Miltenyi Biomedicine is a newly established international biopharmaceutical company that develops innovative cell and gene therapies. We are focused on bringing cancer treatments and regenerative therapies to patients. Our initial focus is on difficult to treat hematological cancers using CAR-T technology whilst exploring treatments for solid tumors. We are currently in discussion with the FDA, EMA and Japanese health authorities regarding initiating pivotal Phase II trials. We strongly believe that despite promising developments, there is significant room to improve on current cancer therapies.
Responsibilities:In this new position, the SMSO will be part of the Pharmacovigilance and Safety team and will be responsible for overseeing safety vendors, clinical trial resource planning, reconciliation activities, tracking key performance indicators (KPIs) and report writing, as well as assisting with vendor selection, responding to or coordinating PV-related vendor requests, and writing PV-related SOPs.
- You will be responsible for implementing the quality strategy at the pharmacovigilance level, maintaining and setting quality standards for local pharmacovigilance activities
- You will be co-responsible for audits and inspections as well as ensuring the collection and monitoring of national pharmacovigilance regulations as well as the execution of other PV activities according to regulatory requirements and applicable SOPs
- You will be responsible for assisting in the preparation of periodic safety update reports (PSURs), development safety update reports (DSURs), risk management plans (RMPs) and signal detection reports
- You will consult with the Clinical Operations department regarding planned clinical trials and with participating CROs.
- You are the first point of contact for communication with health authorities
- 3-5 years of experience in medical safety, drug safety, pharmacovigilance, and/or medical affairs in the consumer, pharmaceutical, and/or medical device sectors
- Ideally experience in the area of drug safety and medical device vigilance
- As well as experience with safety inspections and knowledge of global safety regulations preferred
- Experience in planning/procedures/conducting clinical trials and overseeing them from a safety perspective
- Knowledge of GCP, GVP and related global regulations and required procedures.
- Fluent in German and English
- A modern workplace and exciting opportunities in the development of technologies with a secure future
- Cross-border intercultural cooperation and short communication channels
- A collegial corporate culture and flexible working hours enable time management on your own terms
- Personalized employee development program: specialist and personal training courses provided by our own Miltenyi University
- Diverse corporate benefits with regard to employee health, sport, and staff events
