Pharmacovigilance Specialist

Location: Barcelona 08003, Barcelona, Spain 
Contract type: Permanent 
Job ID: 3342 

Shape the LEO Pharma of tomorrow

At LEO Pharma, our mission transcends the conventional. We're on an ambitious path to become the leaders in medical dermatology worldwide.

In the Safety department we share a “challenge accepted” mindset and are guided by our winning behaviors of simplification, collaboration, and accountability, to achieve our goals. 

As the Pharmacovigilance Specialist in Spain, you will get the opportunity to shape the future and help people with skin diseases live more fulfilling lives by advancing the standard of care.

Your role

The Pharmacovigilance Specialist follows the strategic direction for the establishment and maintenance of globally and when needed locally standardized practices to ensure compliance with international and national regulations. You will also support the corporate business strategy into tactical short- and long-term strategies acknowledging local obligations and strategies. Provide performance and compliance oversight for own area and specify new processes and standards to secure license to operate, ensure the continuity of all PV activities in Spain and assume the role of Safety Contact Person (SCP). 

In details: 

    • Ensure local PSMF are updated and available upon request from HA

    • Be available for the EU QPPV when needed

    • Support update of Global PSMF

    • Ensure to have a local continuity plan in place

    • Responsible for PV interface with local health authorities

    • Responsible for PV training of partners and LEO Pharma employees

    • Responsible for PV deliverables and effective performance management

    • Support audit & lead local inspections

    • Responsible for bridging local to global and global to local by communicating transformations and changes related to the local organization

    • Identify and implement improvements for PV processes and procedures

    • Process safety information from spontaneous or solicited cases

    • Ensure reconciliation with all sources of PV cases

    • Ensure regulatory reporting of cases from interventional clinical trials including DSUR

    • Ensure regulatory surveillance of PV

    • Maintain needed local records, if relevant

    • Manage PV for PSP, MR and keep informed about IIS. Ensure to communicate about the initiatives

    • Prepare and validate local PV contracts

    • Distribute to relevant persons and alert in case of possible signals 

    • Responsible for overview of who is monitoring LEO Pharma social media

Your qualifications 

To succeed in this role, we imagine that you have the following qualifications: 

    • Bachelor or Academic degree in life science, with a minimum of 5 years' experience in Pharmacovigilance (post-marketing and clinical trials)

    • Solid knowledge of local and EU PV regulations

    • Native Spanish speaker and full fluency in English – oral and written

    • Solid technical skills

Behavioural competencies:

    • We keep patients at the heart of what we do

    • We innovate and improve

    • We engage and enable our people

    • We collaborate across and beyond LEO

    • We execute and deliver

Contact and application

You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest.

Beyond the skin

Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact.  Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet. 
 
At LEO Pharma, we believe in the power of individuals to drive change. Our flat organizational structure empowers you to make a visible impact and offers versatile roles for professional growth. We value diversity and welcome applications from all qualified candidates, recognizing that our different perspectives, backgrounds, and attitudes enable us to make the best decisions. Join our passionate team at LEO Pharma and be yourself as we work together to make a difference.
 
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