Overview
Support Corporate Patient Safety and pharmacovigilance activities under supervision, collaborating with internal teams and external partners to ensure product safety for Almirall’s marketed and investigational products.
Responsibilities
* Clinical Safety (Clinical Trials)
o Assist in coordinating the Safety Reporting Plan and other PV documents between CROs and Almirall.
o Support basic tasks related to coding review, protocol revisions, and follow-up meetings.
o Help prepare presentations and review aggregated safety data under supervision.
* Post-marketing Safety
o Provide support in preparing periodic safety reports (PSURs), Risk Management Plans (RMPs), and other safety documents such as signal detection reports.
o Assist Pharmacovigilance Activity (PVA) updates and tracking maintenance.
o Support electronic archiving and internal process tracking.
* Quality Management System
o Assist and participate in the Company’s procedures updates to ensure processes are consistent with current business rules and industry practices in both post-marketing and clinical activities.
o Support updates of the Pharmacovigilance System Master File (PSMF) and annexes.
o Assist in preparing metrics and compliance reports required for KPI monitoring.
o Help with administrative tasks for audits and inspections.
o Maintain deviations of the pharmacovigilance system related to the safety database and monitor that CAPAs are actioned by established deadlines.
* Global Safety Database
o Provide support as a user for database updates and libraries maintenance.
* Innovation and Technology
o Learn about new technologies applied to pharmacovigilance and support evaluation and improvement of processes under supervision.
Education
Degree in Life Sciences or related field.
Specific expertise
Knowledge: Basic understanding of pharmacovigilance appreciated. Languages: Professional fluency in English.
Skills
Basic knowledge of IT, willingness to learn, teamwork. Support Corporate Patient Safety and pharmacovigilance activities under supervision, collaborating with internal teams and external partners to ensure product safety for Almirall’s marketed and investigational products.
Why work with Almirall?
We are a people-centric company where employees are at their best, patients and customers are at the heart of every decision, and our focus and agility allow us to deliver greater impact for all. Additionally, for the 17th year in a row, we have been certified as Top Employer Spain, and also Top Employer Germany for the first time. This strengthens our commitment to create a unique work environment that helps our employees to develop their skills to fullest and grow both professionally and as individuals. We are delighted to have a great team that is proactive, innovative, and eager to transform the world of people with skin conditions. We are proud of each one of our employees, their development, and growth: they are the success of the company.
Our purpose: Transform the patients\' world by helping them realize their hopes & dreams for a healthy life.
Our values
* Care: we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.
* Courage: we challenge the status quo, we take full ownership and we learn from our successes & failures.
* Innovation: we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets.
* Simplicity: we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.
At Almirall, it’s all about people!
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