We are seeking a seasoned professional to lead our global pharmacovigilance compliance efforts.
This role is pivotal in ensuring the highest standards of patient safety and regulatory compliance across all markets.
Job Description
* Oversee the development and maintenance of our Quality Management System, ensuring seamless integration with global PV agreements.
* Lead audit and inspection activities, including stakeholder training and inspection readiness.
* Coordinate with medical experts for emergency assessments, case evaluations, and benefit-risk assessments.
* Evaluate risk-benefit profiles of medicinal products authorized in the EU/UK.
Key Responsibilities
* Act as primary point of contact for Competent Authorities regarding safety requests/questions for medicinal products licensed in the EU/UK.
* Monitor emerging safety concerns and oversee safety profiles.
* Review and support PV content in drug labeling.
* Manage CAPA handling of audit observations.
Required Skills and Qualifications
* Demonstrated expertise in pharmacovigilance and quality management systems.
* Excellent leadership and communication skills.
* Able to work effectively in a fast-paced environment.
Benefits
The successful candidate will enjoy a dynamic and supportive work environment, opportunities for growth and development, and the satisfaction of contributing to improved patient outcomes worldwide.
Others
This role offers the chance to make a meaningful impact on public health and to be part of a dedicated team of professionals committed to excellence in pharmacovigilance and quality management.