Responsible Person for Pharmacovigilance

h3Responsible Person for Pharmacovigilance /h3pJob details /ppbWork

location:
/bMesagne (BR), Italy, or fully remote /ppClinOpsHub S.r.l., founded in 2014 by Stefano Lagravinese, is a Contract Research Organization (CRO) self-certified with AIFA since 2019. /ppWe are a recognized partner in the Clinical Research sector, providing services to pharmaceutical companies, investigational sites, laboratories, and other CROs, with a strong focus on quality, innovation, and professional development. /ph3bRole and objectives /b /h3pWe are looking for an experienced bResponsible Person for Pharmacovigilance /bwith a strong background in pharmacovigilance activities within clinical trials. /ppThe successful candidate will be responsible for coordinating and overseeing ClinOpsHub’s pharmacovigilance activities, ensuring compliance with applicable regulatory requirements and contractual agreements with Sponsors. /ppThe role involves managing the Pharmacovigilance Quality System, overseeing adverse event management and reporting processes, and coordinating personnel involved in clinical trial safety activities. /ppThe Responsible Person for Pharmacovigilance will collaborate with internal teams and external stakeholders, providing subject matter expertise in pharmacovigilance across multiple projects. /ph3bMain responsibilities /b /h3pThe Responsible Person for Pharmacovigilance will be responsible for the following activities: /pulliManaging and maintaining ClinOpsHub’s Pharmacovigilance Quality System, ensuring compliance with applicable regulatory requirements and overseeing the maintenance and updating of relevant Standard Operating Procedures (SOPs). /liliManaging ClinOpsHub’s registration in EudraVigilance for activities performed on behalf of Sponsors, as required by individual projects. /liliPerforming pharmacovigilance activities as defined in contractual agreements, in compliance with Regulation (EU) No. 536/2014 and applicable guidelines. /liliEnsuring that Service Provider Agreements and Safety Management Plans (SMPs) are aligned with Sponsor requirements. /liliDeveloping and implementing study-specific Safety Management Plans, defining adverse event management workflows and related responsibilities. /liliSupervising and coordinating pharmacovigilance personnel, ensuring appropriate training on company procedures, study protocols, and study-specific work instructions. /liliOverseeing adverse event management activities and ensuring compliance with established timelines for the assessment, processing, and reporting of safety cases. /liliManaging and supervising SUSAR reporting processes to EudraVigilance, including procedures for accessing randomization codes, where applicable. /liliDeveloping and maintaining operational tools required for pharmacovigilance activities, including databases, tracking logs, and Serious Adverse Event (SAE) reporting forms. /liliMonitoring activities in accordance with the Safety Management Plans and providing regular status updates to Project Managers and pharmacovigilance personnel. /liliOverseeing safety data reconciliation activities and verifying data consistency with relevant study documentation. /liliMonitoring changes in pharmacovigilance regulations and assessing their impact on company procedures and ClinOpsHub’s annual Training Program. /liliProviding support during audits, inspections, and other regulatory activities. /liliEnsuring business continuity for pharmacovigilance activities through appropriate backup and emergency management arrangements, including 24/7 coverage where required. /liliEnsuring that personal data are managed in accordance with GDPR and company procedures. /liliCollaborating with other internal and external ClinOpsHub stakeholders, providing pharmacovigilance subject matter expertise. /li /ulh3bRequired qualifications and skills /b /h3ulliBachelor’s degree in Life Sciences or a related scientific or healthcare discipline; an advanced degree is preferred. /liliAt least 2 years of professional experience in pharmacovigilance, preferably in a pre-marketing or clinical trial setting, gained within a CRO, pharmaceutical company, or equivalent organization. /liliExperience in managing pharmacovigilance processes and knowledge of global pharmacovigilance systems, extending beyond individual case safety processing. /liliStrong knowledge of applicable Italian and European pharmacovigilance legislation, regulatory requirements, and relevant guidelines. /liliFluency in English. /liliPrevious experience in the use and management of pharmacovigilance safety databases and regulatory safety reporting systems. /liliPossession of the EudraVigilance training certificate: “Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands‑on training course on using the EudraVigilance system”. /liliKnowledge of the MedDRA Medical Dictionary for Regulatory Activities. /liliFamiliarity with SUSAR reporting procedures to EudraVigilance. /liliProficiency