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
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
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
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
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