Safety & PV Manager
BioInvent International AB / Biomedicinjobb / Lund
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hela Sverige Visa alla jobb hos BioInvent International AB i Lund 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 be part of it - as our
Safety & PV Manager - Clinical Development
As our Safety & PV Manager you will contribute and support aspects of clinical studies and maintain comprehensive knowledge of Drug Safety and Pharmacovigilance in drug development.
The Safety & PV Manager is responsible for providing structured and detail-oriented day to day activities pertaining to product safety and pharmacovigilance in clinical development, ensuring appropriate safety assessments and surveillance, compliant regulatory authority reporting, development and implementation of risk management strategies, and communication of safety information.
The main responsibilities are to:
• Lead the SAE/SUSARs processing, exercise judgement and apply knowledge in assessing the events and generate appropriate queries in collaboration with medical team and support regulatory reporting
• Directly oversees the CROs Drug Safety activities to ensure that they fulfill their accountabilities and responsibilities
• Support SAE Reconciliation activities for all ongoing trials
• Organize and lead ongoing safety data review such as signal detection, aggregate safety reporting, benefit-risk evaluation, risk management and mitigation plans for clinical programs
• Lead or contribute to development of DSUR, RMP, PBRER, RSI, Annual Safety Report and contribute to safety sections of relevant documents
• Up to date on literature review on Product Safety in relevant therapeutic area when pertinent to products
• Collaborate with flexibility in cross-functional teams and/or CROs
• Ensure compliance with SOPs and regulatory requirements. Formulate and implement improvements as needed.
• Contributing to Safety related meetings such as Safety Committee meeting, Cohort Review Meeting and/or Data Monitoring Committee
• Ensure compliance with ICH-GCP and support the team in maintaining a clinical Quality Management System.
Essential for the role
To succeed in this opportunity, you will have an accredited master's or higher degree in life sciences or healthcare field, such as pharmacist, nurse, or scientist with relevant pharmacovigilance experience. A qualification/experience in oncology/hematology is an advantage. You must have at least 3-4 years clinical development experience in the biotech or pharmaceutical industry.
Desirable for the role
• Working knowledge of ICH/GCP Guidelines, FDA, EMA and other regulatory requirements; MedDRA and WHO_DRUG dictionaries
• Experience in SAE case processing and working with safety databases.
• Proven knowledge of GCP, GDP and GVP
• Proficient in MS Office, and other necessary IT tools
• Excellent written and verbal communication skills; fluent in medical terminology
• Ability to multi-task and balance day-to-day drug safety activities and project work with tight timelines
• Problem-solving skills, ability to work independently and in a collaborative team setting
• Proficient in written and spoken English
• Comply with BioInvent policies, instructions and training requirements
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 new position, at the latest 4th of September. Interviews will be held continuously which means the positions can be filled before deadline.
Så ansöker du Sista dag att ansöka är 2023-09-04
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Bioinvent International AB (org.nr 556537-7263)
Sölvegatan 41 (
visa karta)
223 70 LUND
Arbetsplats BioInvent International AB
Jobbnummer 8021632
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