Excelya is one of the leading CROs in Europe, founded in 2014 and headquartered in Paris. Our global team is composed of 900+ experts who understand the critical needs of clients and provide trial solutions across a broad spectrum of therapeutic areas.
We take an one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.
Excelya’s vision is to achieve new advances in the field of healthcare and expertise in research development. Our goal is to help our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together and to become the clinical research leader in Europe.
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 projects.
Excelya is currently seeking a freelancer Drug Safety Officer for a part-time position in Sofia, Bulgaria.
Main Responsibilities
- Maintain a functional connection with the EEA Qualified Person for Pharmacovigilance (QPPV) e.g. participating in regular Local Safety Officer (LSO) meetings.
- Implement and maintain a pharmacovigilance system for the client products authorized in the territory (in collaboration with corporate Patient Safety teams), ensure compliance with applicable regulatory and company requirements and maintain oversight of local deliverables delegated to service providers.
- Maintain quality management system related to the pharmacovigilance, including management of Standard Operating Procedures (SOPs), Associated Instructions (AIs) and documents (e.g. forms, templates) to describe local processes and requirements and perform regular gap analysis as needed in order to ensure alignment with global SOPs.
- Ensure timely management of deviations and risk mitigation by defining appropriate CAPAs and ongoing trend analysis as appropriate. Patient Support Programs/Market Research programs/Digital initiatives.
- Proactive assessment of the capability and capacity of PSP/MRP vendors to conduct critical pharmacovigilance tasks (in support of qualification audits) and avoid issues of regulatory compliance. Proactive Regulatory Intelligence.
- Maintain thorough knowledge of the local current pharmacovigilance regulatory requirements and landscape plus proactively monitor for emerging regulations and communicate such to corporate teams (including EEA QPPV), local stakeholders.
- Knowledge of product safety risks to act proactively and independently with local stakeholders and proactively escalate local safety issues to the Safety Leads as appropriate.
- Champion the coordination and enable effective safety communication to HAs/HCPs and patients and ensure appropriate follow-up Health Authority inspections and Audit readiness.
- Ensure inspection and audit readiness of the relevant local departments in full collaboration with corporate Patient Safety and Quality Assurance.
- Act as local Subject Matter Expert on product safety, contributing to the product lifecycle activities, product information (e.g. labelling review) and risk management e.g. recalls, DHCP letters, implementation of Risk Management Plan as applicable.
