Local PV & Regulatory Affairs Liaison (Contractor)

PrimeVigilance Ltd.; Brussel Hoofdstad; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

PrimeVigilance Ltd. is seeking a Local Contact Person for Pharmacovigilance and Regulatory Affairs (Contractor) to oversee local RA & PV activities for the Australian MAH, ensuring compliance with national PV and regulatory requirements.

You will manage local safety reporting, regulatory intelligence, and MAH communications with a focus on patient safety and lifecycle compliance. The role requires a Life Sciences degree and 3+ years PV/RA experience, strong MS Office skills, and fluency in

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.
• Prior experience in Regulatory Affairs is preferred but not mandatory.
• Proficiency in English and additional language knowledge is advantageous.
• Strong skills in Microsoft Office applications, including Word, Excel, and PowerPoint.

Responsabilités

• 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

Connaissances

PV experience

Regulatory knowledge

Case handling

MS Office

Formation

Bachelor’s in Life Sciences/ Chemistry/ Nursing or equivalent

Outils

Microsoft Word

Microsoft Excel

PowerPoint

Description du poste

PrimeVigilance Ltd. is seeking a Local Contact Person for Pharmacovigilance and Regulatory Affairs (Contractor) to oversee local RA & PV activities for the Australian MAH, ensuring compliance with national PV and regulatory requirements.

You will manage local safety reporting, regulatory intelligence, and MAH communications with a focus on patient safety and lifecycle compliance. The role requires a Life Sciences degree and 3+ years PV/RA experience, strong MS Office skills, and fluency in