Local Responsible Person for Pharmacovigilance - Australia & New-Zealand

Join Excelya, where Audacity, Care, and Energy define who we are and how we work.
We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in PV&Safety Team[GS1] . As the Local Responsible Person for Pharmacovigilance (LRPV) in APAC region, you will play a pivotal role in ensuring compliance with local regulations, maintaining robust safety processes, and collaborating with both internal and external stakeholders to safeguard patient well-being.

Main Responsibilities:

As Local Responsible Person for Pharmacovigilance, you will:

Act as Local PV Contact

• Serve as the key contact person for local competent authorities on pharmacovigilance matters.
• Ensure full compliance with territory-specific regulatory requirements.
• Maintain oversight of product safety profiles and any emerging safety concerns.

ICSR Management

• Manage the receipt, follow-up, documentation, and reporting of safety cases, complaints, and queries in line with client procedures and regulatory timelines.
• Conduct reconciliations with internal teams and third parties.
• Escalate local safety signals and collaborate with Regulatory Affairs to ensure timely submissions to authorities.

Management of 3rd Parties

• Organizes and conducts trainings to local partners on PV requirements as per agreement and procedural requirements
• Support and maintain Safety Data Exchange Agreements (SDEAs) and other PV-related contracts.
• Monitor compliance and perform reconciliations in line with agreements.

Regulatory Intelligence & Compliance

• Monitor changes in local pharmacovigilance legislation and provide timely updates to stakeholders.
• Contribute local input to the Pharmacovigilance System Master File (PSMF).
• Ensure audit readiness and act as the primary contact for audits and inspections.
• Maintain compliance with client SOPs, policies, and documentation practices.

Operational Excellence

• Participate in trainings, audits, meetings, and inspections.
• Ensure accurate filing, storage, and tracking of vigilance records.
• Provide activity reports and quality control of local PV documentation.
• Act as deputy/back-up LRPV when required.

Requirements:
About You:

At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.

• Education: University Degree in Life Sciences (Pharmacy or related field).
• Experience: At least 2 years in pharmacovigilance, ideally with experience in global or regional safety roles. Previous experience as a Local Responsible Person (LRPV/QPPV) in APAC would be a strong asset.
• Skills: Excellent organizational and analytical abilities, proven independence and teamwork in a demanding multinational environment, strong communication and multitasking skills. Proficient in MS Office; familiarity with safety databases; knowledge of local APAC PV regulations. Self-motivated, detail-oriented, solution-driven, and a true team player.
• Languages: Fluent in English (written and spoken)

Benefits:
Why Join Us?

At Excelya, we combine a passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider model (full-service, FSP, and consulting) offers you diverse career opportunities across multiple projects.

Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey. Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.