Experience

CROMSOURCE - A ClinChoice Company

• Italy
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Medical Monitor

  • Sep 2015 - Present

  Verona



Worldwide Clinical Trials

• United States
• Research Services
• 700 & Above Employee

• Associate Director, Medical Monitoring & Drug Safety

  • Nov 2009 - Jun 2014



TransPerfect

• United States
• Translation and Localization
• 700 & Above Employee

• Medical Writer and Translator

  • Jun 2008 - Nov 2009



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Research Manager

  • Sep 1998 - May 2008

  In conjunction with the International Coordinator, ensure the successful startup and management of clinical trials in Italy. Main therapeutic areas recently covered : migraine, lipidology, HIV, vaccines,depression. Ensure the timeliness of ERC submissions. Provide the CRAs with the medical knowledge needed when interpreting protocols and interacting with investigators; manage the CRAs, select and hire new CRAs; assign projects according to available manpower; relay messages from… Show more In conjunction with the International Coordinator, ensure the successful startup and management of clinical trials in Italy. Main therapeutic areas recently covered : migraine, lipidology, HIV, vaccines,depression. Ensure the timeliness of ERC submissions. Provide the CRAs with the medical knowledge needed when interpreting protocols and interacting with investigators; manage the CRAs, select and hire new CRAs; assign projects according to available manpower; relay messages from Headquarters regarding clinical research in general (eg, procedure updates etc.); assist the Clinical Research Director in assessing productivity, communicating with Headquarters, deciding wich protocol to take on, preparing presentations for regional directors meetings etc. Work in conjunction with the CRAs in monitoring preregistrative clinical studies.

• Product Physician

  • Sep 1997 - Aug 1998

  Cooperate with the Medical Affairs Associate Director in providing medical expertise supporting marketing of rizatriptan (MAXALT, indication: migraine) and launch of montelukast ( SINGULAIR, indication: asthma ): training of reps, relationships with opinion leaders etc. As an assignment, monitor a preregistrative clinical research study according to Merck procedures, ICH and all applicable laws and regulations, including adverse experience reporting.

• Pharmacovigilance and Medical Services Manager

  • Mar 1991 - Aug 1997

  In charge of: -reporting of adverse experiences, both spontaneous and Investigational, to Headquarters and Italian Agency, in compliance with Merck procedures and all applicable laws and regulations; -follow up of adverse experiences; -updating of adverse experience reports; -on behalf of Headquarters, contacting reporting physicians to obtain additional information, clarify drug relationship etc. Furthermore, medical revision of promotional material, including scientific… Show more In charge of: -reporting of adverse experiences, both spontaneous and Investigational, to Headquarters and Italian Agency, in compliance with Merck procedures and all applicable laws and regulations; -follow up of adverse experiences; -updating of adverse experience reports; -on behalf of Headquarters, contacting reporting physicians to obtain additional information, clarify drug relationship etc. Furthermore, medical revision of promotional material, including scientific articles and books.



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Medical Publications Associate

  • Jan 1988 - 1991

  Revision of scientific translations/articles on Merck products and relevant therapeutic areas.