Patient Safety Associate

3 weeks ago

Sverige, Sweden IOPSYS Software Solutions AB Full time

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 camurus.com.

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 Associate. As Patient Safety Associate you will be a part of the global Patient Safety and Medical Affairs department at the headquarter in Lund, and you will report to the Director of Patient Safety. The position is based in Lund, and you will work in a dedicated team of 8 colleagues. As Patient Safety Associate you will belong to the global case processing team, with the responsibilities of monitoring mailboxes and co-ordination of case processing activities, with the aim to ensure that safety data is managed with high quality, efficiently and in compliance with worldwide pharmacovigilance regulations.

Role and responsibilities

Being the Patient Safety Associate, 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 Camurus products.

Your responsibility includes, but is not limited to:

Management of individual case safety reports (ICSRs) and serious adverse events (SAEs) e.g. monitoring of safety mailboxes, perform ICSR download from health authorities including initial assessment, triage and logging of ICSRs and distribution of follow-up questions.

Processing of ICSRs in the Safety database

Support and perform reconciliations

Support and perform entries in XEVMPD

Support in co-ordination of activities in relation to safety in clinical trials

Support in SOP writing by preparing and reviewing Safety/PV SOPs and other related procedural documents

This role involves daily cooperation with several departments internally, and it is a true coordination and spider-in-the-web type of role.

Candidate profile
We are looking for a candidate with a minimum of 2 years’ experience within drug/patient safety/pharmacovigilance or medical information, from the pharmaceutical/medical device industry. You probably have a background as a pharmacist, nurse or an education within pharmacology or pharmaceutical science. You have experience from managing ICSRs and SAEs, you are used to work with safety databases (e.g. ARISg/LSSMV or Argus).

You have an analytical, but open mindset, you are comfortable in raising objections and enjoy solving problems and mediating issues that may arise and the ability to propose new and more efficient ways of work. To be successful in this job, you need a structural sense and attention to details. Furthermore, you enjoy working in a dynamic and changing environment. 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 make a career in a growing company, 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.

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