Qualified Person for Pharmacovigilance Officer

1. Drug Safety (core PV oversight)

• Establish and maintain a single-point system for collecting/collating all suspected adverse reaction reports (including from medical reps and CRAs)
• Collect, evaluate, process, and submit Individual Case Safety Reports (ICSRs)
• Prepare and submit Periodic Safety Update Reports (PSURs) as needed
• Manage Risk Management Plans (RMPs)
• Negotiate, implement, and maintain Safety Data Exchange Agreements (SDEAs)
• Implement and maintain the Drug Safety System Database and Master Files, including data reconciliation (including with 3rd parties)
• Conduct required literature searches
• Respond to Health Authority safety queries on Company products
• Contribute to Annual Product Quality Reviews (APQRs)
• Train Company employees on drug safety procedures
• Ensure compliance with jurisdiction-specific drug safety legislation
• Ensure consistency of drug safety processes/procedures and staff training

2. External Stakeholder Relationship Management

• Build and manage relationships with business partners, complying with PVA/SDEA requirements
• Build relationships with Cipla Global and align with Global Drug Safety
• Maintain a strong profile with regulatory authorities and industry bodies to positively influence company perception

3. Cross-Functional Alignment

• Determine how the function can best serve the business
• Measure stakeholder satisfaction/performance and identify improvements
• Ensure adherence to SLAs and performance criteria

4. People Management

• Hire appropriately skilled personnel in line with transformation objectives; maintain competence records and organograms
• Provide and assess training for the DS team
• Ensure PV induction training for new SSA employees
• Keep DS team Job Descriptions current (annual review or on scope change)
• Set SMART objectives for DNA (performance) purposes
• Support ongoing training and career development
• Manage DS team performance (with VP: Head of Quality)
• Ensure HR policy adherence within the team