Regulatory / Pharmacovigilance Executive at UNOCASA Limited

Summary

• To ensure that the company is in full compliance to Pharmacovigilance requirement, maintain proper records and report ADRs promptly.

Duties and Responsibilities

• Acting as single contact point for NAFDAC on a 24-hour basis
• Establishing and maintaining/managing the Company’s pharmacovigilance (PV) system
• Ensuring the PV system is appropriately described in the PV System Master File (PSMF), overseeing its content and maintenance, and ensuring the availability of the PSMF to Competent Authorities (CA)
• Having an overview of the safety profiles and any emerging safety concerns in relation to the medicinal products for which Company has received Marketing Authorization
• Preparation of Periodic Safety Update Report for products and submission of same to relevant Regulatory Authorities
• Submission of Adverse Drug Reactions to NAFDAC
• Handling of suspected faking of Company’s product
• Coordinating destruction of expired and rejected products and items.
• Ensuring that Safety reporting processes are in place.
• Preparing and managing safety reports
• Collaborates with relevant functions internally to ensure an adequate level of awareness and education of Company employees, including medical representatives, as regards drug safety matters, safety data collection and reporting.

Requirements

• Bachelor's Degree in Pharmacy/Relevant Sciences
• Minimum 3 years Regulatory Experience in the industry.
• Good working knowledge of Regulations and current industry practices.