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
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