As Junior Safety Scientist, you have several responsibilities.
- You contribute and interact with stakeholders (i.e. the Safety Evaluation and Risk Management (SERM) group, local operating companies (LOCs), MAPs and clinical operations) to ensure that all documentation and processes are in place to achieve successful recording and reporting of safety data during the life cycle of a clinical trial and a product (following approval).
- You liaise with other CMG divisions (Quality & Compliance and Alliance) to achieve successful recording and reporting of safety data during the life cycle of a clinical trial and a product (following approval).
- You contribute to CAPA development
- You work across a complex matrix environment to drive high-quality delivery of case management activities that comply with internal standards and external regulatory requirements
- You manage Liaison mailboxes for Spontaneous and Clinical Trial queries and responds to allocated queries in a timely manner
- In case of problem or issues, you escalate to Global CMG Liaison Manager
- You generate new ideas and proposals for global implementation; contributes to advancement of CMG methodology and processes
- You build external relationships with key stakeholders
- You have a University degree in Life Sciences or in a medical related field and you have a first experience in Safety/Pharmacovigilance (internship or working experience).
- You have a good knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP), clinical safety documentation, reporting of adverse events from clinical trials, local regulatory requirements, and pharmacovigilance methodology
- A general understanding of worldwide regulatory requirements is a strong asset
- You have a good knowledge of principles of data collection, manipulation and retrieval and experience summarizing data
- You are fluent in English
- You have strong organizational and time management skills
- You have strong communication skills