Sara Magdy Mohamed

• Monitor of local regulatory intelligence sources for PV relevant updated to the local regulatory intelligence in scope of the project.
• Document and QC the results of Local regulatory intelligence monitoring activities
• Reporting and translating of PV relevant information to the local regulatory intelligence in scope of the project, as required.

· Oversee the work performed by the project team members and ensure a high standard of quality and timeliness of work delivered to the client;

· Maintain project tracking and systems; oversee project resource through time monitoring against agreed project; and provide agreed reports to Drug Safety department leadership and to clients

· Support the commercial unit in scoping, proposal, and/or contractual agreements preparation;

· Assessment of technical activities required for project setup;

· Participate in business meetings, bid defenses with current and potential clients;

· Participation in the kick-off meetings with clients;

· Local project management (Local literature monitoring, Local ICSR processing, LPPV/LSO management, Monthly reporting and compliance monitoring);

· Management of project related Global Drug Safety contracts (Global Drug Safety service agreements, Safety data exchange agreements);

· Support the development and revision of Safety Management Plans;

· Support provision of Global Drug Safety training to project and internal teams as well as other departments;

· Improvement of processes within the assigned Unit, ensuring a smooth run of the project, tasks and processes; ability to capture all running projects, tasks and processes within the unit and their relations to other units within the Global Drug Safety department.

• Execute project tasks primarily specific to the unit, but also cross-functional, including without limitation Global ICSR processing, Global Literature monitoring, Signal Management and Benefit Risk Management activities, Medicinal Product Management (XEVMPD), Local project management (Local literature monitoring management, Local ICSR management, LPPV/LSO management, Monthly reporting and compliance monitoring), Regulatory Intelligence, preparation and QC of pre-marketing and post-marketing aggregate reports (e.g. PSUR, DSUR, PBRER, PADER, etc.) Risk Management Plans (RMP), Study protocols (interventional and non-interventional studies), product documentation (SmPC, IB), Pharmacovigilance system master file (PSMF), Management of project related PV contracts (PV service agreements, Safety data exchange agreements), Pharmacovigilance system master file management;
• Execute other project specific task as and if required;
• Involvement together with other team members in the scoping phase when and if required;
• Support the PV Business Manager in proposal preparation as and if required;
• Improvement of processes within the assigned Unit, ensuring a smooth run of the project, tasks and processes; ability to capture all running projects, tasks and processes within the unit and their relations to other units within the PV department;
• Oversee the work performed by the project team members (PV associates, PV assistants) and ensure a high standard and quality of delivered work.)

• Supervised team of 3 employees to maintain optimal performance and consistent operations.
• Tracked deadlines and submitted accurate reports to missing or dropping of products.
• Created culture of continuous improvement, inspiring employees to take action and solve problems.
• Communicated with customers regarding product information, complaints and issues.
• Assigned tasks to team members based on individual strengths and promoted teamwork-driven environment to meet goals.
• Produced weekly reports outlining operational successes and gaps for use of senior management team.
• Monitored performance metrics focused on driving results of key business areas.
• Reported on audit findings via verbal presentations and detailed written reports.
• Conducted audits and communicated findings in formal audit reports.
• Detailed disaster recovery plans and assessments for senior management to maintain readiness and drive necessary change to current business strategies.
• Drive continuous improvements local safety capabilities in operational PV and safety science expertise, including the ability to apply safety insights in the local context.
• Developed team members'' skills through targeted coaching sessions, resulting in improved individual performance.
• Empowered team members by delegating responsibilities according to individual strengths and areas of expertise.
• Assisted in recruitment to build team of top performers.