Lead Safety Data Specialist Job

Date: May 2, 2019

Location: Beijing, 11, CN

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Requisition ID: CLI008423

Under the direction of a manager, the Lead Safety Data Specialist (Lead SDS) is responsible for analyzing, triaging and processing of all adverse experience information received for investigational and marketed products, according to standard operating procedures (SOPs) for further reporting to worldwide regulatory agencies by Global Pharmacovigilance. In addition, the Lead SDS collaborates with other staff within the organization, as well as cross-functionally, and is accountable for the quality and timely execution of processes and procedures to guarantee Global Pharmacovigilance Case Management (GPVCM) deliverables.
Global Pharmacovigilance Case Management (GPVCM) - 100%

Individuals with wide experience as a Trainer, Liaison, PV lead, Subject Matter Expert (SME) and Process Lead:

Core activities include, but are not limited to:
• Perform all core responsibilities of a Senior Safety Data Specialist role as needed.
• Lead and ensure development, effective implementation and continuous optimization of the basic and PV specific training and mentoring plans for the team. Ensure alignment and continuous improvement of global training processes with minimal guidance from PV management.
• Serve as a GPVCM expert, to effectively interact and communicate with customers and stakeholders both internal and external to GPVCM when needed in resolution of critical complex issues. Lead and actively participate in GPVCM global Lead/Liaison network to discuss and create solutions on critical process issues and inconsistencies, to standardize and optimize processes at global level of the operations.
• Continually identify opportunities of business and/or operational process improvement to increase efficiency and effectiveness, lead planning, execution and communication of changes locally and globally as appropriate.
• Support people or team to work in challenging scenarios, identify and communicate critical risks and complex unresolved issues with well-developed mitigation plans and resolution proposals to management or Global Safety SME as a GPVCM representative.
• Lead or serve as a SME in the cross-functional strategic projects.
• Support managers to create and execute development strategies for the Data Management Center (DMC) staff based on operational and business needs.
• Assist managers to prepare and respond to Regulatory Agency Inspections as well as internal and external audits.
• Assist managers with the development and implementation of departmental procedures and education programs.
• Based on his/her experience, be able to support any role or task in the team when needed.
• Act as manager back up for specific tasks or projects when needed.

Qualifications

Education:
• A bachelor's degree and above, preferably in medicine, pharmacy, nursing or biological sciences.

Skills:
• At least four years’ experience in Pharmacovigilance.
• Exceptional organizational, time management, analytical and problem solving skills.
• Excellent overall communication skills with advanced oral and written English skills.
• Advanced computer skills.
• Extensive knowledge of applicable regulations and policies.
• Able to work under high pressure in a changing and ambiguous environment with flexibility.
• Self-motivated, strong sense of responsibility and accountability.
• Excellent planning, project management and decision making capabilities.
• Customer focus with strong sense of urgency.
• Demonstrated leadership with excellent communication, interpersonal and negotiation skills.
• Ability to work independently, accept and act with appropriate accountability with minimal guidance by a manager.




Job: Clinical Data Management
Other Locations:
Employee Status: Regular
Travel:
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Database, Safety, Law, Pharmacovigilance, Pharmacy, Technology, Service, Legal, Healthcare

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