MAY'S HOT JOB

Vice President / Global Head
DRUG SAFETY AND PHARMACOVIGILANCE

This Company would like to establish and in-house Pharmacovigilance group.  If you are ready to take on the challenge contact Rich now for additional details on this exciting opportunity.

Contact
Rich Connors
rich@vista-technology.com

MISSION STATEMENT:
The Worldwide Head of Drug Safety and Pharmacovigilance will be responsible for all clinical and post-marketing filings to insure consistency of safety assessment, analysis and regulatory compliance with all aspects of product safety reporting. 

RESPONSBILITIES: 

• Serve as the Medical Safety Officer for Worldwide Drug Safety and Pharmacovigilance.
• Develop the infrastructure necessary for building an independent Drug Safety / Pharmacovigilance department including the creation of systems and processes.
• Provide strategic direction for the ongoing development of the department
  Oversee and approve the reporting of Drug Safety and Pharmacovigilance information to regulatory bodies.
• Serve as the internal subject matter expert on all relevant Drug Safety and Pharmacovigilance regulations and guidances, including those promulgated by the FDA, EMEA and ICH.
• Assist with clinical trial design and work within the Product Development Teams to ensure compliance with GCP guidelines.

QUALIFICATIONS:

• RN, RPh, PharmD, MD with a minimum 5 years of product safety experience including supervisory.
• Experience in all aspects of safety reporting for clinical studies and marketed products.
• Thorough understanding of the regulatory environment for pharmacovigilance including FDA and ICH guidelines.
• Experience with clinical trial development and execution.
• Successful experience in leading cross-functional teams.
• Computer competency required.

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