Years of Experience: 9+ years
Skill Set / Exposure: ICSR, Case processing, PV, Clinical background, Data Management
Location: Bangalore (Hybrid Mode (3-4 days office)
Job Description:
Job Purpose:
- The key purpose of this role is to support Pharmacovigilance Operations “PV Ops”– ICSR Management in the following activities.
ICSR Management:
- Argus Configuration for new Programs/Studies
- ICSR processing
- Case Processing Coding Conventions
- Local Operating Companies (LOC) Interactions
Functional Vendor Oversight:
- New Market Authorization
- Withdrawal of Market
- Authorization
- Ongoing Pharmacovigilance activities
- Quality processes
Compliance:
- Clinical Trial/Program Interactions for
- Study/Program Set up.
- Study/ Program Maintenance
- Study/ Program Close out.
- Argus Configuration for Submissions to destinations including.
- Regulatory authorities
- Partners
- Clinical Research Organisations (CROs)
- LOCs
- Clinical Operations/CROs
- Support continuous process improvement across ICSR management though management monitoring and other activities.
- 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 (suggested no more than 10 bullet points):
Core Accountabilities (applicable to all)
- 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. May include independent quality review of cases processed by vendor.
- Monitor Key Performance Indicators (KPIs) ensuring compliance and quality thresholds are met and address any metrics indicating missed KPIs
- Input into Root Cause Analysis (RCA) and corrective/preventive action (CAPA) formation/effectiveness checks.
- 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)
- Support Inspections/Audits (led by Pharmacovigilance Quality Assurance (PVQA of Central/LOC/Vendor processes)/ LP Audits/ Regulatory Inspections (Central and LOC)/ Notified Body Audits
- Confirm appropriate management monitoring activities are complete.
- 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.
Principal Scientist, PV Operations - ICSR Management:
- Support Scientists with enhancement of knowledge and skills for ICSR Management activities including quality and compliance activities.
- Leads and oversees Clinical Trial and/or post-Marketed study (PMS) related activities e.g. protocol review, Safety Management Plan review, study/program set-up, reconciliation, end of study unblinding, etc.; supports case management activities for spontaneous event reports.
- Acts as a global PV Operations Leader for process discussions, including queries on strategy/policy related decisions; authors or provides significant input into the development of written standards.
- Lead investigation into root cause and ensure appropriate creation and documentation of corrective/preventative actions (CAPAs)
- Generates new ideas and proposals for global implementation; contributes to advancement of ICSR management/ program/clinical trial set up/maintenance methodology and processes.
- Prioritize work and time management, in line with business needs.
Education Requirements (minimum expected):
- Degree in life sciences or medically related field or previous experience equating to educational requirements.
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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