Responsible Person for Pharmacovigilance

ClinOpsHub S.r.l.; Brindisi; Remoto; EUR 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

ClinOpsHub S.r.l. is seeking an experienced Responsible Person for Pharmacovigilance to coordinate and oversee all PV activities for multiple projects.

The role requires maintaining the PV Quality System, SOPs, and ensuring compliance with EU regulations and Sponsor contracts. Responsibilities include managing EudraVigilance registrations, SUSAR reporting, PV training, and safety data reconciliation, with strong leadership and communication skills essential for collaboration across teams and

Competenze

• Bachelor’s degree in Life Sciences or related field; advanced degree preferred.
• At least 2 years of professional experience in pharmacovigilance, preferably in CRO/pharma settings.
• Strong knowledge of Italian and European pharmacovigilance legislation and guidelines.
• Fluency in English.
• Experience with pharmacovigilance safety databases and regulatory safety reporting systems.
• EudraVigilance training certificate required.
• Knowledge of MedDRA.
• Familiarity with SUSAR reporting to EudraVigilance.
• Proficiency in data management and analysis.
• Ability to manage multiple projects and meet deadlines.
• Strong organizational, analytical, and problem-solving skills.
• Excellent communication, coordination, and leadership abilities.
• EU/EEA residence or domicile.

Mansioni

• Coordinate and oversee ClinOpsHub’s pharmacovigilance activities.
• Develop and maintain the Pharmacovigilance Quality System and SOPs.
• Register in EudraVigilance for Sponsor projects.
• Perform PV activities per contracts and EU Regulation 536/2014 and guidelines.
• Align SPAs and Safety Management Plans with Sponsor requirements.
• Develop study-specific Safety Management Plans and workflows.
• Supervise PV personnel and provide training on procedures and study protocols.
• Oversee adverse event management and reporting timelines.
• Manage SUSAR reporting to EudraVigilance and access to randomization codes where applicable.
• Create and maintain operational PV tools (databases, logs, SAE reporting forms).
• Monitor activities per Safety Management Plans and report to Project Managers.
• Ensure data reconciliation and consistency with study documents.
• Stay updated on PV regulations and impact on procedures and training.
• Support audits and inspections; ensure business continuity and GDPR compliance.
• Collaborate with internal/external stakeholders to provide PV SME input.

Conoscenze

Pharmacovigilance experience

English fluency

Regulatory knowledge

Formazione

Bachelor’s degree in Life Sciences

Advanced degree preferred

Strumenti

EudraVigilance

Safety databases

Regulatory reporting systems

Descrizione del lavoro

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 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 198/2006 and Directive 2000/78/EC).

ClinOpsHub 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) 2016/679 (GDPR) and applicable data protection legislation.