Regulatory / Pharmacovigilance Executive at UnoCasa Limited

UnoCasa is a full service Human Resources Consultancy business with focus on Talent Acquisition, Learning & Development and Consultancy services. Our raison d’etre is the notion that your people are your advantage and proffer people-centric solutions to ensure your team accomplish your business goals.

We are not your run of the mill HR Company, we believe in team diversity and teamwork; we believe that the workplace should have an ambience that inspires productivity of the team; and the application of technologies to enhance efficiency. We know that every business is unique and tailor HR solutions to your organisation’s needs.

Our clients are in various sectors not limited to engineering, education, health oil & gas, government, media, finance, retail, lifestyle, consultancy firms and services

We are recruiting to fill the position below:

Job Title: Regulatory / Pharmacovigilance Executive

Location: Lagos
Employment Type: Full-time

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.

Application Closing Date
Not Specified.