Pharmacovigilance
Over the course of my career, I have developed comprehensive expertise in pharmacovigilance. I have led global projects, collaborated across functions, and delivered high-quality safety outcomes that ensured compliance with Health Authority requirements, maintained inspection readiness, and most importantly, supported patient safety.
Risk Management Plans (RMPs)
I have played a central role in the preparation, development, review, and ongoing updates of Risk Management Plans at both global and local levels. This involved:
- Coordinating contributions from multiple line functions.
- Managing annexes and supporting documentation.
- Ensuring alignment with Health Authority expectations.
- Incorporating regulatory feedback into final deliverables.
Aggregate Safety Reporting
I supported the development of critical aggregate safety reports, including PSURs, PBRERs, and DSURs, ensuring submissions were:
- Timely, accurate, and high quality.
- Fully compliant with global regulatory standards and technical formatting requirements.
Regulatory Intelligence
I contributed to pharmacovigilance regulatory intelligence by:
- Monitoring and reviewing evolving global PV regulations and guidance.
- Disseminating intelligence across internal teams.
- Assessing the impact of new requirements on processes and compliance frameworks.
- Supporting cross-functional teams in the seamless implementation of regulatory changes.
Health Authority Engagement
I have actively collaborated with Health Authorities by:
- Tracking and implementing feedback.
- Clarifying regulatory expectations.
- Ensuring safety commitments were met in line with global agreements.
Audit & Compliance
Working closely with Quality teams, I have:
- Prepared for GVP audits and inspections(FDA, EMA, MHRA).
- Led CAPA management and implementation.
- Developed systems that ensured continuous compliance and inspection readiness.
Vendor & Agreement Oversight
I have managed Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs) by:
- Reviewing and negotiating contract terms.
- Establishing clear standards for safety data exchange.
- Maintaining oversight of global partner compliance.
- Building repositories and templates in collaboration with legal and PV functions.
Operational Excellence
Operationally, I have overseen:
- SAE processing(triage, data entry, coding, narrative writing).
- Signal detection and safety database management.
- Compliant safety data submissions.
- Support for patient narratives and cross-functional safety deliverables.
Collaboration & Leadership
Throughout all my work, I have emphasized collaboration and cross-functional alignment by working closely with clinical development, regulatory affairs, medical safety, and global/local affiliates. My leadership balances:
- Strategy with execution.
- Regulatory compliance with operational excellence.
- Global oversight with local support.