Regulatory / Pharmacovigilance Executive

Qualifications

• Must have a Bachelor's Degree in Pharmacy.
• Minimum of 3 years of regulatory affairs experience in the pharmaceutical industry.
• Strong knowledge of pharmaceutical regulations and industry practices.
• Attention to detail and analytical skills.
• Effective communication and teamwork abilities.

Qualifications

• Must have a Bachelor's Degree in Pharmacy.
• Minimum of 3 years of regulatory affairs experience in the pharmaceutical industry.
• Strong knowledge of pharmaceutical regulations and industry practices.
• Attention to detail and analytical skills.
• Effective communication and teamwork abilities.

• Act as the primary contact point for NAFDAC, maintaining a 24-hour presence for regulatory inquiries and reporting.
• Establish and maintain the Company's pharmacovigilance (PV) system, ensuring compliance with regulatory requirements.
• Oversee the content and maintenance of the PV System Master File (PSMF) and ensure its availability to Competent Authorities (CA).
• Monitor safety profiles and emerging safety concerns for authorized medicinal products.
• Prepare Periodic Safety Update Reports (PSURs) for products and submit them to relevant Regulatory Authorities.
• Handle the reporting of Adverse Drug Reactions (ADRs) to NAFDAC promptly.
• Coordinate actions in response to suspected product counterfeiting.
• Manage the destruction of expired and rejected products and items in accordance with regulations.
• Implement and maintain safety reporting processes.
• Prepare and manage safety reports.
• Collaborate with internal functions to ensure awareness and education on drug safety matters for Company employees, including medical representatives.