed clinical trials, spontaneous, post-market safety reports.