Nairobi Qualified Person For Pharmacovigilance Officer Nair

Job description

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