Responsible Person for Pharmacovigilance

Responsible Person for Pharmacovigilance Job details
Work location: Mesagne (BR), Italy, or fully remote
ClinOpsHub S.r.l., founded in 2014 by Stefano Lagravinese, is a Contract Research Organization (CRO) self-certified with AIFA since 2019.
We 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.
Role and objectives We are looking for an experienced Responsible Person for Pharmacovigilance with a strong background in pharmacovigilance activities within clinical trials.
The successful candidate will be responsible for coordinating and overseeing ClinOpsHub’s pharmacovigilance activities, ensuring compliance with applicable regulatory requirements and contractual agreements with Sponsors.
The role involves managing the Pharmacovigilance Quality System, overseeing adverse event management and reporting processes, and coordinating personnel involved in clinical trial safety activities.
The Responsible Person for Pharmacovigilance will collaborate with internal teams and external stakeholders, providing subject matter expertise in pharmacovigilance across multiple projects.
Main responsibilities The Responsible Person for Pharmacovigilance will be responsible for the following activities:
Managing 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).
Managing ClinOpsHub’s registration in EudraVigilance for activities performed on behalf of Sponsors, as required by individual projects.
Performing pharmacovigilance activities as defined in contractual agreements, in compliance with Regulation (EU) No. 536/2014 and applicable guidelines.
Ensuring that Service Provider Agreements and Safety Management Plans (SMPs) are aligned with Sponsor requirements.
Developing and implementing study-specific Safety Management Plans, defining adverse event management workflows and related responsibilities.
Supervising and coordinating pharmacovigilance personnel, ensuring appropriate training on company procedures, study protocols, and study-specific work instructions.
Overseeing adverse event management activities and ensuring compliance with established timelines for the assessment, processing, and reporting of safety cases.
Managing and supervising SUSAR reporting processes to EudraVigilance, including procedures for accessing randomization codes, where applicable.
Developing and maintaining operational tools required for pharmacovigilance activities, including databases, tracking logs, and Serious Adverse Event (SAE) reporting forms.
Monitoring activities in accordance with the Safety Management Plans and providing regular status updates to Project Managers and pharmacovigilance personnel.
Overseeing safety data reconciliation activities and verifying data consistency with relevant study documentation.
Monitoring changes in pharmacovigilance regulations and assessing their impact on company procedures and ClinOpsHub’s annual Training Program.
Providing support during audits, inspections, and other regulatory activities.
Ensuring business continuity for pharmacovigilance activities through appropriate backup and emergency management arrangements, including 24/7 coverage where required.
Ensuring that personal data are managed in accordance with GDPR and company procedures.
Collaborating with other internal and external ClinOpsHub stakeholders, providing pharmacovigilance subject matter expertise.
Required qualifications and skills Bachelor’s degree in Life Sciences or a related scientific or healthcare discipline; an advanced degree is preferred.
At 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.
Experience in managing pharmacovigilance processes and knowledge of global pharmacovigilance systems, extending beyond individual case safety processing.
Strong knowledge of applicable Italian and European pharmacovigilance legislation, regulatory requirements, and relevant guidelines.
Fluency in English.
Previous experience in the use and management of pharmacovigilance safety databases and regulatory safety reporting systems.
Possession 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”.
Knowledge of the MedDRA Medical Dictionary for Regulatory Activities.
Familiarity with SUSAR reporting procedures to EudraVigilance.
Proficiency in data management and analysis.
Ability to manage multiple projects simultaneously