Principal Scientist Role at GSK For Life Sciences – Apply Now!

Principal Scientist Role at GSK For Life Sciences – Apply Now!

Principal Scientist, PV Operations – ICSR

Bengaluru, India

Medical and Clinical

404995

Job Description

Site Name: Bengaluru Luxor North Tower

Posted Date: Sep 24, 2024

Years of Experience: 9+ years

Skill Set / Exposure:

• ICSR
• Case processing
• PV
• Clinical background
• Data Management

Location: Bangalore (Hybrid Mode, 3-4 days in office)

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, Maintenance, and Closeout
• Argus Configuration for Submissions to:
  • Regulatory authorities
  • Partners
  • Clinical Research Organisations (CROs)
  • LOCs
  • Clinical Operations/CROs

Support continuous process improvement across ICSR management through management monitoring and other activities. The position holder is responsible for these elements in alignment with GSK standards and regulatory timelines, driving the implementation of robust processes for successful PV operations activities, including vendor oversight.

Key Responsibilities:

• Contribute to all aspects of case handling activities from case receipt to expedited reporting and collaborate with stakeholders (Safety Evaluation and Risk Management (SERM) group, LOCs, and clinical operations/sciences) to ensure successful recording and reporting of safety data during clinical trials and marketed products.
• Monitor Key Performance Indicators (KPIs) to ensure compliance and quality thresholds are met; 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; facilitate investigations into root cause and create CAPAs where needed.
• Support Inspections/Audits (led by PVQA of Central/LOC/Vendor processes), LP Audits, Regulatory Inspections (Central and LOC), and Notified Body Audits.
• Confirm appropriate management monitoring activities are complete and escalate identified problems or issues to the appropriate Management Personnel with PV Operations.
• Generate new ideas and proposals for global implementation; contribute to the advancement of PV Operations methodology and processes.
• Ensure third parties/vendors develop and implement robust processes to support a 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.
• Lead and oversee Clinical Trial and/or post-Marketed study (PMS) related activities, such as protocol review, Safety Management Plan review, study/program set-up, reconciliation, and end-of-study unblinding; support case management activities for spontaneous event reports.
• Act as a global PV Operations Leader for process discussions, including strategy/policy-related queries; author or provide significant input into the development of written standards.
• Lead investigations into root cause and ensure appropriate creation and documentation of CAPAs.
• Generate new ideas and proposals for global implementation; contribute to the advancement of ICSR management/program/clinical trial set-up/maintenance methodology and processes.
• Prioritize work and manage time effectively, in line with business needs.

Education Requirements (minimum expected):

• Degree in life sciences or a medically related field, or previous experience equivalent to educational requirements.

Apply for this position here

Keywords: Principal Scientist, PV Operations, ICSR, Pharmacovigilance, Bengaluru. Principal Scientist Role at GSK For Life Sciences – Apply Now! Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook and Instagram.