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Pharmacovigilance Associate (20 – 40 hours)
To support the expansion of AM-Pharma’s business, we are currently looking for a Pharmacovigilance Associate
About the role
The Pharmacovigilance Associate:
• Provides oversight to rapidly and timely processing of new and follow-up reports of adverse events and side effects (Adverse Events, or AE’s), as well as Serious Adverse Events (SAE’s) and Suspected Unexpected Serious Adverse Reactions (SUSAR’s) which are unexpected SAE’s with (possible) causality to the (study) drug, out of clinical drug research.
• Reviews the content of SAE reports for completeness, consistency, and medical plausibility.
• Focuses specifically and critically on SA events where a causal relationship is suspected or reported.
• Liaises with the external project Drug Safety Physician(s) and internal medically qualified staff to assure timely detection and proper interpretation of potential safety signals.
• Provides oversight to the processing all the AE’s, SAE’s and SUSAR’s in the Global Safety Database according to the applicable Company Policies and Standard Operating Procedures (SOP’s), and as required by the competent Authority for reporting adverse events.
• Provides oversight to timely reporting of the reportable serious adverse events to the relevant competent authorities and, in the event that the adverse events and site effects arise from clinical trials to ethics committees and / or Data Monitoring Committee (DMC) and / or Trial Steering Committees (TSC).
• Contributes to keep processes, procedures and systems up to date for recording and processing of serious adverse events.
• Assists with the preparation of audits/inspections and participate in the audit/inspection when appropriate.
• Ensures that all required documents related to reporting adverse events and aggregated reports (SLL, PSUR / PBEBR, Drug SUR, Risk Management planning & reporting, SMP (Safety Management Plans) are managed within AM-Pharma.
• Trains colleagues in the marketing and sales departments, as well as medical and clinical departments on compliance with their reporting responsibilities for Drug Safety
• Starts preparing the organization, systems and infrastructure for the drug safety related requirements associated with the commercialization of the lead product.
As soon as possible
What we expect We expect our Pharmacovigilance Associate to have:
• Biomedical Degree (Pharmacy, Medicine, Biology, Chemical Engineering etc.)
• Relevant experience of Pharmacovigilance
• Excellent interpersonal, verbal and written communication skills
• Ability to plan, organize, prioritize, and execute multiple tasks within assigned objectives
• Ability to work effectively in an international matrix team and value the importance of teamwork
• You can deal with peaks in the planning, a high workload and the ad-hoc and fast paced nature of biotech
• Fluent knowledge of English (written and oral)
• Advanced knowledge of MS Office (Word, PowerPoint, Excel)
- Salary at market level, depending on education and working experience
- Company pension scheme (100% contribution by employer)
- Mobile phone
- 1st class public transportation or travel allowance of Euro 0,19 per km
AM-Pharma is a clinical-stage biopharmaceutical company developing proprietary recombinant human Alkaline Phosphatase (AP) therapeutics. Its most advanced asset, known as Ilofotase Alpha (or recAP), is a fully human recombinant form of AP. In 2018, the company successfully completed a Phase IIb trial in sepsis-associated acute kidney injury patients (SA-AKI). The focus has since been on funding and execution of the Phase III / registration trial and preparation for launch. The company is gearing up to build the organization that will deliver on the next phase of evolution.
The new AM-Pharma organization has involved several new key positions with large pharma / biotech Phase III experience. The focus will be on Operational Excellence and flawless execution of pivotal studies with the objective to deliver a quality market authorization submission package and to be ready for launch. The bandwidth of the organization will allow for expanding the pipeline and/or accommodating new strategic opportunities.
About the setting
At AM-Pharma, we are actively conducting a global Phase III program treating critically ill patients with acute kidney injury in partnership with a clinical research organization. The pharmacovigilance is conducted by our partner and AM-Pharma provides the oversight. In addition, we are in the process of starting clinical research in a second and third indication and this will likely be executed in the same format. We have also started our preparations for commercial readiness that includes the build of the appropriate pharmacovigilance organization. The Pharmacovigilance Associate reports into the Chief Medical Officer and will work closely together with the internal operational team and the pharmacovigilance organization of the CRO partner.
AM-Pharma company culture
The company culture of AM-Pharma is built on four important competences: Collaboration, Quality orientation, Accountability and Resilience. At AM-Pharma we work together in a constructive, collaborative and team-oriented way, towards achieving the company objectives without losing sight of our own objectives. We put the common interest of the company above our own individual interest.
We set high standards regarding the quality of our materials, processes, documentation and collaborations, the staff are motivated to deliver excellence whilst also working to continually improve the quality of our work. We are fully accountable for the things that are in our power and control while working on the goals of the organization. We have an obligation to proactively report, explain and justify the things we do. We accept responsibility for our performance and we are transparent about the results of our work. Finally, we understand how to cope effectively with setbacks and obstacles and overcome hurdles on our way to reach our common goal. We stay committed to agreed objectives and company culture despite resistance while having the strength to adjust our plans when necessary. We are tolerant to stress and we deal effectively with criticism and resistance, building on our own strength.
AM-Pharma is currently located in the brand-new World Trade Center Utrecht Central, adjacent to Utrecht Central Railway Station in the lively business heart of Utrecht, close to Amsterdam and Schiphol Amsterdam Airport.