Responsible Person For Pharmacovigilance

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Responsible Person for Pharmacovigilance
Job details
Work location: Mesagne (BR), Italy, or fully remote
Clin Ops Hub S.r.l., founded in **** by Stefano Lagravinese, is a Contract Research Organization (CRO) self-certified with AIFA since ****.
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 Clin Ops Hub'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 Clin Ops Hub's Pharmacovigilance Quality System, ensuring compliance with applicable regulatory requirements and overseeing the maintenance and updating of relevant Standard Operating Procedures (SOPs).
Managing Clin Ops Hub's registration in Eudra Vigilance 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. ******** 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 Eudra Vigilance, 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 Clin Ops Hub'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 Clin Ops Hub 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 Eudra Vigilance training certificate: "Mandatory use of ISO/ICH E2 B(R3) individual case safety reporting in the EU: hands?on training course on using the Eudra Vigilance system".
Knowledge of the Med DRA Medical Dictionary for Regulatory Activities.
Familiarity with SUSAR reporting procedures to Eudra Vigilance.
Proficiency in data management and analysis.
Ability to manage multiple projects simultaneously and meet established deadlines.
Strong organizational, analytical, and problem?solving skills.
Excellent communication, coordination, and leadership skills.
Ability to work both independently and collaboratively within multidisciplinary teams.
Residence or domicile within the European Union or European Economic Area (EU/EEA).
This job posting is open to candidates of all genders, ages, and nationalities (Italian Legislative Decree ******** and Directive *******/EC).
Clin Ops Hub actively promotes diversity: where candidates have equivalent qualifications, priority may be given to applicants from groups underrepresented within the team.
Privacy
Personal data will be processed in accordance with Regulation (EU) ******** (GDPR) and applicable data protection legislation.
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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/89oztv