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