Director, Global Pharmacovigilance

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

HighTide,君圣泰,君圣泰医药,非酒精性脂肪性肝炎,nash,2型糖尿病,t2dm

We will contact you as soon as possible

HighTide,君圣泰,君圣泰医药,非酒精性脂肪性肝炎,nash,2型糖尿病,t2dm HighTide,君圣泰,君圣泰医药,非酒精性脂肪性肝炎,nash,2型糖尿病,t2dm HighTide,君圣泰,君圣泰医药,非酒精性脂肪性肝炎,nash,2型糖尿病,t2dm HighTide,君圣泰,君圣泰医药,非酒精性脂肪性肝炎,nash,2型糖尿病,t2dm

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