Director, Patient Safety and Pharmacovigilance

Position Summary

We are seeking an experienced pharmacovigilance physician to support the development of a promising drug candidate in Phase 3 clinical trials.

Reporting to the VP, Clinical Development, the successful candidate will play a crucial role in ensuring patient safety and regulatory compliance throughout the drug development process for a key asset. Key responsibilities include, but are not limited to, oversight of external pharmacovigilance vendor, expert medical review of accumulating serious adverse events in ongoing studies, oversight of safety-related regulatory documents (including safety components of BLA submission) and medical leadership of internal safety review committee. The incumbent will also contribute to the development of internal safety infrastructure. This key position demands strong collaborative and communication skills, including the ability to engage with a diverse range of internal and external stakeholders.

Key Responsibilities

• Review and assessment of emerging safety profile, focusing on serious adverse events (SAEs) and potential safety signals from ongoing Phase 3 studies
  • Performing signal detection, monitoring and evaluation of all safety signals.
• Provide medical oversight for safety surveillance activities and risk management for the Phase 3 drug development program towards BLA submission
  • This will involve the day-to-day management of external pharmacovigilance vendor relationships including oversight of safety database maintenance and case processing
• Oversee the development and maintenance of safety-related documents including Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), safety sections of the Investigator Brochures, and Risk Management Plans (RMPs)
• Collaborate with individual study medical monitors to evaluate accumulating safety data
• Lead safety review committees and provide medical expertise in safety-related decisions
• Interface with regulatory authorities regarding safety matters and respond to safety-related queries
• Lead preparation of safety components for BLA submission, including:
  • Safety sections of Clinical Study Reports
  • Response to regulatory safety queries
• Ensure compliance with global safety regulations and reporting requirements
• Contribute to the development of company-wide safety strategies and processes

Qualifications

• MD (Board certified or equivalent)
• Experience in hepatology, MASH or internal medicine preferred
• 3+ years of experience in pharmacovigilance, patient safety or related field in the biopharmaceutical industry

• Experience in preparing or contributing to the preparation of clinical safety assessments and regulatory reports/submissions involving safety information in Phase 3 clinical studies

• Thorough understanding of global pharmacovigilance regulations and guidelines (ICH, FDA, EMA)
• Strong knowledge of drug safety databases and safety reporting requirements
• Experience with signal detection and risk management methodologies
• Prior experience with preparation of documentation of NDA/BLA/MAA submissions an advantage
• Ability to forge cross-functional working relationships with internal teams and external project partners

Technical requirements and skills

• Excellent written and verbal communication skills
• Excellent understanding of medical terminology and ability to evaluate complex medical information
• Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
• Able to work both independently and in a team environment, including with external vendors.
• Detail-oriented, with good organizational, prioritization, and time management proficiencies, and able to work on multiple projects simultaneously.

Compensation

• Below is the pay range for this position that we reasonably expect to pay. Individual compensation is based on a number of factors including, experience, education and skill set, and geographic location. This range is for the San Francisco Bay Area, California location and may be adjusted to the labor market in other geographic areas. 

  Pay range: $250,000 - $300,000 per annum