Medifodil Hiring For ICSR/ Aggregate/ PV Quality Assurance
We’re Hiring | Pharmacovigilance Department Leadership Roles
Company: Medifodil Smart Pharma Solutions
Work Mode: Onsite
Location: Kukatpally, Hyderabad
Our company is expanding its Pharmacovigilance team and is looking for experienced professionals across multiple PV leadership roles. We are seeking candidates with strong regulatory knowledge, hands-on expertise, and a quality-driven approach to patient safety.
Open Positions for Managerial Roles
Experience: 10-12 Years Experience
• PV ICSR
• Aggregate Reports
• PV Quality Assurance (QA)
Key Responsibilities (Role-Specific)
1. PV ICSR
• End-to-end ICSR intake, processing, medical review, and regulatory submissions
• Ensure timely reporting in line with global regulatory requirements
• Case quality review, coding (MedDRA/other dictionaries), and narrative oversight
• Team management, training, mentoring, and workload allocation
2. Aggregate Reports
• Preparation and review of PSUR, PBRER, DSUR, and other aggregate safety reports
• Data analysis, benefit–risk evaluation, and contribution to signal management
• Ensure compliance with reporting timelines and global regulatory guidelines
• Coordination with medical writing, biostatistics, cross-functional teams, and clients
• Signal detection, validation, prioritization, and evaluation
• Periodic safety data review and trend analysis
• Documentation of signal assessments and regulatory communication support
• Cross-functional collaboration for risk-minimization activities
3. PV Quality Assurance (QA)
• Oversight of pharmacovigilance systems and process compliance
• SOP development, implementation, and periodic review
• Internal audits, inspection readiness, and CAPA management
• Quality metrics tracking and continuous process improvement
Common Responsibilities (All Roles)
• Ensure adherence to global PV regulations and reporting timelines
• Maintain high-quality standards and audit/inspection readiness
• Coordinate with cross-functional teams, clients, and regulatory authorities
Requirements
• Relevant experience in Pharmacovigilance (ICSR, Aggregate, Signal, or QA)
• Strong understanding of global PV regulations and safety databases
• Excellent communication, leadership, and stakeholder-management skills
📩 Interested candidates may share their resume at: careers@medifodil.com
“Application – (ICSR / Aggregate Reports / QA) Experience”
✨ Join Medifodil and be part of a growing organization committed to excellence in pharmacovigilance and patient safety.
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| Medifodil Hiring For ICSR/ Aggregate/ PV Quality Assurance |
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