Pharmacovigilance (QPPV) at a Pharmaceutical Manufacturer via Global Linkers – Calabar

A pharmaceutical manufacturing company in Calabar, Cross River State, is recruiting a Qualified Person for Pharmacovigilance through Global Linkers Limited to oversee drug safety reporting and NAFDAC compliance.

• Industry: Pharmaceutical Manufacturing

Role overview

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.