Pharmacovigilance Officer/ EU-QPPV* (Reporting to the Chief Medical Officer

at  AiCuris Antiinfective Cures AG

YOUR MISSION

At AiCuris, the role of the Pharmacovigilance Officer is of the highest importance. Bringing broad knowledge to the drug safety function, you are embedded into AiCuris project teams and support drug development related to all aspects of pharmacovigilance during discovery, drug development, regulatory review and approval. One of the long-term goals of this role is to extend the AiCuris drug safety function towards a marketing authorization holder.

Responsibilities

• Responsible for all drug safety aspects within development and future marketed new drugs
• Overseeing the risk-benefit profile of all drugs under development
• Being the contact for regulatory agencies related to safety as well as the primary contact for PV inspections in Europe
• Taking over EU-QPPV responsibility as well as the Graduated Plan Officer (Stufenplanbeauftragter (m/w/d)) function at AiCuris as needed in the future
• Implementing and maintaining the pharmacovigilance system and establishing its system master file
• Ensuring adherence to the GVP modules as defined by the European Commission
• Continuous observation of the regulatory landscape and scientific literature regarding pharmacovigilance
• Reviewing and amending safety information within development documents
• Responsible for writing and reviewing adverse event narratives and periodic reports
• Responsible for standard operating procedures in pharmacovigilance, regular updates and training adherence
• Overseeing service providers

ABOUT US

AiCuris is meeting the needs of the growing population of immunocompromised people who require precise therapies to effectively treat infection. Our flagship product, PREVYMIS, marketed by our partner MSD, treats CMV in a defined group of transplant recipients. Our pivotal phase 3 candidate Pritelivir aims to address recurrent and resistant HSV infections in a broad population of patients with weakened immune systems. For immunocompromised people, an otherwise manageable infection can mean life or death. AiCuris, with its expertise and growing pipeline, is committed to providing therapeutic solutions for them now and in the future.

Passionate about our mission to develop anti-infective therapeutics for patients in need, a team of internationally recognized experts is driving our research and development to improve the lives of patients. We believe in a culture of trust and transparency, where feedback is considered an opportunity to contribute to each other’s personal and professional growth. We hire people who are collaborative, adaptable, communicate well, and love to learn.

• AiCuris is an employer that supports equal opportunities, diversity and inclusion. We welcome applications from people regardless of their national origin, skin color, religion, gender, age, marital status, disability, sexual orientation, gender identity or other legally protected characteristics.

• Responsible for all drug safety aspects within development and future marketed new drugs
• Overseeing the risk-benefit profile of all drugs under development
• Being the contact for regulatory agencies related to safety as well as the primary contact for PV inspections in Europe
• Taking over EU-QPPV responsibility as well as the Graduated Plan Officer (Stufenplanbeauftragter (m/w/d)) function at AiCuris as needed in the future
• Implementing and maintaining the pharmacovigilance system and establishing its system master file
• Ensuring adherence to the GVP modules as defined by the European Commission
• Continuous observation of the regulatory landscape and scientific literature regarding pharmacovigilance
• Reviewing and amending safety information within development documents
• Responsible for writing and reviewing adverse event narratives and periodic reports
• Responsible for standard operating procedures in pharmacovigilance, regular updates and training adherence
• Overseeing service provider