🔬 Werden Sie Teil von AiCuris: Pharmacovigilance Officer/EU-QPPV (m/w/d) in Deutschland

Join AiCuris as a Pharmacovigilance Officer, a pivotal role ensuring drug safety. You'll be an integral part of project teams, contributing your expertise to all pharmacovigilance aspects throughout drug development, from discovery to regulatory approval. A key long-term objective is to expand AiCuris' drug safety capabilities towards becoming a marketing authorization holder.

Responsibilities:

• Manage all drug safety aspects for drugs in development and future marketed products.
• Oversee the risk-benefit profile of all drugs under development.
• Serve as the primary contact for regulatory agencies regarding safety and lead PV inspections in Europe.
• Assume EU-QPPV responsibility and the Graduated Plan Officer (Stufenplanbeauftragter (m/w/d)) function as needed.
• Implement and maintain the pharmacovigilance system, establishing its system master file.
• Ensure compliance with GVP modules as defined by the European Commission.
• Continuously monitor the regulatory landscape and scientific literature related to pharmacovigilance.
• Review and amend safety information in development documents.
• Write and review adverse event narratives and periodic reports.
• Manage standard operating procedures in pharmacovigilance, ensuring regular updates and training adherence.
• Oversee service providers.

• Academic degree in life science, preferably in human medicine.
• Profound medical and pharmaceutical knowledge.
• At least 5 years of proven experience in pharmacovigilance management within the pharmaceutical industry, including regulatory drugs in development.
• Strong organizational, communication, and intercultural skills.
• Flexible and scientific working style with a commitment to continuous learning.
• Highly motivated to contribute to a growing and evolving organization.
• Proficient in standard and specific software (e.g., Microsoft Office and electronical pharmacovigilance software).
• Good English (oral and written) and German (advantageous but not a primary requirement) language skills.

• Unique corporate culture: Scientific excellence, a collaborative working environment and the passion to improve the lives of patients defines our work. With us, you can work together with innovation awarded experts with the proven ability to translate science into commercial success. You can expect diversity, inspiration as well as trustful collaboration.
• Development: We encourage people to grow and strongly support individual development and learning opportunities.
• Flexibility: Embracing flexible working accommodations we enable our people to integrate business into their personal life.
• Benefits: Employer-funded pension comes along with an attractive benefits package.

AiCuris Anti-infective Cures AG is a leading clinical-stage pharmaceutical company developing novel, therapeutic candidates for the prevention and treatment of severe and potentially life-threatening infectious diseases in immunocompromised patients. Our front-runner drug Prevymis®, a prophylactic treatment for CMV infection in transplant patients, is marketed globally since 2017 by MSD (Merck & Co.). Prevymis® is followed by an innovative pipeline of antiviral agents including our wholly owned therapeutic candidate Pritelivir, which is currently in phase III pivotal clinical development.