Position Title:Drug Safety Project Manager/Manager

Position Summary

Accountable for management and service delivery excellence of a range of large, medium or small sized projects being assigned, covering single or multiple Pharmacovigilance (PV) functional activities. Provide leadership and accountability for customer-facing activities and operational service delivery, working cross- functionally, integrating delivery into one seamless and transparent program for customers. Collaborate to implement strategic initiatives and ensure consistency.

Key Responsibilities

Manage customer deliverables for assigned projects and programs.

  • Manage customer interface and communication for assigned projects and programs; Tactical, day-to-day execution of projects, and customer-facing leadership at project and program level. Responsibilities include project planning (timelines, deliverables), scope management, quality management, resource coordination, etc.
  • Provide hands-on support to the service delivery.
  • Liaise between internal and external customer and Safety Service Delivery Team members.
  • Support the profitability tracking and analysis for assigned project and programs.
  • Drive business growth by improving customer loyalty through enhanced customer relations, service delivery excellence.

  • Facilitate bidding and proposal development as needed; Actively contribute to bidding meetings with internal and external stakeholders.
  • Work with other functional teams to ensure rapid, seamless, tailored responses to customer request and opportunities.
  • Provide project team leadership

  • Keep PV project team current on project developments; Lead PV meetings to review project processes and status.
  • Work closely with Safety Service Delivery Team members to ensure projects and programs are delivered in accordance with customer expectations.
  • Provide oversight of Safety Service Delivery Teams. Perform Case Management (Data Entry, Narrative Creation, Quality Control, etc.), Regulatory Reporting (Submission to authorities, ethic committees, investigators, etc.) as needed.
  • Mentor less experienced or newer staff members. May provide oversight on operational activities and have a sound understanding of project protocol, therapeutic indication, scope of work (SOW) for assigned projects; set up and maintain project files, standards, templates, electronic forums, databases and workflow.
  • Ensure high quality standard, compliance and continuous improvement

  • Oversee and support audits and inspections. Liaise with Quality Assurance and management in the compilation of corrective action plans.
  • Ensure compliance to dMed high quality standards and work with Safety Service Delivery Team members constructively in a matrix framework to achieve project and customer deliverables.
  • Read and acknowledge all necessary SOPs, and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented.
  • Contribute to SOP development and enhancement

  • Education and Key Competency Requirement
    Professional Experience & Education Requirement

  • Bachelor’s degree or educational equivalent in health science, medical science or other directly related field
  • At least 4 years’ experience in Pharmacovigilance and drug safety, or other related field (such as clinical research, medical) in CRO or pharmaceutical company;
  • Project Management experience will be a plus

  • Key Competency Requirement

  • In depth knowledge of applicable global regional and local clinical research regulatory requirement, i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, Standard Operation Procedures.
  • Solid experience and working knowledge of Pharmacovigilance service lines; willingness to increase knowledge across Pharmacovigilance service lines and develop new skills.
  • Strong project management; planning and organizational skills.
  • Effective verbal and written communication skills in Chinese and English, including ability to network and lead teleconferences.
  • Effective collaborative, organizational and delegation skills.
  • Ability to establish and maintain effective working relationships with coworkers, managers and customers.
  • Ability to deliver on multiple projects and manage competing priorities.
  • Proven strong presentation, report writing skills.
  • Independent judgement, negotiating and problem solving skills.
  • Demonstrate capability in personal leadership, conflict management.
  • Apply for the position

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