Kusum healthcare Hiring in Pharmacovigilance

Kusum is a reputed pharmaceutical company known for its high-quality healthcare products and services. With a strong commitment to safety and compliance, Kusum ensures its operations align with global standards, particularly in the field of pharmacovigilance. Joining Kusum means contributing to a mission of improving global health through innovation and dedication.

Key Responsibilities

As a Pharmacovigilance Executive, your role will involve critical activities aimed at ensuring the safety and efficacy of pharmaceutical products. Here’s a detailed overview of your responsibilities:

1. Global Literature Surveillance:
   • Monitoring global literature for safety data on the company’s products.
2. ICSR Case Processing:
   • Handling individual case safety reports (ICSR) including data entry, quality control, and regulatory reporting.
3. Database Updates:
   • Keeping the pharmacovigilance database updated with product registration details.
4. Report Preparation:
   • Developing Periodic Safety Update Reports (PSUR) and Risk Management Plans (RMP).
5. Signal Management:
   • Performing and updating the signal management system to identify potential safety concerns.
6. Documentation:
   • Creating and revising product-related documents like SmPC, PIL, inserts, monographs, and presentations.
7. SOP Management:
   • Preparing and revising departmental Standard Operating Procedures (SOPs), Work Instructions (WIs), and manuals.
8. Audit Readiness:
   • Participating in audits and inspections to ensure compliance with regulatory requirements.
9. Interdepartmental Communication:
   • Coordinating with other departments for necessary documents and data.
10. Managerial Support:

• Assisting the manager or HOD with trackers and monthly presentations.

11. Additional Tasks:

• Handling any other assignments as directed by the Manager/HOD.

Qualifications Required

To excel in this role, candidates should meet the following requirements:

• Education:
  • A bachelor’s or master’s degree in pharmacy, life sciences, or a related field.
• Experience:
  • Minimum of 3 years of relevant experience in pharmacovigilance.

Skills and Competencies

The ideal candidate should possess:

• Strong knowledge of pharmacovigilance principles and guidelines.
• Proficiency in ICSR case processing and regulatory reporting.
• Excellent documentation and report preparation skills.
• Familiarity with signal management and safety databases.
• Detail-oriented with strong organizational skills.
• Effective communication and teamwork abilities.
• Readiness to participate in audits and inspections.

Application Link