Director, Safety/PV

Website HighTide Therapeutics

Founded in Shenzhen, China, HighTide Therapeutics is a global clinical-stage biopharmaceutical company focused on discovering and developing novel drugs to treat chronic liver diseases, gastrointestinal diseases, and metabolic disorders with high unmet needs. The company integrates expertise in disease biology, medicinal chemistry, clinical development, and regulatory affairs to advance its growing pipeline of drugs. The company’s lead drug candidate, HTD1801, is a first-in-class new molecular entity, currently in Phase II trials for the treatment of primary sclerosing cholangitis (PSC), and nonalcoholic steatohepatitis (NASH). The FDA has granted HTD1801 Fast Track Designation in both diseases.

 

Director, Safety/PV

JOB TYPE: Full-time

Location: Shenzhen/ Shanghai, China

 

Key Responsibilities:

  1. Establish and maintain a thorough understanding of project protocol, budget, and scope of work (SOW) for assigned projects; set up and maintain project materials such as project files, forms, templates, databases, and workflow.
  2. Track SAEs and AEs occurrences during clinical trial development and analyze available safety data periodically.
  3. Create and maintain drug safety/PV relevant work instructions, process guidelines, and SOPs.
  4. Prepare and maintain company core safety information and create a safety review plan.
  5. Maintain DSUR and IB and responsible for revisions annually.
  6. Provide comprehensive feedback on project team members for input into appraisals. Provide consistent and frequent feedback to department heads on staff quality and progression.
  7. Provide PV/drug safety-relevant training to CRAs/vendors if necessary; address drug safety-relevant questions raised by the site.

 

Skills:

  1. Bachelor’s degree or above with a major in medicine/related.
  2. At Least 10 years of industry experience (biotech/pharma/ CRO) with expertise in managing and overseeing the activities.
  3. Good knowledge of pharmacovigilance-relevant regulations.
  4. Excellent written/oral communication skills (local language and English) with proven ability to negotiate and communicate with internal and external stakeholders.
  5. Ability to priorities under pressure.
  6. Well-developed organizational skills.

 

Contact: Lin Zhang

Email: zhanglin@hightidetx.com

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