Inayat K

Manager Pharmacovigilance

Oct 2023 - Apr 2026 • 2 yrs 6 mos

• Maintained and continuously developed PV systems for multiple MAH clients, conducting gap assessments and implementing targeted improvements, achieving zero critical findings across all regulatory audits and inspections. • Managed the full lifecycle of SDEAs and PV Agreements with international partners: drafting, negotiation, periodic review, obligation tracking, and compliance monitoring in line with EU GVP Module I. • Owned PV QMS activities including SOP authoring and review, deviation management, CAPA strategy, and effectiveness tracking; maintained audit-ready documentation at all times. • Designed and delivered role-based PV training programs for cross-functional teams, affiliates, and partner organisations; managed training records and monitored GVP compliance completion rates. • Led inspection readiness strategy across EU, UK, LATAM, SEA, and EAEU regions; acted as primary PV liaison with QPPVs, global safety teams, Health Authorities, affiliates, and distributors. • Oversaw safety database governance (Argus, Clinevo) configuration compliance, data integrity, and regulatory alignment across all product portfolios. • Authored and reviewed aggregate safety reports (PSUR/PBRER/PADER) in compliance with global regulatory timelines; designed and maintained RMPs aligned with EU GVP Module V. • Supported PV due diligence and onboarding for new client partnerships including gap analysis, remediation planning, and inspection readiness from contract inception.

Pharmacovigilance Officer

Jul 2022 - Oct 2023 • 1 yr 3 mos

• Drafted, reviewed, negotiated, and maintained SDEAs and PV Agreements with trading partners across EU, UK, and emerging markets; managed agreement registers and partner obligation tracking. • Maintained PSMF documentation and supported QPPV oversight frameworks in alignment with EU GVP Module I requirements. • Contributed to PV QMS activities: SOP review cycles, deviation management, compliance KPI monitoring, and periodic management review reporting. • Supported inspection readiness through documentation review, gap analysis, and CAPA coordination; maintained audit-ready filing systems throughout. • Contributed to RMP updates, safety variation management, and PADER data compilation across EU, UK, and emerging market product portfolios.

Team Lead- Pharmacovigilance

Mar 2019 - Jul 2022 • 3 yrs 4 mos

• Led end-to-end ICSR processing for global pharmaceutical sponsors, ensuring compliance with FDA, EMA, and MHRA reporting timelines across multiple product portfolios. • Reduced procedural deviations by 40% through SOP harmonisation, process redesign, and structured QC checkpoints, delivering measurable improvement in PV QMS performance. • Managed, mentored, and trained a PV operations team; drove quality performance and professional development across junior and mid-level staff. • Implemented KPI dashboards and compliance metrics reporting for management and global sponsors, enabling data-driven improvement and proactive issue resolution. • Contributed to aggregate reporting (PSUR/PBRER, DSUR) through signal detection and cumulative safety data analysis; supported audit readiness and CAPA implementation.