Associate Global Safety (33726)

Orion Group Life Sciences are looking for an Associate Global Safety for our Multinational Pharmaceutical/Biotechnology client based in Breda. Initial 6-month contract, with possibility of extension to a year. This is a part-time position, where you have to work 24 hours per week and with preference for Monday, Wednesday and Friday, but this is flexible in number of hours per day and/or days. This is a hybrid position, but you have to be at least 1 day in the office. When onsite office tasks are needed, there is a need to be flexible to come to site a bit more.

What will you do

You will log into our Safety Database to see which tasks (Action Items) are assigned to the Netherlands safety group (our team) and will work to resolve the tasks (Action Items) coming from the PSPs, clinical trials (CT) and spontaneous reports (SP).

PSPs are homecare programs where third-party nurses go to patients' home to explain the use of our clients' products and in some cases administer the product to the patient. When patients experience an adverse event during the homecare program, this will be reported to our client. To evaluate these adverse events, we need additional information from the prescribing physicians (HCPs) who enrolled their patients into the homecare program. You will look up in the system who the HCP is of the relevant patient and, depending on the task, send out the questions to the HCP by a letter. Our experience is that around 50 physical letters go to HCPs during an average week, but this can vary a lot. This colleague will primarily be responsible to send out letters to Dutch Health Care Professionals (HCP) to gain additional information on adverse events in patients who are enrolled in Dutch Patient Support Programs (PSPs).

The safety associate is also responsible for distributing additional risk minimization measures (aRMMs) and process the received follow up letters.

Responsibilities

• Performs timely & accurate local processing steps for all adverse events reported to the local affiliate, from all sources (letters, email or by phone), to enable entry into the Global Safety Database.
• Timely submission of all reportable adverse drug reaction reports & the distribution of periodic safety reports or urgent safety communications, as required by local regulations and our clients' procedures.
• Facilitates exchange of adverse event information with functional service providers, in line with specific agreements or procedures.
• Works with Safety Manager and Senior Safety Associate to maintain required standard of local operating performance and reporting compliance for AE case and periodic safety reports.
• Participates in resolution of local issues that occur, through CAPAs and related activities.
• Ensures local quality assurance measures to maintain inspection readiness of local safety function.

Requirements

• MBO+ or HBO degree.
• Strong administrative profile (experience with Office).
• Work according to standardized English procedures.
• Fluent in Dutch and English (due to correspondence and documents in English).
• Eye for detail.
• Good communication skills.
• Team-Player.
• Computer literacy with some knowledge of database use.
• Proactive in seeking assistance in unfamiliar situations.
• Customer oriented.

If you would like to have a confidential conversation regarding this opportunity please reach out to Tim Browaeys, tim.browaeys@orioneng.com or contact Tim on 0044 7593448607

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As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.