USA/Remote
Key Responsibilities:
• Leads all aspects of safety for Clinical Development Programs at HighTide
• Responsible for managing the Contract Research Organization providing PV/Case processing services
• Provides medical monitoring oversight for ongoing clinical trials
• Responsible for safety data interpretation including monitoring and review of safety data from ongoing clinical trials, clinical study results, responses to safety related questions from Health Authorities
• Collaborates with Clinical Development, Clinical Operations, Quality, and Regulatory Affairs to provide input and oversight for all safety related topics (i.e., Clinical Study Protocols, Investigator’s Brochure, Informed Consent Document etc.)
• Executes the preparation of key safety documents for Health Authorities (e.g., DSUR, periodic line listings), Investigator communications, and other reports, as necessary
• Supports activities for Data Monitoring and responds to Committees
• Supports Health Authority inspections and internal audits including corrective action plans
• Ensures that the PV function is inspection-ready at all times
Requirements:
• Medical Degree (MD, DO) is required; specialty training / board certification, especially in Hepatology or Gastroenterology is strongly preferred
• Over 10 years of experience in the pharmaceutical industry, including at least 3 years in a leadership/management position in PV
• Expert knowledge of FDA and EMA/CHMP regulations and guidelines, EU GVP Modules ICH guidelines, and other international regulatory requirements
• Working knowledge of NMPA (China) regulations and guidelines is desirable
• Experience in overseeing safety operations outsourced to Contract Research Organizations
• Strong knowledge of Pharmacovigilance technologies i.e., Safety databases
• Ability to effectively communicate scientific information (excellent written, verbal and presentation skills)
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
Contact
careers@hightidetx.com
We will contact you as soon as possible
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