Australia Local PV & Regulatory Affairs Specialist

PrimeVigilance Ltd.; Brussel; On-site; EUR 65,000 - 94,000; Full time

Job summary

PrimeVigilance Ltd. in Belgium is seeking a Specialist, Local RA & PV Network to ensure local pharmacovigilance and regulatory compliance for the Australian MAH. You will execute PV and RA tasks, liaise with MAH and authorities, and support local PV system development across lifecycle.

Ideal candidates have 3+ years in PV, strong ICH GVP knowledge, and good English with additional language skills. This role emphasizes accurate reporting, regulatory intelligence, and cross-functional

Qualifications

• Bachelor's degree in life sciences, chemistry, nursing or equivalent.
• At least 3 years of pharmacovigilance or safety-related experience.
• Good understanding of ICH GVP and local PV requirements.
• Experience in case handling, literature screening, or local PV activities preferred.
• Regulatory Affairs experience is an advantage.
• Proficiency in English; additional language knowledge is beneficial.

Responsibilities

• Act as Local Country Person Responsible for PV and Regulatory Affairs locally.
• Communicate with MAH and local regulatory authorities efficiently.
• Provide local regulatory intelligence and expert advice for the region.
• Collect and report locally suspected ADRs and related data.
• Oversee risk minimization measures for urgent safety issues.
• Support local PV system development compliant with global MAH and local regs.
• Perform local literature screening and regulatory website checks.
• Maintain records and documentation at local level.
• Support global RA & PV operations and submissions.
• Review local product information and mock-ups for linguistic accuracy.
• Ensure compliance with MAH's and PrimeVigilance's procedures.

Skills

English proficiency

Regulatory Affairs knowledge

PV case handling

MS Office

Education

Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent

Tools

MS Office Suite

Job description

PrimeVigilance Ltd. in Belgium is seeking a Specialist, Local RA & PV Network to ensure local pharmacovigilance and regulatory compliance for the Australian MAH. You will execute PV and RA tasks, liaise with MAH and authorities, and support local PV system development across lifecycle.

Ideal candidates have 3+ years in PV, strong ICH GVP knowledge, and good English with additional language skills. This role emphasizes accurate reporting, regulatory intelligence, and cross-functional