Pharmacovigilance Officer
Job type
Full Time
Qualification
BA/BSc/HND
Location
Nairobi
Deadline
Not specified
Job description & requirements
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
Similar jobs
Executive Presentation & Strategic Document Specialist
Sheer Logic
Our client, a leading multinational organisation, is seeking an experienced Executive Presentation & Strategic Document Specialist for a short-term assignment. The successful candidate will be responsible for transforming business insights, data and strategic inputs into a concise, compelling and visually impactful executive presentation suitable for senior leadership and Executive Vice President-level review. KEY RESPONSIBILITIES Develop the overall storyline, structure and flow of the strategic presentation. Synthesise commercial, market, category, channel, shopper and financial inputs into clear and compelling executive messages. Develop a high-quality PowerPoint presentation in
Planning Officer[2] - An- Scale -kmtc 8 - 2 Posts
Kenya Medical Training College KMTC
Duties and responsibilities at this level will involve implementing College strategy and planning policies, procedures, systems, standards and guidelines; participating in the preparation of enterprise production cost structure guidelines for budget preparation; implementing the College’s Strategic Plan; implementing strategies on improvement of performance; collecting data on college programmes, activities and projects; participating in the monitoring and evaluation of performance; and compiling supporting documents for performance reporting. For appointment to this level a candidate must have: Bachelor’s degree in any of the following disciplines: - Economics, Statistics, Business, Quali
Regional Coordinator - Coast Region
Fred Hollows Foundation
THE OPPORTUNITY The Regional Coordinator (RC) is the area programme manager for Kenya’s Coast Region and a senior member of the Kenya Country Office. The role leads the planning, coordination and delivery of The Fred Hollows Foundation’s integrated eye health programme across Mombasa, Taita Taveta, Kilifi and Kwale counties, including partner private eye hospitals. In line with The Foundation’s strategy, the coordinator works with governments and other stakeholders to improve eye care services, strengthen the workforce, support data-informed decisions, enhance sector coordination and advance eye health as a social and economic priority. The RC oversees the day-to-day work of a multid