Drug Safety Engineer

Drug Safety Engineer

Mission Description:

(LSO) Benelux:

Individual who is accountable for ensuring that pharmacovigilance systems are in place within the local organization in order to safeguard public health, and maintain compliance with applicable regulatory requirements.

Mission responsibilities for LSOs:

Implement and maintain a pharmacovigilance system for the company products authorized in their Territory and ensure compliance with applicable regulatory requirements
Maintain thorough knowledge of the national current pharmacovigilance regulatory requirements;
Ensure communication of national pharmacovigilance requirements to global Patient Safety;
Ensure that all information relevant to the benefit/risk balance of the company products is reported to Patient Safety (including the EEA QPPV for products authorized in the EEA) for further review and to the competent authorities according to the local pharmacovigilance legislation;
Work in close collaboration with global Patient Safety teams in order to ensure that local obligations are managed and compliance to local authorities
Establish and maintain the quality management system related to the pharmacovigilance system at the affiliate level;
Maintain local pharmacovigilance SOPs/AI to describe local processes and requirements and perform regular gap analysis as needed in order to ensure alignment with global SOPs;
Maintain a functional connection with the EU QPPV
Interface with key affiliate stakeholders and departments in the local office to ensure that pharmacovigilance requirements are implemented;
Establish and maintain local Safety Data Exchange Agreements (SDEA)
Ensure oversight of global SDEA which apply in the territories under LSO responsibility;
Ensure that the required local information for the Pharmacovigilance System Master File is made available to the EEA QPPV office
Participate and lead pharmacovigilance audits and inspections, ensuring timely identification and implementation of respective CAPAs;
Ensure inspection and audit readiness of the relevant local departments in full collaboration with Patient Safety and Quality Assurance.
Ensure that all local newly hired Safety staff (permanent and contractor) have the appropriate qualification and training;
Ensure that a pharmacovigilance training (obligation to immediately report any relevant safety information) is provided to any local company employee/contractor/agent of territories under LSO responsibility, including sales representatives;
Manage and develop local safety staff

Education

Bachelor's Degree, HCP based education (such as physician, pharmacist, nurse) or any relevant graduation/experience in medical-scientific area,
(such as PhD/master in biological sciences or related degree)

Experience

2-5 years in Pharmacovigilance, Scientific background in CNS and/or immunology helpful.