The BioInvent team covers all aspects of drug development, including discovery, preclinical and translational research, manufacturing, and clinical development. Together we are creating the exciting future of BioInvent, and we welcome you to our Clinical Development Team.

Safety Scientist –

Safety and Pharmacovigilance

The global safety scientist role is responsible for providing scientific expertise to safety surveillance and risk management activities for BioInvent products in clinical development. The role actively supports the BioInvent Safety and Pharmacovigilance function and closely collaborates with the Safety Physician and Medical Directors.

This role also provides support to BioInvent Medical Directors e.g. review the safety data in the clinical database and raise queries as required, participate in investigator calls/meetings, and support preparation of safety material for scientific meetings.

Key responsibilities

• Perform signal detection activities
• Participate in periodic safety data review meetings, support the medical director in preparation of material, and coordinates the meetings
• Support/Lead DSUR and PSLL development or oversee the vendor preparing the DSURs/PSLLs and contribute to the risk evaluation and benefit-risk assessment
• Contribute to study document development e.g. study protocol and IB
• Provide support to Safety operations as required e.g. SAE management and reconciliation, vendor management and compliance monitoring
• Participate and provide support in Audits and Inspections
• Support the Medical Director in review and assessment of clinical safety data
• Support MedDRA coding review as required
• Proactively contribute to process improvement activities
• Maintain a central repository of drug safety documents, including records of signal detection and other PV activities pertinent to regulatory inspections
• Support oversight of CRO Medical Monitoring and Safety activities to ensure appropriate and timely handling of safety issues
• Close collaboration with other functional areas to achieve business goals and objectives

Requirements

To succeed in this role, you have, at least, a bachelor’s degree in life sciences/pharmacy/nursing degree. You need to have four or more years of clinical drug development experience in the biopharmaceutical industry or a related sector (e.g. academia; CRO; etc). Preferably including 2-3 years of experience in a clinical drug safety related role, ideally in early development.

Other requirements are

• Good knowledge of international pharmacovigilance requirements, specifically in Europe and US
• Good understanding of ICH-GCP
• Experience in safety signal detection activities
• Previous experience in DSUR preparation, writing and/or review

· Understanding of the MedDRA and use of safety databases for adverse event evaluation and reporting

• Experience working with vendor teams and providing oversight of outsourced safety activities
• Ability to prioritise and handle projects simultaneously
• Prior therapeutic experience in oncology would be an advantage
• Strong presentation skills, effective at summarizing and presenting the key considerations and decision points
• Proficient in written and spoken English
• Literature review experience is beneficial

Personal suitability is of great importance. You are efficient, have a strong commitment and ability to make things happen. You understand the importance of achieving results, keeping deadlines while securing high quality deliverables. You are enthusiastic, a kind person and enjoy creating results and achieving goals both individually and together with your teams.

The company is in Lund, Sweden. However, relocation is not a requirement for European residents.

BioInvent is in a unique situation with a great potential to change the future. If this is your profile and would like to contribute to change the way cancer is treated today, you are welcome to apply for the position, we want to hear from you!

Please send us your application, personal letter and CV and tell us why you are the right person for this position, at the latest the 28th of October 20204. Interviews will be held continuously which means the positions can be filled before deadline.