Medical Doctor

9/2016 – 12/2017

- Write and coordinate (periodic) reports such as PBRER/PSUR, DSUR, RMP, ACO and other related safety documents.
- Developing and maintaining templates for safety documents.
- Support the Global Safety Lead in developing and maintaining the global safety profile incl. label management activities and strategic risk management.
- Preparation of responses to safety-related inquires from regulatory agencies and ethics committee in collaboration with the Global Safety Lead.
- Safety review of aggregate safety data including signal detection/validation/evaluation during all phases of the life-cycle in collaboration with the Global Safety Lead.
- Author, contribute, review and maintain safety sections of clinical documents including investigator's brochure, clinical trial protocols, clinical study reports and other relevant project/study documents in collaboration with the Global Safety Lead.
- Prepare and share safety information with licensing partners, review safety documents prepared by licensing partners, communicate safety matters with partners per the safety agreement.
- Training of DS HQ personal, LRP-PVs, Regional Drug Safety Center LatAm and other non-safety departments on processes.
- Scientific (medical/pharmaceutical) evaluation and review of Individual Case Safety Reports (ICSRs) of any Grünenthal (investigational) medicinal product(s), determination of follow up content and activities.

Humanmedizin, Pharmakologie, GXP, Medizin

9/2009 – 7/2014

- Explored the novel functions of a prefoldin-like complex member protein in miRNA biogenesis.
- Developed potential pro-apoptotic peptide drugs for ovarian cancer.
- Generated a genetically knockout mouse model; developed and executed breeding plans to achieve homozygous deletion of the target gene; mouse colony maintenance.
- Lectured in Laboratory courses in Basic Biology and Cell Biology/Molecular Medicine.

Medizinforschung, Forschung & Entwicklung, Humanmedizin, Onkologie, Biologie