Operation Manager, Drug Safety

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PRIMARY FUNCTION

  • Be accountable for ensuring effective, high quality and efficient management of drug safety operations’ deliverables and strategic planning for functional needs, to ensure compliance with applicable global regulations and guidelines on Pharmacovigilance. 

MAJOR RESPONSIBILITIES, AND DUTIES

  • Provide strategic planning, implementation, and management of Drug Safety Operations activities.
  • Actively monitor the development and post-marketing safety requirements per ICH, China and other international regulations and guidelines and provide insights on the trends of safety requirements.
  • Accountable for identification, development and implementation of pharmacovigilance (PV) process improvements, tools, systems and procedures to enable excellence and consistency in operations.
  • Ensures implementation of standardized processes and procedures (SOP) for Drug Safety Operations activities to ensure PV compliance, including Adverse Event (AE) processing and aggregate reporting.
  • Supervises operations personnel (direct reports, consultants) including mentoring and training.
  • Establishes PV CRO oversight procedures and Key Performance Indicators (KPIs).
  • Ensures that the PV Database supports the functional needs and provides oversight of systems and MedDRA updates in collaboration with the relevant PV CRO.
  • Responsible for timeline management and ensuring global submission of aggregate safety reports and line listings such as DSURs and other aggregate safety reports (e.g.; PSURs/PBRERs) as required.
  • Supports training of functional personnel and other line functions involved in AE collection or processing such as Medical Affairs, sales, medical information, etc.
  • Supports training of functional personnel and other line functions involved in AE collection or processing such as Medical Affairs, sales, medical information, etc.
  • Responsible for the creation, oversight and management of business partner safety data exchange agreements/ pharmacovigilance agreements and other contracts as applicable to ensure compliance with data exchange activity
  • Develops and implements an inspection readiness program with the contribution of other PV and non-PV stakeholders
  • Ensures compliance-related investigations, and development and implementation of corrective actions for deviations from case processing procedures are performed accurately and on time.
  • Participates in regulatory inspections and audits to ensure the quality, integrity and compliance with pharmacovigilance and safety reporting requirements, including authoring of responses to findings relevant to functional area.
  • Provides expert safety/pharmacovigilance guidance to clinical trial project teams and/or external partners to develop procedures and logistics for clinical trials.

 Qualifications

  • Bachelor Degree in Medicine or Pharmacy/Master above preferred
  • Fluent written and spoken English and Chinese
  • Computer Skill: Computer literacy, knowledge with
  • Medical PV knowledge and experience required
  • Good knowledge of ICH, FDA and EMA PV regulatory requirement
  • Good problem solving skills, communication skills and ability to learn new knowledge
  • Good player to work both with a team as well as independently