Local Safety Officer
A great career opportunity has emerged at a multinational pharmaceutical company that specialises in developing life-transforming therapies for patients with severe and life-threatening diseases. This Local Safety Officer job will be based at their office in Paris. The company offer an excellent working environment and opportunities for career development within the organisation.
- Developing and maintain effective business relationships with external parties in addition to tracking performance metrics including regulatory compliance.
- Following-up adverse events as necessary, providing new and updated information to GDS Maintains local source documents in accordance with applicable record retention requirements.
- Oversight of external party or parties where applicable within France and assigned countries, who are engaged in the collection, translation, entering of initial information into the form, as appropriate, that originates from any relevant PV data source, and onward forwarding of information to GDS.
- Acting as the local Qualified Person for Pharmacovigilance, in accordance with French regulations (article R. 5121-164 of French Public Health code).
- Ensuring business continuity for collection and reporting within the country or countries of responsibility.
- Acting as primary contact for GDS in France and countries of responsibility.
- Ensuring the intake of French PV calls from Switzerland.
- Executing CAPA plans relevant to the LSO role as necessary and oversees the development, implementation and execution of any necessary CAPA plans by third parties that support the LSO's area of responsibility.
- Ensuring local regulatory intelligence.
- Maintaining and seeking out a thorough understanding of global and local requirements that relate to the LSO role, identifying and communicating emerging needs to introduce process changes to remain compliant.
- Providing PV expertise to the selection and qualification of any Patient Support Program organised within the countries of responsibility and oversees PV activities related to Patient Support Program.
- Performing root cause analysis of deviations relevant to local PV processes.
- Point of contact to provide local expertise on reporting processes and standards to local country staff and related contractors/vendors according to standards and local regulations.
- Providing oversight for PV activities performed in other countries as required.
- Maintaining oversight of vendors relevant for PV and Handle Local Safety Data Exchange Agreements.
- Sharing best practices with other affiliates in the EMEA region.
- Streamlining and developing local processes as required.
- Supporting and overseeing local implementation of RMP.
- Performing Local literature screening (Local medical journals), including article request or ensures oversight of vendor performing local literature screening.
- Ensuring reconciliations with interfaces who shall receive potential adverse events (i.e. Medical Information, Quality complaints).
- Supporting Pharmacien and GDS during Pharmacovigilance audits and inspections.
Skills and Requirements:
- Pharm D or Medical doctor, registered to national professional council in accordance with the requirements for Local Qualified Person for Pharmacovigilance in France.
- Extensive experience in pharmaceutical industry experience or equivalent with majority of experience in a PV functional role.
- Fluency in English language required.
- Vendor management experience.
- Proven expertise and experience in pharmaceutical regulations and R&D processes.
- Proven ability to organise workflow activities and manage multiple critical issues.
- Awareness of and familiarity with industry principles of PV, drug development and pharmacology
- Computer literate with expert knowledge of PV database systems.
- Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external customers.
- Ability to establish and maintain open relationships within the local and global organizations and with local regulatory authorities.
- Demonstrable knowledge of all local PV requirements and of the global aspects of drug safety.
- Able to work independently.
- Strong interpersonal and influencing skills.
- Understanding of medical terminology and pharmacology.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Valaince Penteng at 0203 846 0643 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.