"Project Associate I RA QA Job | ELEXES Medical Consulting Hiring Freshers | Pharma Duniya"

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"Project Associate I RA QA Job | ELEXES Medical Consulting Hiring Freshers | Pharma Duniya." (Project Associate I RA QA Job | ELEXES Medical Consulting Hiring Freshers) Introduction If you are a fresher or early-career professional aiming to build a strong career in Medical Device Regulatory Affairs and Quality Assurance , this opportunity can be a perfect starting point. ELEXES Medical Consulting Pvt. Ltd. has announced hiring for the position of Project Associate I – Regulatory Affairs & Quality Assurance (RA/QA) . This role is specially designed for fresh graduates and candidates with up to 6 months of experience who want hands-on exposure to global medical device regulations , including US FDA, EU MDR, CDSCO, Health Canada , along with ISO 13485 quality systems . The position offers real project experience under expert mentorship, making it ideal for long-term growth in the medical device regulatory domain. About The Company – ELEXES Medical Consulting Pvt. Ltd. EL...

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"Career Opportunity at GSK India – Senior Specialist, ICSR Management"

"GSK Hiring Senior Specialist – ICSR Management in Bengaluru | Pharmacovigilance Jobs India"


GlaxoSmithKline (GSK), a global leader in biopharma, is inviting applications for the role of Senior Specialist – ICSR Management at its Bengaluru office. This opportunity is ideal for experienced professionals in pharmacovigilance, drug safety, and clinical research operations who want to contribute to GSK’s mission of improving the health of 2.5 billion people worldwide.

If you have expertise in ICSR processing, case management, and regulatory safety reporting, this could be the right career move for you.


Key Responsibilities:-

As a Senior Specialist – ICSR Management at GSK, you will:

  • Manage end-to-end case processing – from receipt to expedited reporting.
  • Collaborate with SERM, CROs, LOCs, and clinical teams to ensure compliance.
  • Oversee vendor performance, track KPIs, and manage CAPA (Corrective and Preventive Actions).
  • Support study/program setup, review safety protocols, and ensure reconciliation activities.
  • Assist in Argus safety database configuration for regulatory submissions.
  • Participate in UAT reviews, vendor training, and compliance monitoring.
  • Stay updated on global regulations (ICH GCP, GVP, CTR).
  • Mentor junior associates in ICSR processes and case handling.

Qualifications & Skills Required:-

To qualify for this role, candidates should have:

  • Strong understanding of Good Pharmacovigilance Practice (GVP), Good Clinical Practice (GCP), and Clinical Trial Regulations (CTR).
  • Proven expertise in ICSR processing and safety databases (Argus preferred).
  • Knowledge of medical terminology and case coding conventions.
  • Experience in vendor oversight, KPI monitoring, and process improvement.
  • Excellent communication, time management, and prioritization skills.

Why Join GSK?

Working at GSK offers a unique opportunity to:

  • Be part of a purpose-driven global organization.
  • Gain exposure to international pharmacovigilance operations.
  • Access career growth opportunities and professional development programs.
  • Work in a collaborative and innovative environment focused on patient safety.

How to Apply:-

Interested candidates can apply directly through the official GSK careers portal:
๐Ÿ‘‰ Apply Here


FAQs:-

Q1: What is the location of this job?
This role is based at GSK’s Bengaluru, India office.

Q2: What experience is required for the Senior Specialist role?
Candidates should have strong experience in ICSR processing, pharmacovigilance operations, and safety database management (preferably Argus).

Q3: Is vendor management experience necessary?
Yes, the role involves vendor oversight, KPI monitoring, and escalation management.


๐Ÿ‘‰ This is a great opportunity for professionals in pharmacovigilance and drug safety who want to advance their careers with one of the world’s leading biopharma companies.

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