Senior Pharmacovigilance Lead — PV Quality & Compliance (Remote)

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

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