Australia Local RA & PV Specialist

Ergomed; Belgique; Presencial; EUR 60 000 - 95 000; Tempo integral

Resumo da oferta

Ergomed is seeking a Specialist, Local RA & PV Network to act as Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs, ensuring compliance with national requirements in Australia.

The role focuses on communication with MAH and local authorities, provision of local regulatory intelligence, collection of locally suspected ADRs, oversight of risk minimization, and support to the global RA & PV operations. English proficiency and life sciences background required.

Qualificações

• 3+ years of pharmacovigilance or safety-related experience
• Knowledge of local pharmacovigilance requirements and ICH GVP
• Strong communication with regulatory authorities
• Experience with case handling and literature screening is preferred

Responsabilidades

• Serve as Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs
• Communicate with MAH and local regulatory authorities
• Provide local regulatory intelligence screening and expert advice
• Collect and report locally suspected ADRs or ICSSR
• Oversee local risk minimization measures and safety issues
• Support development and implementation of local PV systems
• Prepare documentation for submissions to authorities
• Review local Product Information and mock-ups for linguistic accuracy
• Support audits and inspections
• Handle QA tasks related to quality alerts and regulatory requirements

Conhecimentos

Pharmacovigilance experience

Regulatory affairs knowledge

MS Office proficiency

English proficiency

Formação académica

Bachelor’s degree in Life Sciences or Chemistry/Nursing

Ferramentas

MS Office

Descrição da oferta de emprego

Ergomed is seeking a Specialist, Local RA & PV Network to act as Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs, ensuring compliance with national requirements in Australia.

The role focuses on communication with MAH and local authorities, provision of local regulatory intelligence, collection of locally suspected ADRs, oversight of risk minimization, and support to the global RA & PV operations. English proficiency and life sciences background required.