GVP Consultant

Apotech is a Life Science Management Consultancy, delivering outsourced services in Quality and Regulatory Affairs. After three successful years, we are in a growing phase with big ambitions! Fundamental to the business is to continue to create an organisation where employees are excited to come to work, are proud of what we do & who we are and push the boundaries of social responsibilities. We are now seeking a GVP Consultant to join our amazing team. 

Job Title: Freelance GVP Consultant or Auditor 

Location: Flexible/Remote or willing to travel onsite within the EU 

Position Overview: 

We are seeking a highly skilled and experienced freelance Good Pharmacovigilance Practice (GVP) Consultant to join our team. The ideal candidate will have a deep understanding of pharmacovigilance regulations, drug safety principles, and industry best practices. As a freelance consultant, you will provide expert guidance, support, and strategic advice to pharmaceutical companies, biotechnology firms, and regulatory agencies to ensure compliance with pharmacovigilance requirements and promote patient safety.

Responsibilities:

• Advise clients on pharmacovigilance regulations, guidelines, and requirements issued by regulatory authorities such as the FDA, EMA, MHRA, and other global regulatory agencies.
• Review and assess clients’ pharmacovigilance systems, processes, and procedures to ensure compliance with Good Pharmacovigilance Practice (GVP) guidelines and applicable regulatory requirements.
• Develop and implement pharmacovigilance risk management plans (RMPs), signal detection strategies, and risk minimization measures to proactively identify and mitigate safety risks associated with medicinal products.
• Assist clients in establishing and maintaining pharmacovigilance quality management systems (QMS), including the development of pharmacovigilance SOPs, training programs, and quality metrics.
• Conduct pharmacovigilance audits, inspections, and gap assessments of clients’ pharmacovigilance operations, vendors, and partners to identify areas of non-compliance and opportunities for improvement.
• Guide the collection, assessment, and reporting of adverse drug reactions (ADRs), including the preparation and submission of individual case safety reports (ICSRs) to regulatory authorities and the maintenance of pharmacovigilance databases.
• Review and evaluate post-marketing safety data, clinical trial data, literature reports, and other sources of safety information to identify potential safety signals, trends, and emerging risks.
• Support clients in preparing and submitting pharmacovigilance regulatory filings, including Periodic Safety Update Reports (PSURs), Risk Evaluation and Mitigation Strategies (REMS), and other post-marketing safety reports.

Requirements:

• Bachelor’s degree in pharmacy, life sciences, or a related field. 
• Advanced degree (e.g., master’s or Ph.D.) preferred.
• Proven track record of successfully implementing pharmacovigilance systems, processes, and procedures in compliance with regulatory requirements and industry standards.
• Certification in pharmacovigilance (e.g., RPh, PharmD, DABT) or relevant professional certifications preferred.