Amani Alashqar

In addition to core LSO responsibilities, I have assumed

• Expanded leadership of the Gulf PV Team, overseeing operations, compliance, and direct reports across Gulf countries
• Took on strategic oversight tasks previously managed by the Country Safety Head, including operational compliance, audit readiness, and cross-regional alignment.
• Contributing as O/H Medical Affairs Project Manager (Job Rotation, 30% FTE), supporting the Oncology & Hematology BU in executing the Medical Affairs plan, medical education initiatives, and scientific content development.
• Driving impactful collaboration across Medical Affairs and PV, bridging safety oversight with medical strategy.

• Ensured oversight of product vigilance and risk management systems in compliance with local and global regulations.
• Managed LOC safety activities for medicinal products in line with regulatory requirements and PV agreements with business partners.
• Supported safety reporting requirements for MAHs and study sponsors, ensuring compliance throughout product lifecycles.
• Provided support to the KSA PV team on defined processes, such as business continuity plans and document management.
• Actively contributed to initiatives aligning with local, regional, and global medical safety vision.

• Reported adverse events and supported compliance with local and global PV requirements.
• Contributed to risk management and safety-related regulatory submissions.

• Responded to medical inquiries and PV case reporting.
• Supported marketing and sales departments on medical and scientific issues.
• Summarized bioequivalence trials for GCC product registrations.
• Led cross-functional project management for timely, compliant deliverables.