Pharmacovigilance Officer at Fidson Healthcare Plc

Minimum Educational Requirement: 

• HND or B.Sc. in Sciences, or B.Pharm

Minimum Relevant Work Experience: 

• 1 year

Required Competencies and Work Skills:

• Computer literacy
• Good communication skills
• Strong interpersonal skills
• Ability to work under pressure
• Pharmacovigilance experience

Key Job Roles and Responsibilities:

• Prepare and submit PSURs (Periodic Safety Update Reports).
• Generate and regularly update PSMFs (Pharmacovigilance System Master Files).
• Manage adverse reactions, customer complaints, and generate ICSRs (Individual Case Safety Reports) for Fidson products.
• Develop and maintain Standard Operating Procedures (SOPs) for the Pharmacovigilance Unit.
• Prepare SMPCs (Summary of Product Characteristics) and PILs (Patient Information Leaflets) for Fidson products.
• Implement and monitor Post-Marketing Surveillance activities for the company.
• Document and perform statistical analysis of annual post-market surveillance data.
• Liaise with regulatory authorities on pharmacovigilance matters.
• Engage with hospitals, primary healthcare centres, and other relevant stakeholders on pharmacovigilance activities.
• Conduct product research and literature reviews.
• Examine and review product safety profiles.
• Prepare pharmacovigilance intelligence reports.
• Follow up on pharmacovigilance audits and inspections.
• Perform other ad hoc duties as assigned.