Excelya, one of the leading independent CRO in Europe.
Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.
We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 900 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.
For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.
To learn more about us, visit www.excelya.com.
The role:
Exceya is looking to collaborate with a Freelancer for an indefinite duration, full-time (1 FTE) role of Safety Officer (LSO) based in Denmark. Excellent knowledge of the English and local language are required for this role.
The Safety Officer (SO) is responsible for the handling of product safety (e.g. pharmacovigilance, device or cosmeto- vigilance) issues within Excelya PV & Safety team. The SO maintains required level of understanding of the regional/national/international vigilance legislation. He/she is accountable for safety processing, assessment, coding and reporting activities in compliance with the client’s and/or EXCELYA’s SOPs and applicable safety legislation
General Responsibilities/Tasks:
1. Follows EXCELYA and Client policies, procedures, instructions, guidance.
2. Maintain required level of understanding of the regional/national/international vigilance legislation.
3. Follows good documentation practices (including policies, procedures and practices for filing, storage and tracking of vigilance records).
4. Ensure data privacy requirements are met, in accordance with EXCELYA/Client procedures and any applicable regional and national regulations he/she is trained to.
5. Participates in trainings and completes all training assignments within the defined timelines.
6. Participates in web calls/teleconferences/meetings/audits/inspections.
7. Maintain Curriculum Vitae and training records up-to-date.
8. Escalates detected deviations, non-compliances, findings and issues.
9. Operates 24/7 safety phone line and is responsible for its proper function (including voice mail or diversion activation/deactivation as necessary) and for escalation of any issues.
10. Ensures proper delegation of responsibilities/tasks where and when applicable.
11. Collects, documents, assess, forwards, follow-up, (responds (where applicable)) and reports appropriately and within agreed/required timelines, case reports, complaints, queries and requests (including information about any issue of potential or actual media/public interest; including information about any potential or actual legal action or liabilities).
12. Operates electronic systems and databases for case processing, coding, safety reporting to the relevant Authorities and product/company/individual/document registration.
13. Reports timely to the authorities, as applicable.
14. Maintains tracking systems (e.g. adverse event/query/complaints lists, journal lists, product lists, project lists, submission lists etc.).
15. Monitors changes in local or non-local vigilance related legislation (including guidelines, circulars, directives, initiatives etc.) and notifies timely external/internal stakeholders.
16. Updates/reviews quality management system documents.
17. Performs filing/storage/tracking of internal/external communication and of vigilance records (including source files) as applicable; forwards physical or electronic files to Clients or internally as applicable.
18. Performs internal/external reconciliation as applicable.
19. Submits or assists for submission of vigilance related documents and reports, including preparation of cover letter(s) as applicable; follows up submissions and informs Clients or internal stakeholders as applicable.
20. Handles communication with external stakeholders (Clients, regulators, local collaborators etc.).
21. Ensures that all reference safety information is communicated to applicable stakeholders appropriately.
22. Performs review/quality control to vigilance related documents (including coding).
23. Organizes and conducts trainings on general vigilance requirements or trainings specific to his/her expertise.
24. Oversees that all stakeholders involved in the handling of safety information are trained and fully aware of their project related responsibilities and processes.
25. Provides input to safety data exchange agreements as to address the responsibilities of each party for the fulfilment of pharmacovigilance or other product safety obligations.
26. Performs translations or quality control on translations (according to own language competencies).
27. Performs literature search in (and maintain access to) databases/global sources; perform review or quality control to the results.
28. Prepares aggregate safety reports.
29. Prepares Risk Management Plans (RMPs)/Trend reports, assists in or handles communication of new safety information, ensures local RMP implementation, performs risk management/minimisation activities and monitors compliance/effectiveness of the activities, for products of PV&SD Clients.
30. Performs risk-benefit assessment/signaling.
31. Prepares and maintains the PV System Master File/Safety Management Plan.
32. Monitors generic mailbox(es).
LSSO Responsibilities/Tasks:
When performing also as Local Specialist Safety Officer-LSSO (or LSSO back-up/deputy), in addition to the above listed:
1. Is continuously and permanently available for all interested parties where required/requested or else ensures proper handover.
2. Performs local literature search/review or quality control on results, maintain local journal/conference lists.
3. Is the contact person for local competent authorities regarding vigilance issues (or the back-up contact person).
4. Communicates to Competent Authorities of LSSO nomination and contact details.
5. Has an overview at the required level of understanding of the safety profiles and any emerging safety concern for products for which he/she is a nominated (to the authority or to the Client) LSSO.
6. Provide reports on performed activities, as applicable.
7. Where required signs vigilance related documents and reports for submission to local competent authorities.
8. When acting in the role of back-up/deputy or only in the role of back-up/deputy, assumes all hand overed or delegated tasks/responsibilities and acts as back up person of the LSSO (for all LSSO tasks/responsibilities).
9. When acting only in the role of back-up/deputy, the responsibilities listed above in 4 is assumed by primary LSSO(s) if not hand overed/delegated.
10. Within European Economic Area pharmacovigilance system, the LSSO reports directly or indirectly to the European Union Qualified Person responsible for Pharmacovigilance.
Education and Experience
