Medical Science Liaison/ Diabetes- Gulf and Iran
BOEHRINGER INGELHEIM
مجموع سنوات الخبرة :15 years, 11 أشهر
MEDICAL SCIENCE LIAISON, DIABETES - GULF JANUARY 2015 TO PRESENT DAY
Handling Diabetes medical activities for Gulf Region serving as the scientific link between the physicians and the
company.
Responsibility for handling ongoing clinical trials held by the Gulf Cluster Oncology Business Unit in the region covering
Bahrain, Kuwait, Oman, Qatar and the UAE and implement and ensure ICH-GCP and SOPs compliance. Identification of
potential sites, working with ECs and Regulatory on start-up activities. In addition, coordination with Medical team for
disease mapping in the region to better understand and plan proposed trials for the involved countries
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Taking over ongoing studies and work on implementing CAPA put in place by former CRA.
Perform selection of first site in Bahrain and work on achieving a successful and timely approval time.
Build a database for regional ECs and Regulatory bodies, including contact persons, requirments, timelines and any
concerns.
Work with General Medicine Unit in Novartis and Quality Team on identification of gaps present in local SOPs and work
together on putting in place SOPs to address the issue.
Setting base for developing contract issue resolution to help overcome legal issue, place a process sof imp supply in
challenging countruies.
QUINTILES
Monitor a variety of regional sites throughout Egypt and Jordan, with full dedication to a single sponsor, adhering to
sponsor SOPs and acting on their behalf in execution and conduct of the trial. Manage conduct of clinical trials at site
level and evaluate processes. Assure all studies are being conducted according to protocol and aligned with ICH-GCP
Guidelines and country specific regulations.
Took over and handled ongoing sites in
Conducted and monitored 2 Phase III studies in indications as Type 1 Gaucher Disease and 1 Oncology trial.
Maintained completion of required trainings, assuring adherence to CRO and sponsor SOPs and regulatory guidelines.
Aided in the acquisition of new studies by passing multiple successful sponsor audits and performance evaluation
helping growth of Cairo office.
Launched first study ever conducted in Cairo office, partnering with contract teams to identify, select, and close deals
with initial vendors establishing a system for dealing with vendors and a model of running business during trial.
Achieved goal for Gaucher Disease trial through continued staff support in the administration of extended and complex
screening and randomization procedures.
Assisted sponsor to build with investigators a referral network for Gaucher Disease trial helping recruitment of patients
with this rare disease.
Monitored Phase III, IV trials on Type 2 Diabetes Mellitus, Pediatric-Thrombosis, Cardiovascular and Rheumatology.
Evaluated and selected potential sites and prepared facilities for upcoming trials. Co-established clinical trial budgets
and facilitated negotiations regarding research agreements with investigators and institutions. Analyzed study-site
logistics to support pre-initiation phase through site launch. Conducted and orchestrated on-site personnel regarding
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trial-specific procedures, preparations, and maintenance strategies. Examined site closure, managing investigational
product final accountability, reconciliations, and accurate archival of trial documents.
Increased internal ongoing trials by winning several Phase II and III feasibility studies in collaboration with fellow
associates.
Met recruitment target by continuous follow-up with site that where recruited numbers surpassed initial recruitment
projection in a challenging Phase III Pediatric trial.
Assumed responsibility for managing local drug depot, handling temperature monitoring, receiving and dispensing
medication to ongoing trials’ sites.
Successfully passed through a global safety audit conducted by central team.
EARLY DENTAL CAREER
Surgery (