Pharmacovigilance Officer / EU-QPPV (m/w/d)

Responsible for all drug safety aspects within development and future marketed new drugs; Overseeing the risk-benefit profile of all drugs under development;...

The Powerhouse for Anti-infectives – Committed to making the difference

Ready to fight against infectious diseases? Join our team!

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 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

Skills and qualification

• Academic degree in life science, preferably in human medicine
• At least 5 years proven work experience in managing pharmacovigilance in the pharmaceutical industry including regulatory drugs in development
• Profound medical and pharmaceutical knowledge
• 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

What we can offer

• Cooperation in multinational and interdisciplinary teams
• An exciting field of activity in a promising research and development company
• Flexible working hours and self-determined time management
• Flexible combination of on-site work and mobile working
• Regular and targeted further training and individual development opportunities
• Attractive remuneration and company pension scheme
• A wide range of offers in terms of health and reconciling work and family life

How to apply

Interested to join our team? Then apply online (click here). If you have any questions, please do not hesitate to contact us at +49 (0)202 317 63 - 0.