Regulatory / Pharmacovigilance Executive at Estrada International Staffing Solutions

Job Overview

Location
Lagos, Lagos
Job Type
Full Time
Date Posted
2 years ago

Additional Details

Job ID
60559
Job Views
130

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.


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