421249 Associate Director ICSR management PV Operations (Open)

Job Summary

The key purpose of this role is to support Pharmacovigilance Operations (PV Ops) in ICSR Management. The position holder will be responsible for various activities related to ICSR management, ensuring alignment with organizational standards and regulatory timelines while driving the implementation of robust processes for successful PV operations activities, including vendor oversight.

Responsibilities

• Manage ICSR processing and ensure adherence to coding conventions.
• Configure Argus for new programs and studies, including submissions to regulatory authorities, partners, Clinical Research Organizations (CROs), and Local Operating Companies (LOCs).
• Oversee functional vendor interactions and ensure compliance with new market authorizations and withdrawals.
• Facilitate clinical trial/program interactions, including study/program setup, maintenance, and closeout.
• Maintain effective communication with Local Operating Companies (LOC) and ensure alignment with organizational standards.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, or a related field.
• Strong knowledge of Pharmacovigilance and ICSR management processes.
• Proficiency in Argus and case processing coding conventions.
• Excellent communication and interpersonal skills.
• Strong organizational and project management abilities.
• Familiarity with regulatory requirements and standards in pharmacovigilance.
• Experience in vendor oversight and management.

Preferred Skills

• Advanced degree (e.g., Master's, PhD) in a relevant field.
• Experience with clinical trial management and interactions with CROs.
• Knowledge of global regulatory requirements for pharmacovigilance.

Experience

• Minimum of 5-7 years of experience in Pharmacovigilance operations, specifically in ICSR management and vendor oversight.

Environment

• The position is based in Bengaluru, Luxor North Tower, and follows a hybrid work mode, combining both in-office and remote work.

Salary

• Estimated salary range: ₹8,500,000.

Growth Opportunities

• Opportunities for career advancement within the organization, including potential leadership roles in Pharmacovigilance and related fields.