Stefano CLEMENTI

  • 69221 Dossenheim -Germany

Drug Safety Specialist and Coordinator

Work History

Work History
Nov 2012 - Present

Drug Safety Specialist and Coordinator

spm2- safety project and more

Drug safety activities:

• Manage the receipt and processing of all adverse event reported either from clinical trials or post marketing sources according to best practice and national and international guidelines and regulations
•  E2B Expediting reporting to worldwide regulatory agencies
• Medical Devices serious adverse events (SAEs) reporting under directives 90/385/EEC and 93/42/EEC.
• Preparation of Periodic Safety Update Reports (PSURs), Development Safety Update Report (DSUR), Risk Management Plan (RMP) and FDA IND Annual Report
• Data management and reconciliation of safety databases and clinical database
• Case processing Quality Review under ISO 2859-1 (Sampling procedure for inspection by attributes)
• Maintenance of and compliance to Pharmacovigilance Sysem Master File (PSMF), preparation of Standard Operating Procedures (SOPs,) Work Instruction (WI) and client addressed Projects Specific Procedures (PSPs)
• Process of EU/US Authorities specific requests (Safety Data Analysis, safety reports)


Coordinator activities:

• Participation in staff meetings
• Support and coordination of personnel planning
• Project specific training of the new personnel
• Support with the allocation of projected resources
• Monitoring and regular reporting of program processes and standards, quality metrics, technology needs and project allocation for the projects within a program
• Generation of the monthly project and performance evaluation
• Overview, management and communication of project / program timelines
• Preparation of partnership meetings
• Cooperation in the generation of cost offers, and monitoring of the request of charges

Apr 2009 - Nov 2012

PhD student/EU Marie Curie Fellowship

Central

Molecular and behavioral characterization of animal models genetically manipulated to unravel the role of Nogo-A and Staufen 2 proteins in cognitive processes

Education

Education
Apr 2009 - Aug 2013

PhD Biology

Ruprecht-Karls-Universität Heidelberg
Sep 2003 - Apr 2009

Pharmaceutical Biotechnology Master Degree

University of Camerino (Italy)

Certifications

Certifications
2014 - Present

IND and Post-Marketing

DIA- Drug Information Association

Adverse Event Reporting Requirements: IND and Post-Marketing

Jan 2015 - Present

Advanced negotiation skill

Scotwork

Seminare zum Ausbau der Verhandlungstechniken

About me

I am an open-minded, friendly and resourceful person who has developed a mature and responsible approach to any task that I undertake, or situation that I am presented with. I have a strong and extensive scientific background that helped me to gain experience in the pharmacovigilance field. I posses an excellent ability to work in a team to achieve a certain objective on time and with excellence. My key strength is quickly learning new tasks. I´m searching new challenges in my career in drug safety.