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Director, Clinical Safety and Pharmacovigilance

SUMMARY

The Director of Pharmacovigilance is responsible for leading the analysis of emerging clinical safety data, while developing safety strategies for Adaptimmune.  They will be accountable for ensuring effective pharmacovigilance practices and the quality of all drug safety programs and drug safety deliverables. This will include:

  • Directing responsibility for safety surveillance activities, adverse event assessment and reporting, leading safety review teams and other safety meetings, and otherwise providing pharmacovigilance scientific support and guidance across the Adaptimmune organization
  • Leading the medical assessments of all adverse event findings, including those requiring submission to regulatory authorities
  • Driving short-term and long-term strategic planning for the safety of patients treated with Adaptimmune products and the development of Safety and Pharmacovigilance Department policies
  • Contributing to the implementation and maintenance of Pharmacovigilance Systems (procedures, training, databases etc.)

This a global role that will work closely with members of the U.S. and U.K. clinical strategy and development teams, preclinical safety, regulatory, clinical operations, biometrics and compliance.

 

RESPONSIBILITIES

  • Oversee all aspects of drug safety surveillance including review of adverse event data, literature, and other Safety-relevant data for the purpose of signal detection and evaluation
  • Ensure subject safety in drug development activities in compliance with regulatory requirements and company standard operating procedures
  • Review study progress and collate emerging patient data in the Company‚Äôs clinical trials and long-term safety studies into summary reports for regulatory submissions, publications, and KOL/investigator meetings
  • Contribute to overall benefit-risk evaluations including presentations to the Safety Governance Board, and preparation for any applicable regulatory obligations
  • Management of Pharmacovigilance systems (safety procedures, pharmacovigilance training, safety databases, Pharmacovigilance master file)
  • Lead safety review meetings
  • Direct the medical assessments of all adverse event findings, including those requiring submission to regulatory authorities, including but not limited to individual case safety reports (ICSRs), IND Safety Reports, INDs, NDAs, annual report summary statements, and Periodic or Developmental Safety Update Reports (PSURs/DSURs).
  • Drive core safety information updates and initiatives based on data from signal detection, clinical practice, or scientific research.
  • Keep abreast of new safety regulations and guidance from the regulatory authorities
  • Provide leadership and guidance during internal and external safety audits and oversee and guide remediation of any Pharmacovigilance deficiencies cited during regulatory or internal audits
  • Prepare and review safety section of IBs, Protocols, Informed Consent, adverse event CRF pages, Clinical Reports, and IND/NDA/other regulatory submissions
  • Organize and manage Safety Review Committee meetings and other interactions with external safety experts
  • Contribute in the development and provide safety contents for risk management plans
  • Lead authorship and provide content for periodic safety reports; e.g., development safety update report (DSURs)
  • Contribute to the evaluation and management of safety related product quality incidents.  
  • Participate in interactions with investigators and site staff ensuring the effective exchange of emerging clinical and safety data. This may include periodic site visits, collaboration with clinical operations colleagues, site training on adverse event reporting, and participate in face to face meetings at relevant conferences  
  • Occasional domestic and international travel is expected

 

REQUIREMENTS

  • Minimum of a BA/BS in Life Sciences Required, Advanced degree preferred
  • 5+ years of industry pharmacovigilance experience, preferably including oncology and/or immunology
  • Experience with biologics or cell and gene therapy is helpful but not required
  • Strong knowledge of pharmacovigilance regulatory process (FDA and EMA) is required, preferably including risk management plans and REMS
  • Experience with safety databases
  • Proven experience independently running/managing the clinical safety of at least one clinical/pharmacology project, preferably in oncology or immunology
  • Ability to work flexibly and take on new tasks in a small company environment
  • Strong interpersonal and communication skills (both spoken and written)
  • Experience collaborating across departments and with senior leaders and external experts
  • Trained in and knowledgeable regarding Good Clinical Practices, Protection of Human Subjects, HIPAA, and Pharmacovigilance
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