Pharmacovigilance Officer

About the role

The Pharmacovigilance Officer will lead drug safety activities, ensuring compliance with regulatory requirements and supporting the safety of Cipla's products in Kenya.

Key responsibilities

• Establish and maintain a single-point system for collecting all suspected adverse reaction reports.
• Collect, evaluate, process, and submit Individual Case Safety Reports (ICSRs) and Periodic Safety Update Reports (PSURs).
• Manage Risk Management Plans (RMPs) and negotiate Safety Data Exchange Agreements (SDEAs).
• Implement and maintain the Drug Safety System Database and master files, including data reconciliation.
• Conduct literature searches and respond to health authority safety queries.
• Contribute to Annual Product Quality Reviews and train employees on drug safety procedures.
• Build and manage relationships with business partners, Cipla Global, regulatory authorities, and industry bodies.
• Hire, train, and manage the drug safety team, setting objectives and ensuring HR policy adherence.

Required profile

• Experience in pharmacovigilance or drug safety, preferably within a pharmaceutical environment.
• Knowledge of jurisdiction-specific drug safety legislation and regulatory expectations.
• Strong analytical and communication skills to interact with internal and external stakeholders.

Required skills

• Drug safety system database management
• Adverse event reporting (ICSR, PSUR)
• Risk Management Plan development