Remote- und Homeoffice Jobs in -collegeville ∙ Seite 1

Position Purpose

• Support PV Licensing systems and processes; oversee data quality and conformity in SDEA tracking systems.
• Management of PV Licensing shared storage locations (e.g., SharePoint, Network drives, etc.)
• Participate in system development and maintenance; understand strategic development of PV Licensing system with regards to potential future implementation.
• Support SDEA development and implementation processes.
• Support reporting outputs from PV Licensing systems, including but not limited to ad hoc status reports, quality management outputs, pharmacovigilance system master file annex.
• Serves as key resource within area of expertise.

Primary Responsibilities

• Support PV Licensing team in developing efficient processes surrounding SDEA activities; uses established procedures to perform assigned tasks.
• Maintains PV Licensing systems as appropriate and participates in enhancement projects.
• Acts as a designated Subject Matter Expert for technical systems related to PV Licensing. Has knowledge of the principles and concepts of the discipline; Applies technical skills to achieve assigned tasks; Contributes to the completion of routine team related tasks; uses established procedures and assists with development of new procedures relevant to the systems used as appropriate.
• Is responsible for certain team deliverables: e.g., Responsible for creation and generation of reports and metrics from PV Licensing systems.
• Contributes to the completion of project tasks, may lead certain projects with supervision, organizes own work to meet project deadlines.
• Provide data management support of PV Licensing activities and systems, including managing Quality Events, Data Quality, Quality Checks, Quality Review, Contact List maintenance and End-to-end quality.
• Supports maintenance of PV Licensing documents in designated central repositories (e.g. GDMS and PV Licensing Shared Drive).
• Develop relationships with functional lines related to SDEA activities. Communicates straightforward information, asks questions and checks for understanding. May use existing communication materials to explain information and persuade others in straightforward situations.
• Represent PV Licensing on identified operational forums as needed; participates in planning and logistics meetings with department management.
• Oversee and import information into repositories for document storage and sharing (e.g. SharePoint, GDMS, PV Licensing repository).
• Participates and contributes as a team member.
• May develop identified PV Licensing team presentations.
• Proactively identifies and resolves potential problems with basic complexity.
• Completes assignments independently and selects the most appropriate method to do so
• Handles confidential information appropriately.
• Manages project activities as assigned by PV Licensing Team Lead; exercises judgement to complete assigned tasks.
• Provide support for PV Licensing Leads on operational and administrative issues; participate in special projects as required.
• Responsible for developing, implementing and using standardized working practices within the PV Licensing team, based on global standards and processes, to ensure optimal usage and tracking of information within PV Licensing team.

Technical Skill Requirements

• Has fundamental and specialized knowledge and skills in procedures, techniques, tools, materials and or equipment needed for the position.
• Contributes to the completion of projects/work groups/department tasks.
• Identifies and implements required delivery and process improvement.
• Fully trained in MS Office Applications.
• Knowledge and understanding of data management systems and other applications as required – Internet Explorer, Visio, WebEx, AV equipment, and telecommunication technology.

Qualifications

• Bachelor’s degree (preferably in a scientific or technical field) and relevant 3+ years industry experience.
• Previous experience within, or close interaction with, Safety and/or Regulatory functions within a pharmaceutical company or Clinical development functions in order to have a thorough understanding of operational requirements.
• Experience with resource management, administrative capabilities, MS Office computer software, Audio and Video equipment, and telecommunication technology required.
• Strong communication skills both verbal and written and strong organizational and project management skills required.
• Detail orientated.
• Demonstrated success in process development and improvement.
• Ability to develop cross functional relationships at all levels.
• Ability to adapt to changing priorities managing several projects at a time.

 
Work Location Assignment:  This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week or more as needed.

Relocation assistance may be available based on business needs and/or eligibility.