Basic qualifications:

• Years of experience: 2 to 4 Years
• Grade: 9B
• Skill Set: Training related activities, capability development.
• Not looking for someone with PV or Science background.
• MS Office, New Tools, MS Visio
• work in regulatory environment
• Power Point and Video Creating
• Nice to have tool experience: Synthesia, Collosyan
• Excellent Communication skill Written and Verbal  
• experience using an LMS (Don't look for LMS Candidates)
• Learning Agility, Innovating Thinking

Key Responsibilities ​::

Core BSP Accountabilities

• Contribute to creation or development of BSP processes and written standards
• Collaborate with stakeholders (e.g. PV Operations, the Safety Evaluation and Risk Management (SERM) group, local operating companies (LOCs), and Clinical Operations/Sciences/Development) to ensure that documentation and processes are in place to achieve successful recording, reporting, analysis and signal detection of safety data during the life cycle of a clinical trial and marketed product
• Work across a complex matrix environment to ensure compliance with internal standards and external regulatory requirements
• Where process or training issues are identified, facilitate investigation into root cause, creation of corrective/preventative actions (CAPAs), and support with remediation of process/training needs
• Review and maintain oversight of BSP training materials
• Work with content owners and experts to prepare internal and external presentations as required
• Implement changes to Global Safety training curriculums in line with current BSP structure and maintain oversight of BSP training aspects
• Manage BSP Optimization mailboxes for responsible workstream and respond to allocated queries in a timely manner.
• Facilitate, where required to assess the impact of changes to Pharmacovigilance regulations and track implementation of changes required
• Track and oversee regulatory enquiries sent to BSP, ensuring appropriate, thorough and timely responses
• Support with archiving, in line with GSK Global Archiving processes, ensuring the successful retrieval of documentation and supporting inspection-readiness
• Where problems or issues are identified, escalate to BSP Manager / Director, as appropriate
• Generate new ideas and proposals for global implementation; contribute to advancement of BSP methodology and optimization of processes.
• Coordinate BSP involvement in audits and inspections
• Demonstrate GSK values

Technical Associate, BSP

• Work with relevant teams to ensure accuracy and functionality of as well as appropriate access to websites and collaborative areas/databases and documents that are a key resource for the Global Safety organization
  • Ensure that robust change control measures are in place
  • Provide document tracking
  • Conduct administrative tasks e.g., filing
  • Format written standards or alternative documents
• Provide support to underpin effective knowledge sharing across the team, including compile agendas, coordinate meetings, capture, and file meeting minutes, support appropriate document retention and provide support to create meeting materials
• Helps to coordinate key meetings, liaise with technical teams as appropriate
• Support effective communication within and outside the department: reformat information provided by subject matter experts to create consistent and visually appealing slides, web pages, etc., in line with corporate branding
• Support training activities: organize training meetings, record training sessions, develop training documentation
• Support audit & inspection activities: scribe audits, coordinate the collation of audit request documents e.g., upload and reconcile documents provided against the requests
• Foster continuous improvement: conduct quality checks, compile and analyze metrics for information management, communication and engagement, and other specified activities, and proactively seek process improvement opportunities
• Manage and triage group mailboxes
• Provide technical support for department processes and maintain documentation/repositories as needed
• Maintain familiarity and may be Subject Matter Expert/Champion or system business owner of systems used in functional area

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

  
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