Sunil Nighot

Strategic Pharmacovigilance Quality & Governance leader with 15+ years of experience across multinational pharmaceutical and CRO environments, driving enterprise-level safety compliance across US, EU, and APAC markets. Proven track record supporting FDA and EMA inspections with zero critical findings while architecting scalable QMS frameworks, strengthening PSMF governance, optimizing vendor oversight models, and leading compliance-critical PV system migrations. Recognized for transforming pharmacovigilance operations through KPI-driven automation, regulatory risk mitigation, and cross-functional governance alignment.

Trusted partner to Global Safety, Regulatory Affairs, Clinical Development, IT/Validation, and Executive Leadership.

Pharmacovigilance Quality & Compliance Manager at Kenvue (formerly Johnson & Johnson) (2023-01 – 2025-08)

Directed PV Quality Management System (QMS), including deviation management, CAPA oversight, risk mitigation, and compliance monitoring. Supported multiple FDA, EMA, and global health authority inspections and audits with zero critical findings.

• Directed PV Quality Management System (QMS), including deviation management, CAPA oversight, risk mitigation, and compliance monitoring.
• Supported multiple FDA, EMA, and global health authority inspections and audits with zero critical findings.
• Governed PSMF lifecycle, ensuring alignment with EU GVP Module II requirements and inspection readiness standards.
• Led vendor governance model monitoring SLA adherence, compliance metrics, and late case submission risks.
• Designed and implemented KPI dashboards improving compliance visibility and executive-level risk reporting.
• Partnered with Regulatory Affairs, Clinical Development, Safety Operations, IT, and Global QA to align pharmacovigilance strategy with regulatory expectations.
• Provided Quality & Compliance oversight during global PV system migration (Argus / ArisG), ensuring regulatory continuity throughout the transition lifecycle.
• Collaborated with PV Operations, IT/Validation, and Regulatory stakeholders to ensure validation documentation (URS, IQ/OQ/PQ review support), SOP updates, and procedural harmonization met ICH, GVP, FDA, and EMA requirements.
• Monitored post-migration stabilization metrics to prevent case processing disruption and late safety reporting.
• Strengthened governance controls during migration, maintaining uninterrupted inspection readiness.

Associate Manager - Pharmacovigilance Quality & Compliance at Johnson & Johnson Pvt Ltd (2016-06 – 2022-12)

Advanced global pharmacovigilance quality & compliance framework supporting multinational product portfolio. Led vendor quality oversight, conducted risk-based audits and root cause investigations for delayed safety reporting.

• Led vendor quality oversight, ensuring global SLA compliance and regulatory adherence.
• Conducted risk-based audits and root cause investigations for delayed safety reporting.
• Served as Subject Matter Expert (SME), aligning global and local PV standards.
• Reviewed ICSRs (spontaneous, solicited, literature, clinical trial) within Argus/ArisG.
• Supported signal detection activities, including literature screening and data mining.
• Assisted in Risk Management Plan (RMP) preparation and compliance tracking.
• Contributed to SOP lifecycle management and system validation documentation.
• Strengthened global PV compliance alignment across regions.
• Improved vendor accountability through structured audit and governance mechanisms.
• Developed and delivered PV compliance training, enhancing team audit preparedness.
• Supported PV database Migrations projects by collaborating with multiple stakeholders.

Senior Quality Specialist - Pharmacovigilance at Sciformix Technologies Ltd (2013-02 – 2016-05)

Managed pharmacovigilance workflow operations and quality within the CRO environment, supporting global clients. Oversaw ICSR workflow management, ensuring compliance with international regulations.

• Oversaw ICSR workflow management, ensuring compliance with international regulations.
• Supported aggregate safety reporting and ICSR quality review activities.
• Contributed to CAPA development and regulatory audit preparedness.
• Facilitated knowledge transfer to the Manila safety operations team, ensuring global consistency.
• Enhanced workflow efficiency and case processing accuracy.
• Strengthened quality oversight mechanisms within the CRO framework.

Process Executive - Pharmacovigilance at Tata Consultancy Services (PV) (2009-04 – 2012-06)

Early career foundation in global pharmacovigilance case processing and compliance operations. Managed end-to-end ICSR processing, including MedDRA coding and narrative writing.

• Managed end-to-end ICSR processing, including MedDRA coding and narrative writing.
• Contributed to CAPA implementation, improving operational compliance.
• Ensured adherence to global pharmacovigilance standards and reporting timelines.
• Successfully managed and delivered accurate ICSR processing, elevating adherence to stringent global pharmacovigilance standards.
• Proactively identified and implemented process improvements, culminating in the elevation of the team's efficiency and data integrity.

Master in Pharmacology – Bharati Vidyapeeth College of Pharmacy, University of Mumbai (2006 – 2008)

Bachelor in Pharmacy – Bharati Vidyapeeth College of Pharmacy, University of Mumbai (2002 – 2005)