Local PV & Regulatory Affairs Liaison (Contract)

PrimeVigilance Ltd.; Australia; On-site; AUD 120,000 - 180,000; Full time

Job summary

PrimeVigilance Ltd. in Australia is seeking a Local Contact Person for Pharmacovigilance and Regulatory Affairs on a contractor basis.

The role ensures compliance with national PV and regulatory requirements, executes PV/RA activities locally, and supports MAH product lifecycle compliance. The successful candidate will oversee local communications with MAH and authorities, provide regulatory intelligence, manage local PV activities, and contribute to local QA and documentation for submissions,

Qualifications

• Bachelor’s Degree in Life Sciences, Chemistry, Nursing or equivalent.
• Min 3 years of pharmacovigilance or safety experience in pharma/CRO/regulatory.
• Knowledge of ICH GVP and local PV requirements (training or practical exposure).
• Experience in case handling or literature screening preferred.
• Regulatory Affairs experience preferred but not mandatory.
• Proficiency in English; additional languages advantageous.
• Strong MS Word, Excel and PowerPoint skills.

Responsibilities

• Prompt and effective communication with MAH and local regulatory authorities as required.
• Primary contact person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance.
• Provision of local regulatory intelligence screening and expert advice for the responsible region(s).
• Collection and reporting of locally suspected ADRs or ICDRS (FUs, translations).
• Local management/oversight of risk minimization measures related to urgent safety restrictions and emerging safety issues.
• Support with development and implementation of local pharmacovigilance system in compliance with Global MAH's system and local regulations.
• Perform local non-indexed literature screening and screening of regulatory authority websites for potential ADRs and safety information.
• Maintain accurate records and documentation at local level.

Skills

Pharmacovigilance

Safety reporting

English proficiency

Education

Bachelor's degree in Life Sciences or Chemistry, Nursing

Tools

MS Office

Job description

PrimeVigilance Ltd. in Australia is seeking a Local Contact Person for Pharmacovigilance and Regulatory Affairs on a contractor basis.

The role ensures compliance with national PV and regulatory requirements, executes PV/RA activities locally, and supports MAH product lifecycle compliance. The successful candidate will oversee local communications with MAH and authorities, provide regulatory intelligence, manage local PV activities, and contribute to local QA and documentation for submissions,