Kusum is a reputed pharmaceutical company with a strong presence in the healthcare sector. With a rating of 3.9/5 (based on 255 reviews), the company is known for its commitment to quality and compliance in Pharmacovigilance and Medical Affairs.

Job Highlights

✔ Experience in Pharmacovigilance & Quality Management Systems
✔ Knowledge of SDEAs & Safety Databases
✔ Global Literature Surveillance & AE/ADR Management
✔ Preparation of PSURs, RMPs, SmPC, PIL, and other regulatory documents
✔ Support in Pharmacovigilance Audits & Inspections
✔ Deputy QPPV Role Opportunity

Job Description

Roles & Responsibilities:

• Conduct Global Literature Surveillance for company products.
• Prepare and review product-related documents (SmPC, PIL, Inserts, PSURs, RMPs).
• Handle Adverse Events (AEs) & Adverse Drug Reactions (ADRs).
• Manage Safety Database and ensure compliance.
• Assist in drafting Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Agreements.
• Support Pharmacovigilance Quality Management System (QMS).
• Help in developing new Pharmacovigilance strategies.
• Update SOPs & Working Instructions for the department.
• Coordinate with the PV team for data collection and reporting.
• Perform signal management activities.
• Conduct Pharmacovigilance training for employees.
• Ensure audit & inspection readiness.
• Act as Deputy QPPV in the absence of the Global QPPV.
• Perform other tasks assigned by the HOD.

How to Apply

Application Link