Pharmacovigilance and Medical Information Specialist
hace 2 días
About LEO Pharma
LEO Pharma is a global leader in the development and marketing of innovative dermatological treatments. Our mission is to pioneer future change by providing treatment solutions to people living with skin conditions worldwide.
Job Summary
We are seeking a highly skilled Pharmacovigilance and Medical Information Specialist to join our team in Barcelona, Spain. As a key member of our Pharmacovigilance and Medical Information team, you will be responsible for ensuring the smooth day-to-day operation of pharmacovigilance functions within LEO Pharma Spain and Portugal.
Key Responsibilities
- Pharmacovigilance:
- Ensure compliance with pharmacovigilance regulations and guidelines.
- 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.
- 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.
Requirements
- 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.
Competencies
- Drives Results.
- Customer Focus.
- Collaborates.
- Nimble Learning.
Secondary Competencies
- Communicates Effectively.
- Action Oriented.
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