Job Description
Minimum Educational Requirement:
- HND, BSc in Sciences, B.Pharm
Current Holder’s Qualification(s):(Not specified)
Minimum Relevant Work Experience:
Required Competency and Work Skills:
- Computer literacy
- Good communication skills
- Good interpersonal skills
- Ability to work under pressure
- Pharmacovigilance experience
Key Job Roles:
- Preparation and submission of PSURs (Periodic Safety Update Reports)
- Generation and regular updates of PSMFs (Pharmacovigilance System Master Files)
- Management of adverse reactions, customer complaints, and generation of ICSRs (Individual Case Safety Reports) for Fidson products
- Development and maintenance of Standard Operating Procedures (SOPs) for the Pharmacovigilance Unit
- Preparation of SMPC (Summary of Product Characteristics) and PIL (Patient Information Leaflet) for Fidson products
- Implementation and monitoring of post-marketing surveillance exercises for the company
- Documentation and statistical analysis of annual post-market surveillance data
- Liaison with regulatory authorities on pharmacovigilance activities
- Liaison with hospitals, primary healthcare centers, etc., on pharmacovigilance activities
- Product research and literature review
- Product (safety) examination and review
- Pharmacovigilance intelligence reporting
- Follow-up on pharmacovigilance audits and inspections
- Any other ad-hoc duties as required