Regional Pharmacovigilance Manager

This is a fully remote position, open to applicants in Belgium, +1 more country.

📋 Description

• Assist in the oversight, harmonization, and upkeep of regional pharmacovigilance activities, processes, and deliverables.

• Contribute to the pharmacovigilance systems applicable to assigned countries or regions, ensuring alignment with global GPS processes and standards.

• Monitor and disseminate relevant pharmacovigilance laws, regulatory expectations, and safety requirements.

• Advocate for awareness of pharmacovigilance responsibilities and aid in compliance with local, regional, and global mandates.

• Oversee and maintain company and user profiles within regulatory authority databases and portals.

• Collaborate with teams from Regulatory, Medical, Quality, Legal, Commercial, and other departments.

• Build relationships with cross-functional teams engaged in adverse event reporting and safety data collection.

• Support the oversight of individual case safety report processes and ensure timely entry into the Global Safety Database.

• Manage the oversight and operational administration of pharmacovigilance outsourcing vendors.

• Engage in GPS audit and inspection preparedness, offering support and management during inspections.

• Stay informed about the company's product portfolio, disease areas, and both marketed and developmental products.

• Contribute to initiatives aimed at continuous improvement and innovation for regional pharmacovigilance efficiency and process maturity.

• Execute other relevant and requested tasks.

⛳️ Requirements

• Bachelor’s or Master’s degree in pharmacy, nursing, healthcare, life sciences, or another pertinent scientific field.

• Approximately 5 to 7 years of experience within the pharmaceutical or biotech industry, regulatory authorities, or a related environment.

• Strong background in pharmacovigilance or drug safety.

• Familiarity with pharmacovigilance regulatory requirements, GVP guidance documents, and applicable GxP quality and compliance standards.

• Experience in preparing, reviewing, or maintaining pharmacovigilance documents, procedures, work instructions, or related controlled documents.

• Extensive experience with individual case safety report processes and case management within a Global Safety Database.

• Experience overseeing or managing pharmacovigilance outsourcing vendors, including operational performance, quality assurance, and issue resolution.

• Preferred experience in audit and inspection readiness, inspection support, or participation in pharmacovigilance inspections.

• Knowledge of regional pharmacovigilance operations, safety data collection, and cross-functional PV processes is preferred.

• Strong planning and organizational abilities.

• Excellent verbal and written communication skills, including the ability to convey complex issues to diverse audiences.

• Ability to collaborate effectively across multidisciplinary and global teams.

• Understanding of safety business processes, adverse event collection, and pharmacovigilance systems.

• Strong problem-solving capabilities.

• Relevant computer skills, including proficiency in the Microsoft Office Suite.

• Fluency in written and spoken English; knowledge of additional languages is a plus.

• Candidates must be located in Belgium or Switzerland.

🏝️ Benefits

• Eligibility for short-term and long-term incentives programs.

• Locally applicable annual base salary hiring range discussed during the recruitment process.

• An inclusive environment that offers equal employment opportunities without discrimination.

• Opportunities for professional growth.