Company Description At LEO Pharma, we strive to pioneer future change by providing treatment solutions to people living with skin conditions worldwide. We believe that our employees form the basis of our success and are our greatest asset. Thanks to our inclusive work environment and diverse teams, LEO Pharma is a workplace where innovation thrives, and people grow. We help people with skin diseases live fulfilling lives by advancing dermatology beyond the skin. We drive dermatology with our knowledge, collaboration and curiosity. We are at the forefront of science in developing new medicines for dermatology. Each one of us at LEO Pharma can make a real impact in our everyday work. Together, we explore new ideas and make them happen.
We do this through mutual respect and a shared sense of purpose, rooted in our caring culture and a commitment to helping others. For us, pioneering together is about constantly improving and extending what's possible for each other, our company, and our patients.
LEO Pharma is searching for a Pharmacovigilance & Medical Information Officer. The position is based in Barcelona and has an Iberia scope (ES&PT) and will report to the Iberia Medical Director.
Your main tasks will include: To ensure smooth day to day of pharmacovigilance function within LEO Pharma Spain & Portugal according to pharmacovigilance regulations.
Identify and provide Medical Information as well as solve the request of medical queries received in LEO Spain & Portugal from Health Care Professionals and partners.
Pharmacovigilance: Perform duties acting under the guidelines of the medical department strategy.
Act as Pharmacovigilance Officer, Safety Contact Person (SCP) Spain and Deputy Safety Contact Person (dSCP) Portugal.
Perform Individual Case Safety Report (ICSR) and other experiences.
Supervise the safety post authorization studies.
Close processed ICSRs/Other experiences generated in Spain & Portugal.
Report spontaneous ICSRs to Corporate Pharmacovigilance in due time and support them for electronic reporting to the Spanish & Portuguese Health Authorities.
Cooperate with the autonomous drug safety centers regarding drug safety issues.
Manage and answer any information requested from the health authorities regarding drug safety.
Track all reports and perform reconciliation with business partners.
Assist with pharmacovigilance processes, supporting preparation of SOP's, product safety reviews and literature reviews as required.
Review local literature screening search results, identifying ICSRs and other safety-related findings.
Maintenance and updating of Pharmacovigilance documentation.
Periodic pharmacovigilance training to LEO ES employees.
Medical Information: Provide Medical Information to external and internal customers.
Resolution of medical queries received in LEO Spain & Portugal in close collaboration with Scientific Affairs colleagues.
Management of PubMed and up-to-date databases.
Track all Medical queries in Medical Information Inquiry Database.
Assist with Medical Information processes, supporting revision and update of procedures.
Training other departments, if required.
Qualifications Profile qualifications:
University Degree - Life Science Graduate.
Fluent in English and Spanish (written and spoken).
Experience in Pharmacovigilance or related Scientific area (at least 2 years).
Computer Knowledge.
Good Industry Knowledge.
Ability to manage multiple and varied tasks and prioritize workload with attention to detail.
Competences:
Drives Results.
Customer Focus.
Collaborates.
Nimble Learning.
Secondary Competencies:
Communicates Effectively.
Action Oriented.
LEO Pharma promotes internal promotion and mobility between different functions. At LEO we value our people, we recognize their performance and reward achievements.
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