CV Sciences Inc (CVSI)

[IAmTopG]

Only copied pasted relevant stuffs. I hope this is for real as I am terribly dissapointed to get in big time at $0.52. Pretty sure he is being brought in to help with CT of CV007..


https://www.linkedin.com/in/stephen-schmitz-md-mph-48a5873/



1. Medical Director, Global Pharmacovigilance
Company NameLantheus Medical Imaging
Dates EmployedDec 2008 – Sep 2012 Employment Duration3 yrs 10 mos
LocationN. Billerica, MA

Responsible for overseeing all pharmacovigilance activities for all marketed products and clinical trials
Oversee the Drug Safety CRO who holds our safety database.
Led a successful MHRA pharmacovigilance inspection and reinspection
Supervise the Associate Director, PV Operations
Develop a comprehensive, systemic approach to health hazard assessments and risk assessment related to product quality issues
Collaborated with clinical group on safety assessment of Phase III clinical trial
Respond to medical information queries and develop medical information contact for numerous products
Perform weekly medical literature searching for PVG and clinical development.
Serve as medical monitor for Phase IV study
Develop protocols for retrospective studies using a large hospital database.
Support the marketing effort through educational programs on product safety targeted for health care professionals

2. Stryker Biotech
Director, Clinical Development and Medical Affairs
Company NameStryker Biotech
Dates EmployedSep 2007 – Jul 2008 Employment Duration11 mos

Responsible for serving as medical monitor for Phase I and III studies in medical device and biologic. Specifically, serve as medical monitor for a Phase III trauma study, for a Phase I study in degenerative disc disease of the lumbar spine, and oversee Investigator Initiated Trials.
Support the Pharmacovigilance group by reviewing all serious and non-serious adverse events and product complaints, and working with Quality Group on trending of product complaints.
Support Sales and Marketing division by providing medical information summaries
Author clinical and safety sections of Investigator Brochure updates, protocol amendments, annual reports, periodic safety update reports, and other regulatory submissions (e.g., PMA)


3. Averion Inc
Vice-President, Medical and Regulatory Affairs
Company NameAverion Inc
Dates EmployedMay 2004 – Sep 2007 Employment Duration3 yrs 5 mos

Responsible for directing and coordinating all aspects of medical affairs (medical writing, safety/pharmacovigilance, data monitoring committees); directing and coordinating timely regulatory submissions, providing regulatory guidance at all levels of product development; interfacing and maintaining relationships with domestic and international regulatory authorities; training in-house staff in medical issues and provide internal medical consultation to Averion; reviewing clinical documents and publications; and participating in internal, Client/Sponsor, and scientific presentations.
Current client base includes medical device companies (50%) and drug (25%) and biologics (25%) companies.


4. Transkaryotic Therapies, Inc
Director
Company NameTranskaryotic Therapies, Inc
Dates EmployedMay 2002 – May 2004 Employment Duration2 yrs 1 mo

Responsible for overseeing safety in the clinical trial setting and post-marketing (Europe). Worked closely with clinical affairs in development of phase II/III protocol for Hunter syndrome.
Actively participated in clinical team in preparation for an Advisory Committee meeting for Replagal®.
Critical contributor to the project team for I2S, an enzyme replacement therapy for Hunter syndrome.
Authored solely or contributed to annual reports for several products, the Periodic Safety Update Report (PSUR) and Complete Response for Replagal. Communicated with FDA in written and oral form on a regular basis. Worked with Medical Affairs in the development of pre- and post-launch materials for Replagal®.


5. Biogen, Inc
Associate Medical Director
Company NameBiogen, Inc
Dates EmployedMay 1998 – May 2002 Employment Duration4 yrs 1 mo
Responsible for overseeing post marketing safety database of Biogen's marketed products; providing medical oversight to investigational new drug in phase II and phase III (natalizumab); developing and implementing a global medical information system; supervising the manager of Medical Infomatics and Data Specialist function; writing a variety of safety documents for global dissemination (e.g., standard medical letters); preparing regulatory reports for the US and Europe; coordinating special epidemiologic projects using large, retrospective databases.