PATIENT SAFETY MANAGER

Almirall; Sant Feliu de Llobregat; Presencial; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

Almirall seeks a Patient Safety Manager responsible for overseeing pharmacovigilance activities across the organization. You will manage clinical trials and post-marketing safety, ensuring compliance with regulations and contributing to a robust safety management system. This mid-senior level role at a top employer in Spain offers the opportunity to make a significant impact on patient safety.

Servicios

Opportunity to work with a leading pharmaceutical company

Career development and training programs

Formación

• Minimum 5 years of PV experience required.
• Relevant education including a Science Degree and postgraduate training preferred.

Responsabilidades

• Manage corporate pharmacovigilance activities.
• Oversee clinical trial activities including SAE management.
• Support post-marketing safety surveillance.

Conocimientos

Pharmacovigilance

Data Management

Safety Monitoring

Educación

Science Degree

Post-graduate training in pharmacovigilance

Herramientas

Safety databases

Descripción del empleo

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Mission

Patient safety. Management of corporate pharmacovigilance activities in collaboration with different internal and external stakeholders to ensure the safety of the assigned Almirall marketed or investigational products.

Tasks and Responsibilities

Operational support to clinical trial activities including but not limited to SAE management, reconciliation, unblinding activities as well as support in safety monitoring activities during development.

For clinical trials, responsible for management of Aggregate Reports (DSUR), and any other periodic reports required by regulators to ensure data completeness by the time of data lock point as well as providing tables and listings needed for the reports.

Revision of the synopsis, safety section of the protocols, safety section of the Data Management Plan, Safety Topics of Interest, and is accountable for the RSI of the study.

Lead the creation of the Safety Reporting Plan.

Active participation in the clinical study team meetings internal and with the CRO.

Operational support to non-interventional studies, market research, registries activities etc. including but not limited to ICSR management, reconciliation, as well as support in safety monitoring activities.

Post-marketing safety surveillance activities.

Supports the Patient Safety Director and EUQPPV to fulfil her internal duties as well as her responsibilities towards authorities.

Contributes to the establishment and performance of the Pharmacovigilance Quality Management System, and implements the procedures required by internal and applicable legislation.

Safety database tasks as applicable.

Education

Science Degree.

Relevant post-graduate training in pharmacovigilance and / or clinical safety and / or epidemiology preferred.

Specific Knowledge

Safety databases.

GVPs and other regulations as needed.

Experience

Minimum 5 years of PV experience.

Clinical safety in a corporate safety department is appreciated.

Why working with Almirall? We are a people-centric company where employees are at their best, patients and customer are at the heart of every decision, and our focus and agility allow us to deliver greater impact for all.

Additionally, for the 16th year in a row, we have been certified as Top Employer Spain!

This reaffirms our commitment to create a unique work environment that allows our employees to develop their skills to the fullest and grow both professionally and as individuals. We are thankful 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 success & 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! #wearealmirall

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Research and Science

Pharmaceutical Manufacturing and Biotechnology Research

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