Vice President, Pharmacovigilance & Drug Safety

Summary Description

The Vice President, Pharmacovigilance & Drug Safety will lead and direct the oversight of clinical drug safety risk management and compliance at Geron and will be responsible for product safety-related decisions and recommendations to the Chief Medical Officer. As Head of Pharmacovigilance, the incumbent will assure compliance for all clinical studies in accordance with domestic and international requirements for drug safety oversight and reporting through late-stage development, licensure, and commercialization in the US, Europe, and other regions. The Vice President, Pharmacovigilance & Drug Safety will interact closely with corresponding functional executives within the Company. The position reports directly to the Executive Vice President, Development & Technical Operations, with indirect reporting to the Acting Chief Medical Officer.

Job Description

  • Supervise global Pharmacovigilance activities for imetelstat development program
  • Lead and oversee Pharmacovigilance signal detection and risk management activities and risk mitigation strategies
  • Participate in oversight of patient safety monitoring of ongoing and planned clinical trials
  • Oversee processes for signal identification, assessment, and reporting/communication
  • Lead responses to and/or resolution of regulatory safety enquiries from agencies and health authorities, as the senior Pharmacovigilance expert, and represent Medical Safety at meetings with regulatory authorities
  • Supervise, plan, and support drug safety input into regulatory submissions, including registration product applications and product labeling
  • Lead development of strategies and oversee product risk assessment profiles, including maintenance and updates
  • Provide medical safety expertise in reviewing critical documents with timely communication of safety recommendations and/or actions to internal and external stakeholders
  • Oversee periodic product safety review processes and implementation of recommendations and quality improvements
  • Responsible for clinical safety content of clinical protocols and Investigator’s Brochures
  • Participate in planning, review and approval of clinical trial safety documents and aggregate safety reports (e.g., DSURs, ASRs)
  • Hiring, development and mentoring of Pharmacovigilance & Drug Safety staff
  • Assess and align the organization to meet the goals of the long-range business plan

Qualifications

  • Medical Degree (MD or DO) OR PharmD or equivalent with clinical experience in oncology and with extensive previous pharmacovigilance and drug safety industry experience within biotech or pharmaceutical
  • 15+ years’ experience in pharmaceutical or biopharmaceutical Pharmacovigilance management, preferably in an oncology setting
  • Extensive Pharmacovigilance management experience in a late-stage clinical setting, including oversight of third parties drug safety activities, internal pharmacovigilance review processes and clinical safety assessments, safety signal detection and identification, reporting procedures, and risk management
  • Strong knowledge of global regulatory Adverse Event Reporting requirements and Pharmacovigilance practices
  • Detailed knowledge and in-depth application of GCP, FDA and EU GVP regulations and international guidelines
  • NDA/MAA preparation and product registration experience
  • Track record managing activities to timelines, leading and developing people, working in a multi-disciplinary team environment
  • People management strengths, including the ability to motivate and mentor
  • Excellent written and verbal communication skills
  • Excellent scientific analysis and interpretation skills and the ability to creatively problem solve