Local PV & Regulatory Affairs Liaison

PrimeVigilance Ltd.; Australia; On-site; AUD 90,000 - 130,000; Full time

Job summary

PrimeVigilance Ltd. in Australia is seeking a Local RA & PV Specialist (Permanent or Contractor) to act as Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs.

You will ensure compliance with national requirements and support MAH activities locally. In this role you will handle PV/RA tasks, liaise with authorities, provide regulatory intelligence, manage local safety reporting, and contribute to the development of the local PV system while upholding PrimeVigilance

Qualifications

• 3+ years in pharmacovigilance or safety in pharma/CRO/regulatory environments
• Strong understanding of ICH GVP and local PV requirements
• Experience with case handling or literature screening is preferred

Responsibilities

• Act as Local Country Person Responsible for PV/RA and ensure compliance in Australia
• Coordinate local regulatory affairs activities and liaise with MAH
• Provide local regulatory intelligence screening and expert advice
• Collect and report locally suspected ADRs and ICIs
• Support PV system development and regulatory submissions

Skills

English proficiency

Education

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

Tools

Microsoft Office

Job description

PrimeVigilance Ltd. in Australia is seeking a Local RA & PV Specialist (Permanent or Contractor) to act as Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs.

You will ensure compliance with national requirements and support MAH activities locally. In this role you will handle PV/RA tasks, liaise with authorities, provide regulatory intelligence, manage local safety reporting, and contribute to the development of the local PV system while upholding PrimeVigilance