Core Areas of Expertise – Detailed Profile

My career path has allowed me to work in both operational and strategic roles - building, optimizing, and overseeing pharmacovigilance systems in line with EU GVP and international expectations.

The following areas summarize the depth and scope of my expertise:

Risk-Based Audit Systems

• Deep expertise in PV Quality with a specialization in EU GVP Module IV

• Designed, implemented, and optimized risk-based audit systems for both PV partners and internal critical PV processes

• Conducted risk assessments with PV partners, affiliates, and for critical PV processes

• Developed and managed strategic and tactical audit programs

• Led and enhanced the pre-qualification process for prospective PV partners

Audit & Inspection Experience

• Supported and co-conducted over 100 global audits, including writing audit reports and classifying findings

• Oversaw CAPA lifecycle management from root cause analysis to effectiveness checks

• Experienced in EU and non-EU inspections as Inspection Coordinator, Scribe, and Interviewee

• Directed pre-inspection readiness and post-inspection follow-up efforts

PV System & Quality Management

• Drafted, revised, and streamlined SOPs and other essential quality documentation

• Developed and rolled out PV processes such as reconciliation with partners and affiliates

• Managed deviations and CAPAs in alignment with quality expectations

• Set up end-to-end PV system considering all PV activities, ensuring alignment across departmental interfaces

• Authored and maintained PSMFs and PSSFs (e.g., Saudi Arabia)

• Combined regulatory compliance with practical implementation and operational efficiency

Operational Pharmacovigilance

• Processed ICSRs including MedDRA/CTDAE coding, WHO-UMC causality assessments, and listedness evaluations

• Performed literature screening in alignment with regulatory expectations

• Interpreted PV data and scientific literature to respond to medical inquiries

Contract & Partner Management

• Negotiated, maintained, and terminated 50+ PV agreements and addenda with licensing, distribution, and post marketing study partners

• Managed comprehensive PV partner databases and records

• Led partner and affiliate meetings and offered actionable PV guidance

• Coordinated PV activities across affiliates and ensured alignment of LCP responsibilities.

• Ensured compliance with EU and international PV regulations across collaborative networks

Training & Consulting

• Delivered targeted pharmacovigilance training, such as for the local QPPV at global partners 

• Designed and conducted annual training programs tailored to compliance needs

• Offered regulatory consulting in PV Quality and compliance strategy for PV partners

Key Skills & Strengths

• Structured, analytical, and reliable approach to complex topics

• Strong intercultural communication and collaboration capabilities

• Proficient in leading and executing complex cross-functional projects