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Associate Director, IT Pharmacovigilance Systems

Posted on Apr 6, 2021 by BeiGene, Ltd.

Cambridge, MA 02138
Research
Immediate Start
Annual Salary
Full-Time


The Associate Director, Pharmacovigilance Systems role is a key leadership position within the BeiGene IT organization. The primary goal of this position is to be the strategic IT partner to the global Pharmacovigilance (Global Patient Safety) business unit at BeiGene. This global function, along with the key stakeholders, will help define business objectives, engineer technical solutions, and build technical roadmaps to support all the requirements and initiatives of the global business units. In addition, this position will work to manage the portfolio of applications and solutions used by the business to ensure overall compliance, effectiveness, efficiency and meeting all business requirements while also adhering to the overall BeiGene IT framework. This individual is also responsible for planning, structuring, and monitoring system implementation, as well as testing and change control procedures for relevant PV/Drug Safety systems.


The ideal candidate should bring experience working in Cloud/SaaS and IaaS environments primarily in the PV/Drug Safety space with the ability to manage multiple projects across different functions for a global, geographically diverse environment. The candidate should also be experienced at running IT projects as a business from a strategy, technology, security, process, finance, and people management standpoint. The individual must be able to provide technical expertise and have system administration experience. This individual will apply proven communication, analytical, and problem-solving skills to help maximize the benefit of enterprise IT system investments.


Essential Functions of the job:


Partner with stakeholders and SMEs to develop business cases that justify and prioritize initiatives while adhering to overall business plan.
Develop short- and long-term plans in alignment with and support for global patient safety business unit strategies and goals, business plans, and operating requirements and efficiencies
Define requirements, goals & objectives, strategies, critical success factors, project barriers, resources, etc. with the goal of delivering solutions that meets all business requirements, in a timely and compliant manner.
Act as technical and/or project lead in the planning, design, configuration, and deployment of new systems, and enhancements to existing enterprise wide computerized systems primarily for the Global Patient Safety (PV/Drug Safety) team.
Collaborate with the project team in the planning, design, configuration, and deployment of new applications, and enhancements to existing applications and platforms including Argus, Veeva, Cognos, PowerBI, and DataMart/Data Warehouse.
Act as the business relationship manager (BRM) for the global Patient Safety (PV/Drug Safety) team.
Partner with stakeholders in the design, configuration and implement data integration between multiple enterprise systems along with future strategy towards enterprise integration platform
Collaborate with IT Infrastructure Engineering, Operations, Security/Compliance, QA, Service Desk and applicable vendor team to properly assess project complexity, compliance requirements and technical requirements
Liaise with computer system vendors, IT partners, Quality, Validation and the business to coordinate implementation activities
Analyze user enhancement requests to deliver solutions focused on establishing and improving business processes, addressing process gaps, and enabling automation and growth of the organization.
Manage projects to ensure appropriate resources are allocated and timelines are met
Manage consultants to ensure projects and/or required system administration activities are addressed adequately.
Analyze user enhancement requests to deliver solutions focused on establishing and improving business processes, addressing process gaps, and enabling automation and growth of the organization.
As the IT owner of PV systems, ensure the overall health and stability of the deployed platforms and coordinate escalation as necessary when issues arise.


Qualifications:


7+ years direct experience managing Drug Safety/PV applications and/or systems management in a pharmaceutical or medical device industry especially Argus and Veeva
5+ years direct experience managing enterprise applications and/or systems management
Proven experience in overseeing the direction, planning, installation and implementation of software solutions. Direct, hands-on experience with server administration tools.
5+ years of proven leadership at a senior level
5+ experience in working within GxP or regulated environment and within an SDLC framework.
Proven experience in overseeing the direction, planning, installation, implementation, and maintenance of software solutions especially in the SaaS/Hybrid cloud environment
Good working knowledge of O365 and Active Directory technology and schema
Networking and general IT security knowledge
Working knowledge of IaaS (Amazon Web Services, Azure) PaaS and SaaS architectures and technology options a plus


Other Qualifications:


Excellent project management skills and/or substantial exposure to project-based work structures.
Extensive experience working with drug safety technologies and platforms.
Strong customer-service orientation.
Ability to communicate ideas in both technical and user-friendly language.
Highly self-motivated and directed.
Ability to effectively prioritize and execute tasks in a high-pressure environment. Experience working in a team-oriented, collaborative environment.
Strong knowledge of authoring computer system validation documentation
Strong analytics and strategic thinking skills with attention to detail


Education Required:


Bachelor's Degree in Information Technology or related field/experiences


Supervisory Responsibilities:


This position may include managing staff; coaching and mentoring of junior staff with training/orientation/qualification and development plan when required.


Travel:


Competencies:


Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically in accordance with BeiGene's Code of Business Conduct and Ethics, policies and procedures.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Completes administrative tasks correctly and on time; Follows instructions and responds to management direction.
Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations; Writes clearly and informatively; Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyones efforts to succeed; Contributes to building a positive team spirit; Shares expertise with others.
Adaptability - Able to adapt to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability - Follows instructions and responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management - Communicates changes and progress; Completes projects on time and within budget.




Reference: 1152691052

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