- Have the overview of the medicinal product safety profiles and benefit-risk evaluations during its lifecycle, including monthly overview of individual case safety report (ICSR)/serious adverse event (SAE), perform signal detection and author aggregate reports.
- Act as product specialist and have a good knowledge of Camurus products and ensure that information is captured and presented accurately in the safety database.
- Act as subject matter expert in relation to benefit-risk evaluations.
- Conduct and drive the digitalisation, automatization, and surveillance activities of safety system and database in accordance with applicable legislation.
- Ensure compliance of all activities under Camurus responsibility within surveillance for Camurus products and with partners with whom Camurus hold a Safety Data Exchange Agreement (SDEA).
- Conduct review and quality control of ICSRs/SAE.
- Ensure timely submission and exchange of ICSRs/SAEs.
- Support in the review and compilation of ICSR submission and ICSR exchange compliance.
- Develop the quality system in the area of expertise, as per GVP requirement.
- Support the QPPV to enable the QPPV to maintain oversight of the PV system, in particular for benefit-risk evaluations activities.
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Patient Safety Manager - Lund, Sverige - Bonesupport Ab
Beskrivning
Camurusis a Swedish research-based pharmaceutical company committed to developing and commercializing innovative and long-acting medicines for the treatment of severe and chronic conditions, including opioid dependence, pain, cancer and endocrine disorders. New drug products are based on our proprietaryFluidCrystal drug delivery technologies with the purpose to deliver improved quality of life, treatment outcomes and resource utilization. The company's share is listed on Nasdaq Stockholm under the ticker "CAMX". For more information, visit
AtCamurusyou will get the opportunity to work with committed colleagues in a fantastic team, where the colleagues support and care foreach other.Camurusisan innovative company that is currently expanding and establishing in new markets.
Camurus is strengthening their global Patient Safety department with a new position –Patient Safety Manager. As Patient Safety Manager you will be a part of the global Patient Safety and Medical Affairs department and work in a dedicated team of 8 colleagues. The position is based at the headquarter in Lund and you will report to the Director of Patient Safety. You will be a part of the global case processing and surveillance, with the aim to deliver efficiency, quality, and compliance with worldwide pharmacovigilance regulations. As Patient Safety Manager you will overview cases and conduct safety surveillance by monitoring the benefit-risk balance of the products on the market and in clinical studies.
Roles & Responsibilities:
Being the Patient Safety Manager, you are committed to ensure patients' safety and product quality across the Camurus products. You will first and foremost ensure a compliant Pharmacovigilance System for safety surveillance for Camurus products. You will also support the digital surveillance by using data driven methods and approaches.
Your responsibility includes, but is not limited to:
This role involves daily cooperation with several departments internally, and it is a true coordination and problem-solving type of role.
Candidate profile
We are looking for a candidate with a minimum of 5 years' experience within drug/patient safety/pharmacovigilance from the pharmaceutical/medical device industry. You probably have a background as a pharmacist, nurse or have an education within pharmacology or pharmaceutical science. You have experience from ICSR/SAE processing, risk management plan writing, signal detection, aggregate report compilation, and have worked with clinical trials. Previous experience from working with case processing in safety databases is required and if you have IT experience it is a merit. Head office/Headquarters level experience is a merit.
You have an analytical mindset, and you enjoy solving problems This position requires an ability to work with autonomy and independence, as well as cross-functional collaboration. You are able to prioritise effectively and meet multiple deadlines successfully. Enjoying a dynamic and multitasking business environment.
A good level of spoken and written English is required.
Camurus offers
This is a great opportunity to join a highly innovative and dynamic company during a very exciting phase of growth. Camurus has been very successful in bringing pharmaceutical products to the market - and the ambitions are not to be lowered. With a diversified project portfolio in different stages, the commercial potential is considerable. The position offersaninternational work environment in a research-driven company, with the possibility make a real difference for Patient Safety. You will have the opportunity to build something from scratch, and you will work together with committed and knowledgeable colleagues.
Camurushas approximately 200 employees with the head office located in Lund. The corporate culture is driven by innovation, strong collaboration internally and externally, ownership, quality, and passion about realizing ideasto achieve apatient-centric vision.
Camurus offers
For more information about this job-opening, please contact recruitment consultant Tobias Lorentzon at TOBLOR Consulting, phone: You apply for this position through TOBLOR's career site, , by uploading your CV and personal letter. For more information about Camurus, please visit: .
We are looking forward to seeing your application
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