Job Description
Job Description
- They are seeking an experienced Regulatory/Pharmacovigilance Executive to join our team. The successful candidate will play a pivotal role in ensuring the safety, compliance, and quality of our pharmaceutical products, in line with local and international regulations.
Responsibilities
- 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.
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.
Salary
N250,000 per month.
Application Closing Date
10th October, 2023.