Local Contact Person – Pharmacovigilance, Regulatory Affairs

This is a fully remote position, open to applicants in Slovenia.

📋 Description

• Serve as the Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA).

• Act as the main local representative for Regulatory Affairs and Pharmacovigilance in Australia.

• Ensure adherence to national pharmacovigilance and regulatory standards.

• Implement local pharmacovigilance and regulatory affairs initiatives.

• Assist the Marketing Authorisation Holder in ensuring product compliance throughout its lifecycle.

• Communicate swiftly and effectively with the Marketing Authorisation Holder and local regulatory agencies.

• Function as the primary liaison for local regulatory authorities regarding Regulatory Affairs and Pharmacovigilance issues.

• Analyze local regulatory intelligence and offer expert guidance for the responsible regions.

• Gather and report locally suspected adverse drug reactions and individual case safety reports, including follow-ups and translations.

• Oversee or manage risk-minimization strategies concerning urgent safety restrictions and emerging safety concerns.

• Aid in the development and execution of the local pharmacovigilance system, ensuring compliance with global systems and local regulations.

• Conduct local non-indexed literature reviews and monitor regulatory-authority websites for potential adverse drug reactions and safety information.

• Maintain precise local records and documentation.

• Provide support to the Regulatory Affairs and Pharmacovigilance Global Operations team.

• Prepare and gather documentation for submissions to regulatory authorities.

• Review and offer linguistic input on local Product Information and mock-ups.

• Ensure compliance with the procedures of the Marketing Authorisation Holder and PrimeVigilance.

• Assist with audits and inspections.

• Manage local quality assurance responsibilities, including issues related to suspected falsified products, health authority quality alerts, and other local market quality requirements.

⛳️ Requirements

• Bachelor’s Degree in Life Sciences, Chemistry, Nursing, or equivalent professional experience.

• Minimum of 3 years of experience in pharmacovigilance or safety-related roles within pharmaceutical, CRO, or regulatory environments.

• Solid understanding of ICH GVP and local pharmacovigilance requirements gained through training or hands-on experience.

• Preferred experience in case handling, literature reviews, or local PV activities.

• Previous experience in Regulatory Affairs is advantageous but not essential.

• Proficient in English.

• Knowledge of additional languages is a plus.

• Strong competency in Microsoft Office applications, including Word, Excel, and PowerPoint.

• Capability to serve as the Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs.

• Familiarity with national pharmacovigilance and regulatory requirements in Australia.

• Ability to assist with audits and inspections.

• Competence in managing local QA tasks, including issues related to suspected falsified products and health authority quality alerts.

🏝️ Benefits

• Option for remote work.

• Permanent or contractor employment arrangement.

• Collaborative and supportive team atmosphere.

• Flexible work culture that promotes growth and belonging.

• Opportunity to collaborate with global teams across Europe, North America, South America, Asia, and Australia.

• Opportunities for professional growth.

• Purpose-driven work aimed at protecting patients.

• Exposure to experts in clinical research, pharmacovigilance, and quality consulting.