MICC Manager PV

Role & Responsibilities
• Manage end-to-end MICC (Medical Information & Call Center) operations within Pharmacovigilance
• Oversee PV case intake, triage, and ICSR processing as per global regulatory guidelines
• Ensure compliance with SOPs, SLAs, and global regulatory requirements (FDA, EMA, ICH)
• Review and monitor ICSR cases for quality, accuracy, and timely submissions
• Handle escalations, client communications, and internal stakeholder coordination
• Train, mentor, and supervise MICC team members
• Prepare and present performance metrics, quality reports, and audit documentation
• Support regulatory inspections and audits as required

Qualification
• M.Pharm / Pharm.D / B.Pharm / Life Sciences (relevant qualification preferred)

Experience
• 6–7 years of Pharmacovigilance experience
• Strong exposure to MICC / Call Center PV operations
• Experience in team management and stakeholder coordination

Skills
• In-depth knowledge of ICSR processing and MedDRA coding
• Hands-on experience with global safety databases
• Strong understanding of FDA, EMA, and ICH regulatory guidelines
• Leadership and team supervision skills
• Excellent communication and client management abilities
• Ability to work in night shift (9:00 PM – 6:00 AM IST)

About the Company
Mitocon Biopharma operates within the pharmacovigilance and drug safety domain, delivering MICC and global PV operations support to pharmaceutical clients. The organization provides leadership opportunities, exposure to international regulatory standards, and a dynamic work environment focused on quality, compliance, and operational excellence in Hyderabad.