About this role
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