Pharmacovigilance (PV) Consultant

Imagine a world where life-saving medicines and vaccines reach those who need them most, faster and more safely. At EXTEDO , this is not just a vision - it’s our daily mission.

We are driven by the profound responsibility to ensure that every treatment, every cure, and every vaccine reaches patients without unnecessary delays. Our work empowers health authorities and pharmaceutical companies around the globe to navigate the complex regulatory landscape with confidence, knowing they have a trusted partner in the life science industry for managing and streamlining regulated information at every step of the pharmaceutical product lifecycle. With over 25 years of innovation, 100+ employees, and 20+ nationalities, EXTEDO stands as a leader in Regulatory Information Management (RIM).

We are looking for someone, who supports customers in the implementation, validation, and operation of pharmacovigilance and drug safety processes and solutions. The role combines regulatory expertise, business consulting, and solution knowledge to help customers achieve compliance, operational efficiency, and effective use of EXTEDO solutions and services.

Your tasks

Analyze customer pharmacovigilance processes, requirements, and challenges, and provide recommendations aligned with industry best practices and regulatory requirements

Support the implementation, configuration, validation, and adoption of drug safety solutions

Conduct customer workshops, requirements-gathering sessions, training activities, and business process assessments

Advise customers on pharmacovigilance regulations, compliance topics, process harmonization, and operational improvements

Contribute to presales activities, customer demonstrations, proposals, Statements of Work, and solution presentations related to pharmacovigilance projects

Cross-operate between Product Management, Development, Professional Services, and Customer Support to address customer requirements, enhancement requests, and solution improvements

Provide second- and third-level functional support for customer issues and service requests including the investigation, analysis, documentation, and resolution of customer support tickets related to pharmacovigilance processes and solutions

Your profile

Degree in Life Sciences, Pharmacy, Medicine, Pharmacovigilance, Regulatory Affairs, or a related discipline

Experience in pharmacovigilance, drug safety, regulatory affairs, safety operations, or related consulting activities

Knowledge of global pharmacovigilance regulations and guidelines, including EMA, FDA, ICH, and GVP requirements

Strong understanding of pharmacovigilance business processes such as case management, safety reporting, and compliance activities

Excellent analytical, communication, presentation, and customer-facing consulting skills

Ability to work effectively with customers, cross-functional teams, and internal stakeholders in an international environment