Pharmacovigilance Quality Assurance Specialist

ABOUT CURIUM

The Group Curium is the world’s largest nuclear medicine company with over 1 b € revenues. At Curium, we have a singular focus – to develop, manufacture and supply world-class radiopharmaceutical products around the globe. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 15 million patients annually. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence, and unparalleled service.

Building on its unique strengths across radiopharmaceutical product manufacturing, logistics and commercialization, and led by an agile, LBO-driven leadership team, Curium has already achieved a critical mass and is the largest player in the nuclear medicines field. This is one that has become increasingly dynamic and innovative in recent years, in particular following Novartis’ acquisitions of Advanced Accelerator Applications and Endocyte.

Position Summary

At CURIUM Pharma, we are looking for a Pharmacovigilance (PV) Quality & Compliance Specialist to ensure the full compliance of our global and local pharmacovigilance systems with quality standards and regulatory requirements.

In this role, reporting directly to the Compliance PV Manager, you will play an active role in critical processes such as SDEA management, audit/inspection preparation, CAPA tracking, and the analysis of quality indicators (KPIs).

Key Responsibilities

1. Quality Assurance & Monitoring

• Perform reconciliations with PV partners, the quality complaints database, and digital channels.
• Prepare KPIs (Key Performance Indicators) for all pharmacovigilance activities, report trends, and propose corrective actions for performance improvements.
• Initiate and manage CAPA, Deviation, and Change Control processes in the QA database, ensuring timely follow-up and closure.
• Prepare source data to maintain the CURIUM Pharmacovigilance System Master File (PSMF) and its annexes (specifically Annex B, C, and F).

2. Contract & Partner Management (SDEA)

• Create, update, and maintain Safety Data Exchange Agreements (SDEAs) for all CURIUM partners.
• Send and assess compliance questionnaires for new and existing partners; verify the implementation of obligations such as SOP dissemination and training.
• Supervise CROs and partners to ensure compliance with regulatory deadlines for Adverse Event (AE) reporting.

3. Audits & Inspections

• Contribute to the preparation of the yearly PV audit plan.
• Coordinate and prepare the PV department for internal and external audits and inspections, ensuring readiness for Agency expectations.
• Monitor the follow-up of CAPAs resulting from audits/inspections and verify their effectiveness.

4. Training & Documentation

• Implement and control the application of PV procedures (SOPs) in the eDMS.
• Review and update PV training materials and track employee training status via the LMS (Learning Management System).
• Manage the long-term archiving of pharmacovigilance documents related to local activities.

Requirements

• Education: Bachelor’s degree in Pharmacy, Biology, Chemistry, or related Life Sciences.
• Experience: Minimum 2-4 years of experience in the Pharmaceutical industry, specifically in Pharmacovigilance or Quality Assurance (QA).
• Regulatory Knowledge: Strong knowledge of Good Pharmacovigilance Practices (GVP) and local/international regulations.
• Technical Skills: Practical experience in managing SDEAs, updating PSMF, and handling Audit/CAPA processes is highly preferred.
• Language: Fluent in English (Written and Spoken) is mandatory for global communication and documentation.
• IT Skills: Proficient in MS Office; experience with safety databases, eDMS, and LMS systems is an asset.
• Competencies: Strong analytical thinking, attention to detail, excellent planning/organizational skills, and a proactive team player.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.