Beschreibung
PV Safety Physician with knowledge in clinical trials wanted for our Lausanne based client in the pharmaceutical sector.Your experience/skills:
- Several years of working experience as a Medical Doctor or Physician with solid knowledge of international clinical development as well as post-marketing regulations
- Familiarity with relevant regulations and concepts in data management, systems epidemiology and statistics
- Competent in handling risks and propose mitigation actions in complex and critical situations
- Higher degree in clinical pharmacology, pharmacovigilance or drug safety is additional
- Languages: fluent English both written and spoken
Your tasks:
- Reporting to the Head PV Risk Management, ensuring the benefit risk assessment is current for a specific set or product along with maintaining mitigation plans, safety analyses in aggregate reports as well as medical review of ICSR
- Providing input to Risk Management Plans (RMP), Common Technical Document (CTD) or equivalent document for Dossier Registration and label as well as to Development Safety Update Reports (DSURs) and Aggregate Reports (PSUR, PBRER)
- Providing measures targeting at minimising risks during clinical development, releasing and updating the Development Risk Management Plans (DRMPs) as well as organizing meetings for products with the Product Safety Team (PST) and Portfolio Safety Committee (PSC)
- Managing the scientific review of safety related information in CCDS and CSI, maintaining product labelling and investigator brochures, contributing answers to safety related questions from Regulatory agencies or Health Authorities and involving in Investigators/KOLs meetings as well as in due diligences
- Ensuring the safety of data review during clinical trials through Safety Plans and Safety Review Meetings along with collaborating with Strategy and Innovation Group, Clinical Development group and other stakeholders to ensure effectivity
Start:
Duration: 04MM+
Location: Lausanne, Switzerland
Ref.Nr.: BH14301
Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.
Due to work permit restrictions we can unfortunately only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
Going the extra mile…
New to Switzerland? In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more