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.
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