YOUR QUALIFICATIONS

• Bachelor’s or Academic degree in life sciences, with a minimum of 3 years’ experience in pharmacovigilance (post-marketing and clinical trials)
• Good knowledge of local and EU PV regulationsFluent English – strong oral and written communication skils

YOUR ROLE

As Pharmacovigilance (PV) Specialist, you will follow the strategic direction of LEO Pharma’s Safety and Regulatory Affairs team, including the establishment and maintenance of globally and locally (when needed) standardized practices, to ensure compliance with international and national regulations. This role additionally supports overall corporate business strategy through tactical short and long term strategies, acknowledging local obligations and strategies, while ensuring the continuity of PV activities.
The PV Specialist will also assume the role of deputy Safety Contact Person (dSCP), acting as a qualified health care professional assessing lack of efficacy (LOE) cases for unusual failure in efficacy (UFIE). This is a fixed term contract role, beginning May 2025 through August 2025.

YOUR RESPONSIBILITIES

• Support update of Global PSMF; ensure there is a continuity plan in place
• Responsible for Pharmacovigilance (PV) interface with local health authorities
• Responsible for PV training of partners and LEO Pharma employees
• Support audit & inspections
• Bridge local to global and global to local teams by communicating transformations and changes related to the local Safety organization
• Identify and implement improvements for PV processes and procedures
• Create and update local SOPs and Wis to align with local/global legislation and company requirements
• Process safety information from spontaneous or solicited cases
• Perform reconciliation with all sources of PV cases
• Ensure regulatory reporting of cases from interventional clinical trials including development safety update report (DSUR)
• Perform regulatory surveillance of PV
• Maintain needed records
• Manage PV for PSP, MR and keep informed about IIS.
• Prepare and validate local PV contracts
• Distribute to relevant persons and alert in case of possible signals