Remote Clinical Trials PV Operations Manager

Chiesi; Parma; Ibrido; EUR 41.000 - 51.000; Tempo pieno

Vantaggi offerti da questo lavoro

pension

private medical insurance

wellbeing programme

flexible benefits programme

comprehensive healthcare programs

work-life balance initiatives

robust relocation support

flexible working arrangements

remote work options

tax assistance services for foreigncol

Descrizione del lavoro

Chiesi Parma headquarters is seeking a Clinical Trials Manager to lead pharmacovigilance operations for interventional trials. You will support the CT PV OPS Head, maintain PV processes, oversee vendor activities, and train staff while ensuring data integrity and regulatory compliance.

The role requires a Master’s degree in a relevant field, 4+ years in R&D with PV/CR experience, and fluent English. Hybrid work arrangement and a competitive compensation package are offered.

Competenze

• Master’s degree in science, medicine, biology, pharmacy or related fields.
• Minimum 4 years of experience in R&D within Pharmaceutical/Biotech, with at least 3 years in Pharmacovigilance or Clinical Research.
• Fluent English and excellent communication skills.

Mansioni

• Carry out PV (pharmacovigilance) operations activities for interventional CTs.
• Support CT PV OPS Head to ensure PV requirements are integrated into processes and procedures.
• Provide training and oversee vendor staff; ensure CAPA and deviations are handled.
• Interact with safety science and Case Management teams; support PVSP activities.
• Oversee PV operations in CROs; ensure PV data is captured and documented.
• Lead audits/inspections readiness for PV processes and related documents.

Conoscenze

PV Operations

Clinical Trials

GCP knowledge

MedDRA knowledge

English fluency

Formazione

Master's degree in science/medicine/biology/pharmacy

Descrizione del lavoro

Chiesi Parma headquarters is seeking a Clinical Trials Manager to lead pharmacovigilance operations for interventional trials. You will support the CT PV OPS Head, maintain PV processes, oversee vendor activities, and train staff while ensuring data integrity and regulatory compliance.

The role requires a Master’s degree in a relevant field, 4+ years in R&D with PV/CR experience, and fluent English. Hybrid work arrangement and a competitive compensation package are offered.