Pharmacovigilance Specialist

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 your area, specify new processes and standards to secure the license to operate, ensure the continuity of all PV activities in Spain, and assume the role of Safety Contact Person (SCP).

Responsibilities include :

• Ensure local PSMF are updated and available upon request from HA.
• Be available for the EU QPPV when needed.
• Support updates of the Global PSMF.
• Ensure a local continuity plan is 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 audits and lead local inspections.
• Bridge local to global and global to local communications regarding transformations and changes.
• 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.
• Maintain necessary local records, if relevant.
• Manage PV for PSP, MR, and stay informed about IIS initiatives, communicating accordingly.
• Prepare and validate local PV contracts.
• Distribute information to relevant persons and alert in case of possible signals.
• Oversee monitoring of LEO Pharma social media.

Qualifications :

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