Pharmacovigilance Officer/ EU-QPPV* (Reporting to the Chief Medical Officer) in Deutschland bei AiCuris GmbH & Co KG

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

• Academic degree in life science, preferably in human medicine
• Profound medical and pharmaceutical knowledge
• At least 5 years proven work experience in managing pharmacovigilance in the pharmaceutical industry including regulatory drugs in development
• Good organizational, communication and intercultural skills
• Flexible, scientific working style and willingness for continuous education
• Highly motivated to contribute and work in a growing and changing organization
• Good knowledge of 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.