Susana Santiso Lopez

Strategic oversight of Safety Data Management

• Functional lead of the main service provider for case processing
• Oversee safety data collection, processing, and compliance across the organization.
• Ensure alignment with industry best practices, regulatory requirements, and business rules and proactively address compliance gaps. Advise on necessary changes to align with evolving regulations.
• Offering expert input across clinical activities and post-marketing activities and resolving queries related to safety data management.
• Assess and monitor quality and metrics KPIs as well as reconciliation activities.
• Responsible for optimizing processes for efficiency and effectiveness.
• Foster effective relationships within a large cross-functional team. This involves collaborating with IT, project management, clinical experts, data management and external vendors to optimize safety data management.
• Communicate directly with regulatory authorities regarding safety matters.
• Provide comprehensive training to both safety and non-safety staff, ensuring a clear understanding of their responsibilities in adverse event processing.

Vendor Management

• Active collaboration in strategic sourcing and procurement process by assessing, selecting, and onboarding vendors aligned with organizational goals.
• Negotiate contracts, ensuring favorable terms for the organization.
• Cultivate and maintain strong relationships with vendors and partners.
• Assess and monitor vendor performance throughout the contract lifecycle, ensuring adherence to operational plans, and address any gap or issue.
• Manage vendor budgets, tracking expenses and cost-effectiveness.

Budget Oversight

• Manage departmental budget, ensuring adherence to financial plans.
• Analyze financial performance to inform budget decisions.
• Collaborate with department head to understand needs and priorities.
• Distribute costs based on departmental requirements and prioritize essential initiatives and projects.
• Regularly monitor expenses in real time and optimize spending while maintaining quality and compliance by making necessary adjustments to optimize resource utilization.

Global Safety Database Leadership

• Provide expert user guidance for safety database maintenance, update, and upgrades in compliance with business rules and international requirements.
• Act as the main primary contact point for all safety database users.
• Active contributor to ensure the quality of system deliverables including design/configuration specifications, system and user acceptance testing, software installation and the completion of required documentation.
• Direct communication with the regulatory authorities regarding safety for set-up and maintenance of electronic exchange of case between the agencies and the company via Gateway.

Quality Management System (QMS)

• Strategic oversee on deviations of the Pharmacovigilance system by ensuring timely action as per established deadlines.
• Safety oversight across local activities for global markets and CROs potentially triggering collection of safety information.
• Develop and maintain pharmacovigilance local and global Standard Operating Procedures and ensure consistency across local and global Pharmacovigilance practices.
• Crucial role in overseeing and participating in audits and inspections as safety data matter expert by reviewing processes, documentation, and systems and ensuring timely responses to audit and inspection findings and implementing necessary improvements

Trusted Deputy (TD) role in Eudravigilance

• Appointed as Trusted Deputy (TD) role of the organization in Eudravigilance to ensure business continuity and support the QPPV role in the Eudravigilance administrative tasks.

Innovation and Technology Evaluation

• Explore emerging technologies including AI for safety case intake, processing, signaling, reporting and analytics.
• Evaluate vendor products and propose enhancements.
• Lead change management, development, testing strategy, implementation, deployment strategy, and hyper care support for new solutions and for ongoing technical enhancements of existing solutions.
• Align Pharmacovigilance solutions with organizational growth objectives.

• Management of pharmacovigilance activities in collaboration with different internal and external stakeholders to ensure the safety of company marketed or investigational products.
• Management of safety operations vendor including definition of activities, set up of safety processes and performance monitoring
• Monitored deliverables for quality and adherence to regulatory reporting timelines.
• Operational support to clinical trial activities including but not limited to SAE management, reconciliation, unblinding activities as well as support in safety monitoring activities during development
• Operational support to other studies (such as non-interventional studies, market research, registries) activities including but not limited to ICSR management, reconciliation, as well as support in safety monitoring activities.
• Responsible for the preparation of the pharmacovigilance clause included in licensing agreements and for the establishment/revision of safety agreements and their negotiation with partners.
• Responsible for PV affiliates and CROs oversight as well as support in business development activities that require of PV integration activities.
• Contribution to the establishment and performance of the Pharmacovigilance Quality Management System, including PSMF maintenance, fulfilling KPIs and GDPR requirements, and develops and implements new or improved pharmacovigilance procedures required by internal policies and applicable legislation.
• Cooperation in the conduction of internal and external audits and inspections.
• Responsible for training on pharmacovigilance activities of new employees and external vendors.
• Support to the maintenance of the safety database (ARISg) in compliance with business rules and international requirements.
• Support to any implementation, update and/or upgrade related to the safety database.
• Support for all safety database Users acting as a main contact point for any safety database related issues.

• Management of corporate pharmacovigilance, including processing of postmarketing ICSRs and SAES from clinical trials, and responsible for operational activities related to safety database.
• Support in PSUR preparation to ensure data completeness by the time of data lock point as well as providing tables and listings for aggregate reporting.
• Create, update and review procedures related to safety operational activities.
• Ensures compliance towards regulatory requirements as well as towards internal need in terms of timelines and quality.
• Provides operational support to Almirall market companies and partners

• Administrative and technical support to the pharmacovigilance department

• Administrative support to sales department

• Administrative support to the department

• Maintained quality documentation and records for conformance with relevant standards.

• Design and perform laboratory experiments. Recording and analyzing the data and observations.