Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Our approach to R&D
Position Summary :
The key purpose of this role is to support Pharmacovigilance Operations “PV Ops”– ICSR Management in the following activities:
ICSR Management
ICSR Management Monitoring check
Quality and compliance KPI Analysis, Trend Analysis
Root cause Analysis and CAPA
Argus Configuration for new Programs/Studies
ICSR processing
Case Processing Coding Conventions
Local Operating Companies (LOC) Interactions
Functional Vendor Oversight
PAC awareness
Authorisation
Withdrawal of Market
New Market Authorisation
Clinical Trial/Program Interactions for:
Study/Program Set up
Study/ Program Maintenance
Study/ Program Close out
Argus Configuration for Submissions to destinations including
Clinical Operations/CROs
LOCs
Clinical Research Organisations (CROs)
Partners
Regulatory authorities
The position holder is responsible for the above elements in alignment with GSK standards and regulatory timelines whilst driving the implementation of robust processes for successful PV operations activities, including vendor oversight.
Key Responsibilities :
Performs Management monitoring check and ensures the appropriate documentation
Performs Key Performance Indicator (KPI) analysis for Expedited report compliance and Outbound third party compliance
Conducts Trend analysis in alignment with the relevant procedural document and ensure the justifications are documented appropriately.
Investigates the trends identified, minor issues to identify root causes and CAPAs. Collaborates with the relevant stakeholders to collect all required information ensuring accurate root causes and CAPAs are identified.
Contribute to all aspects of case handling activities from case receipt to expedited reporting and collaborate with stakeholders (i.e., the Safety Evaluation and Risk Management (SERM) group, local operating companies (LOCs) and clinical operations/sciences) to ensure that documentation and processes are in place to achieve successful recording and reporting of safety data during the life cycle of a clinical trial and marketed product.
Work across a complex matrix environment to drive high-quality delivery of case management activities that comply with internal standards and external regulatory requirements; where problems or issues are identified, facilitate investigation into root cause and create corrective/preventative actions (CAPAs)
Escalate identified problems or issues to the appropriate Management Personnel with PV Operations
Generate new ideas and proposals for global implementation; contribute to advancement of PV Operations methodology and processes.
Ensures third parties/vendors develop and implement robust processes to support quality-driven organization.
Demonstrate GSK values
Work with relevant teams to ensure accuracy and functionality of – and appropriate access to – websites, collaborative areas/databases and documents that are a key resource for the Global Safety organisation
Provide support for the following: compile agendas, coordinate key meetings, capture and file meeting minutes, document retention and help create meeting materials
Ensure the smooth running of meetings, liaise with technical teams as appropriate
Support effective communication within and outside the department by reformatting information provided by subject matter experts
Assist with audit & inspection activities, coordinate the collation of audit request documents - upload and reconcile documents provided against the requests
Maintain an awareness and be an early adopter of new technology to select the most appropriate application for a given purpose
Manage and triage group mailboxes as necessary
Provide technical support for department processes and maintain documentation/repositories as needed
Provide administrative support on new hire onboarding
Assist with process improvement activities
May be Subject Matter Expert/Champion or system business owner in specific areas or systems
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Degree in life sciences or medically related field.
2 - 6 Years of Experience in ICSR.
Knowledge of GSK products and business structure
Knowledge of ICSR submissions with Health agencies and partners
Awareness on investigative methodologies and techniques (e.g., 5 Whys, Fishbone etc)
Project management experience
Ability to map processes and author written standards
Knowledge and experience with pharmacovigilance systems
Familiarity with MS Office tools, document management systems
Excellent organisational skills and attention to detail
Ability and willingness to proactively communicate with stakeholders to understand needs and be responsive to requests
Ability to effectively handle and appropriately escalate issues in a timely manner based on risk
Awareness of PV processes and ability to develop, document, communicate and oversee processes
Awareness of process improvement techniques and ability to analyse performance metrics to drive continuous improvement
Preferred knowledge of other related disciplines e.g. management, communications, information management
Demonstrated ability to work independently, in a flexible manner and adjust to change. Familiarity with medical/scientific terminology desirable
Working knowledge of PV or previous experience of PV or data management.
Why GSK?
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Continuously looking for opportunities to learn, build skills and share learning.
Sustaining energy and well-being.
Building strong relationships and collaboration, honest and open conversations.
Budgeting and cost-consciousness.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Inclusion at GSK:
As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.
Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.
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