Local PV & Regulatory Affairs Liaison (Australia)

Ergomed; Brussel Hoofdstad; On-site; EUR 50,000 - 70,000; Full time

Job summary

Ergomed Group is seeking a Specialist, Local RA & PV Network to act as Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs, ensuring compliance with national PV and regulatory obligations. You will support MAH activities and oversee local RC/RA processes.

Qualifications include a Life Sciences or related degree and 3+ years in PV or safety, with strong English and MS Office skills. The role involves collaboration across regulatory and PV teams and audits.

Qualifications

• Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent professional experience.
• At least 3 years of pharmacovigilance or safety-related experience in pharmaceutical, CRO, or regulatory environment.
• Good understanding of ICH GVP and local pharmacovigilance requirements (training or practical exposure).
• Experience in case handling, literature screening, or local PV activities is preferred.

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 as per local requirements.
• Provision of local regulatory intelligence screening and expert advice for the responsible region(s).
• Collection and reporting of locally suspected ADRs or icsrs (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 website/s for potential Adverse Drug Reactions (ADRs) and safety information
• Maintain accurate records and documentation at local level.
• Provide support to the RA & PV Global operations team.
• Preparation and collection of documentation for submissions to the regulatory authorities.
• Review and linguistic input on local Product Information and Mock-ups.
• Ensure compliance with MAH's and PrimeVigilance's procedures.
• Support audits and Inspections.
• Handle local QA tasks such as suspected falsified products, quality alerts received from health authorities and other quality-related requirements received from the local market

Skills

English proficiency

MS Office

Education

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

Tools

Microsoft Office

Job description

Ergomed Group is seeking a Specialist, Local RA & PV Network to act as Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs, ensuring compliance with national PV and regulatory obligations. You will support MAH activities and oversee local RC/RA processes.

Qualifications include a Life Sciences or related degree and 3+ years in PV or safety, with strong English and MS Office skills. The role involves collaboration across regulatory and PV teams and audits.