Responsible Person Pharmacovigilance

Position: Responsible Person for Pharmacovigilance
Location: Leivi

Responsible Person for Pharmacovigilance  Job details

Work location:

Mesagne (BR), Italy, or fully remote
Clin Ops Hub  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 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. 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 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…