Position Title:Associate Manager, Safety Operation & Reporting
Department:Drug Safety & Pharmacovigilance
Location:Shanghai / Wuhan

Position Summary

Accountable for project management and service delivery excellence of the projects being assigned, covering single or multiple Drug Safety & Pharmacovigilance (PV) functional activities within the projects. 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. Team Lead level accountable for people management within Safety Operation & Reporting Team in conjunction with department’s objectives.

Key Responsibilities

Manage customer deliverables for assigned projects/programs

· Manage customer interface and communication for assigned projects/programs; Tactical, day-to-day execution of projects, and customer-facing leadership at project/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/programs.

Drive business growth by improving customer loyalty through enhanced customer relations, service delivery excellence

· Facilitate bidding defenses and proposal development as needed.

· Actively contribute at bidding defense meetings with internal and external stakeholders.

· Work with other functional teams to ensure rapid, seamless, tailored responses to 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/programs are delivered in accordance with customer expectations.

· May provide an oversight role 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 for assigned projects. Liaise with Quality Assurance staff 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 dMed standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented.

· Contribute to SOP development and enhancement.

Team Management

· Team Lead level oversees development of direct reports by setting goals, conducting performance reviews, evaluating and monitoring training needs, creating development plans, mentoring, and coaching.

· Set priorities and schedule activities of departmental resources, implement company and project objectives, and create alternative solutions to address business and operational challenges.

Managerial responsibilities including employee recruitment, professional development, trainings, utilization, performance review, and timesheet review and approval.

Education and Key Competency Requirements

Professional Experience and Education Requirement

· Bachelor’s degree, in Life-science or Pharmaceutical discipline is preferred.

· Healthcare specialty is a plus.

· At least 5 years’ experience in drug safety and pharmacovigilance.

· Project management experience is 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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