Pharmacovigilance (QPPV)

Global Linkers Limited - Our client is a growing Pharmaceutical Manufacturing company committed to producing safe, effective, affordable, and high-quality medicines in accordance with national and international regulatory standards. They are recruiting to fill the position below:

Job Title: Pharmacovigilance (QPPV)

Location: Calabar, Cross River

Employment Type: Full-time

Industry: Pharmaceutical Manufacturing Summary Qualified Person for Pharmacovigilance (QPPV) is required to coordinate pharmacovigilance activities and ensure compliance with applicable NAFDAC drug safety requirements.

Responsibilities

Establish, implement and maintain the company's Pharmacovigilance System and associated documentation. Coordinate the collection, assessment, documentation and reporting of suspected Adverse Drug Reactions (ADRs) and other reportable safety information. Ensure timely submission of Individual Case Safety Reports (ICSRs) to NAFDAC in accordance with applicable reporting timelines. Develop and maintain pharmacovigilance SOPs, safety databases, reporting procedures and training programmes. Coordinate signal detection, safety evaluation and benefit-risk monitoring of the company's pharmaceutical products. Prepare Periodic Safety Update Reports (PSURs/PBRERs) and Risk Management Plans (RMPs), where required. Serve as the primary pharmacovigilance contact with NAFDAC and other relevant regulatory authorities. Collaborate with Quality Assurance, Regulatory Affairs, Production and Sales teams on product safety issues. Coordinate pharmacovigilance training for Medical Representatives and other relevant employees. Support pharmacovigilance audits, regulatory inspections and implementation of corrective and preventive actions.

Requirements

Bachelor of Pharmacy (B.Pharm), Doctor of Pharmacy (Pharm.D) or another relevant healthcare qualification acceptable under applicable NAFDAC requirements. Current professional registration and practising licence, where applicable. Minimum of *3–5 years' relevant experience* in pharmacovigilance, regulatory affairs, pharmaceutical manufacturing or drug safety. Sound knowledge of NAFDAC pharmacovigilance requirements, Good Pharmacovigilance Practices (GVP) and relevant ICH guidelines. Practical experience in ADR reporting, safety data management and regulatory documentation. Familiarity with MedDRA coding, signal detection and pharmacovigilance reporting systems will be an added advantage. Excellent analytical, organisational, communication and documentation skills. Ability to work independently and coordinate cross-functional pharmacovigilance activities.