UnoCasa Limited was incorporated in 2009 to provide companies with business solutions in Marketing, Business Strategy , Recruitment and general Human Resources consultancy.
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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.
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