Pharmacovigilance Officer at Fidson Healthcare Plc

Minimum Educational Requirement:

• HND, BSc in Sciences, B.Pharm

Current Holder’s Qualification(s):(Not specified)

Minimum Relevant Work Experience:

• 1 Year

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