Senior Specialist ICSR Management Vacancy at GSK Bengaluru
Apply for GSK Senior Specialist ICSR Management role in Bengaluru. Openings for experienced pharma safety professionals. Apply online now!
At GSK, we unite science, technology, and talent to get ahead of disease together. As one of the world’s leading biopharma companies, GSK is dedicated to improving health outcomes through innovative medicines and vaccines. This role offers the chance to contribute to global pharmacovigilance and clinical safety operations while building a rewarding career in Bengaluru.
Company Overview
GSK (GlaxoSmithKline) is a global biopharmaceutical leader with a mission to positively impact the health of 2.5 billion people by the end of this decade. The company focuses on four therapeutic areas: respiratory, immunology and inflammation, oncology, HIV, and infectious diseases. GSK is driven by innovation, science-backed research, and a strong culture that prioritizes patients, accountability, and ethical practices.
Job Role & Responsibilities
As a Senior Specialist, ICSR Management, you will play a pivotal role in pharmacovigilance and case management activities. Key responsibilities include:
- Managing all aspects of case handling activities from receipt to expedited reporting.
- Collaborating with Safety Evaluation and Risk Management (SERM), local operating companies (LOCs), and clinical operations teams.
- Ensuring compliance with global pharmacovigilance regulations, GCP, GVP, and CTR.
- Driving high-quality delivery in case management and creating CAPAs for identified issues.
- Supporting study/program set-up, maintenance, and close-out activities.
- Reviewing Safety Management Plans, Data Management Plans, and study documents.
- Overseeing Argus configuration for programs, studies, and regulatory submissions.
- Conducting training and oversight of third-party vendors to ensure compliance.
- Reviewing adverse event and serious adverse event reporting.
- Monitoring KPIs to identify risks and implement mitigation strategies.
- Managing PV Operations mailboxes and providing timely responses to spontaneous and clinical trial queries.
Eligibility / Qualifications
Education Background:
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, Pharmacology, or related fields.
Required Skills & Knowledge:
- In-depth knowledge of pharmacovigilance regulations, clinical safety documentation, and adverse event reporting.
- Strong understanding of medical and drug terminology.
- Experience with safety databases (Argus preferred).
- Knowledge of Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and Clinical Trial Regulations (CTR).
- Proven prioritization, problem-solving, and communication skills.
Experience Required:
- Prior experience in ICSR Management, Pharmacovigilance Operations, or Drug Safety.
- Experience in case processing, vendor oversight, and regulatory interactions is highly desirable.
Location & Salary
- Location: Luxor North Tower, Bengaluru, India
- Job Type: Full-time, Medical & Clinical
- Salary: Competitive base salary + annual performance bonus
- Benefits: Healthcare & wellbeing programs, learning and development opportunities, flexible working options, employee recognition programs
- Job Posting ID: 427110
- Posted Date: September 8, 2025
Application Process
Interested candidates are encouraged to apply directly through the official GSK careers portal. Apply as soon as possible to maximize your chance of consideration.
FAQs
1. What does ICSR stand for?
ICSR stands for Individual Case Safety Report, which includes safety and adverse event data during clinical trials and post-marketing surveillance.
2. Who is eligible for this role?
Candidates with degrees in life sciences, pharmacy, or biotechnology, along with experience in pharmacovigilance or case management.
3. What tools are used in this role?
Knowledge of Argus safety database and familiarity with regulatory submission platforms is preferred.
4. What benefits does GSK offer?
Competitive salary, annual bonus, healthcare, wellbeing programs, career growth opportunities, and flexible working arrangements.
5. How can I apply?
Apply through the official GSK Careers Website.
Call to Action
Join GSK and be part of a purpose-driven team that transforms healthcare globally. Apply today and take your career in pharmacovigilance to the next level.
Apply before the position closes to secure your opportunity!
Job Summary Table
| Company | GSK (GlaxoSmithKline) |
|---|---|
| Vacancies | Senior Specialist, ICSR Management |
| Required Education | Bachelor’s/Master’s in Life Sciences, Pharmacy, Biotechnology, Pharmacology |
| Experience | ICSR Management, Pharmacovigilance, Drug Safety, Case Processing |
| Location | Bengaluru, India |
To apply for this job please visit jobs.gsk.com.