Pharmacovigilance Associate Director/Director

Beijing or Shanghai, China

Responsibilities:

  • Local based PV expert, and responsible for the safety reporting and case review/evaluation for assigned clinical projects, input for design and successful implementation of medical safety strategies for assets, by authoring and reviewing medical-scientific reports, safety analyses and evaluations and ensuring cross-functional implementation and follow-up with the appropriate stakeholders in and outside Clinical Development and Sironax.
  • Responsible and accountable for conducting medical safety activities including supporting IND/NDA submission activities in leading LRMP development in close collaboration and communication with relevant stakeholders, and Clinical project team. Additional responsibilities and accountabilities include review of clinical safety related dossier, projects safety management plan, and other safety related documents, Chinese case review by demands including SAE, SUSUR etc PV reporting materials.
  • Faciliate the internal and external stakeholders on Projects PV reporting and review process, and eTMF management related, by close cross functions engagement.

Required Qualifications

  • Master’s degree in clinical medicine or clinical pharmacology required
  • Minimum of 8 years of experience in the pharmaceutical industry with at least 5 years on PV function;
  • Direct exposure to pharmacovigilance functions, additional regulatory and/or clinical development experience is preferred.
  • Understanding of safety regulations for both marketed and investigational products, and knowledge of regional and global authority requirements, including ICH, and other applicable requirements, able to influence decisions relating to patient safety and assessment of benefit-risk.
  • Sound scientific knowledge to evaluate and interpret clinical and scientific data and to communicate with both internal and external stakeholders.
  • Specific working knowledge and experience in medical safety functions, including risk, signal management and periodic reports.
  • Excellent communication and presentation skills in English (both written and spoken)
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