Senior Specialist – ICSR Management | GSK
Location: Bengaluru, India
Department: Medical and Clinical
Employment Type: Full-Time
Posted Date: 18 Dec 2025
Job ID: 432438
Company Overview:
GSK is a global biopharma company with a mission to improve the health of 2.5 billion people by the end of the decade. By uniting science, technology, and talent, GSK delivers innovative medicines and vaccines across respiratory, immunology, inflammation, oncology, HIV, and infectious diseases. We foster an inclusive and collaborative environment where employees thrive, innovate, and make a meaningful impact on patients worldwide.
Role Overview:
We are seeking a Senior Specialist – ICSR Management to support the full lifecycle of case management activities. This role will oversee the processing, reporting, and quality assurance of Individual Case Safety Reports (ICSRs), collaborating with internal teams, vendors, CROs, and local operating companies (LOCs). The ideal candidate will have deep knowledge of pharmacovigilance regulations, safety databases, and ICSR workflows, along with strong communication and leadership skills to guide and support junior staff.
Key Responsibilities:
Oversee all aspects of case handling from receipt to expedited reporting for clinical trials and marketed products.
Collaborate with stakeholders (SERM, LOCs, clinical operations) to ensure accurate documentation and reporting of safety data.
Manage ICSR processing including coding conventions, Argus configuration, and quality control of cases.
Conduct start-up, maintenance, and close-out activities for studies/programs including review of protocols, contracts, AE/SAE forms, and safety database configuration.
Support vendor oversight and ensure third-party compliance with quality standards and PV methodology.
Assist with training and mentoring Technical Associates on ICSR management processes.
Review and maintain Safety Management Plans (SMP), Data Management Plans (DMP), Protocol Data Entry Guidelines (PDEGs), and UAT outputs for EDC and Safety Databases.
Monitor KPIs from suppliers and quality organizations, identify risks, and escalate issues as needed.
Maintain up-to-date knowledge of local and global regulatory reporting requirements and PV methodologies.
Respond to PV Operations mailboxes, manage spontaneous and clinical trial queries, and ensure timely resolution.
Qualifications and Experience:
Bachelor’s degree in life sciences, pharmacy, medicine, or a related field. Advanced degree preferred.
Minimum 5–7 years of experience in pharmacovigilance, with expertise in ICSR management and PV operations.
Strong knowledge of GCP, CTR, GVP, safety databases (preferably Argus), AE/SAE reporting, and pharmacovigilance regulations.
Proven ability to work in a complex matrix environment, prioritize tasks, and deliver high-quality outcomes.
Experience in vendor oversight and global PV operations is highly desirable.
Skills and Competencies:
In-depth understanding of medical terminology and drug safety principles.
Strong organizational, analytical, and problem-solving skills.
Excellent written and verbal communication skills.
Ability to mentor, train, and support junior staff.
Knowledge of data collection, manipulation, and reporting principles.
What GSK Offers:
Competitive base salary and annual performance bonus.
Flexible working options for most roles.
Learning and career development programs.
Access to healthcare and wellbeing initiatives.
Employee recognition programs and inclusive workplace culture.
Inclusion at GSK:
GSK is committed to inclusion and equal opportunity for all employees. Adjustments during the recruitment process are available for candidates with disabilities or special requirements.
Application Note:
Apply now to join a global leader in pharmacovigilance and clinical safety, contributing to patient-centered innovation and excellence in ICSR management.
Gujarat :
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