Senior PV Operations Manager — Clinical Trials (Hybrid)

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

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Wellbeing programme

Relocation support

Descrizione del lavoro

Chiesi Group in Parma, Italy, is seeking a Pharmacovigilance Operations professional to support PV activities in interventional clinical trials, collaborating across international teams. The role focuses on implementing PV requirements, delivering high-quality safety data, and ensuring compliance.

You will lead training, oversee CROs, participate in audits, and drive process improvements while maintaining rigorous standards in regulatory adherence.

Competenze

• Master degree in science, medicine, biology, pharmacy or related fields.
• Minimum 4 years in R&D within Pharmaceutical/Biotech, with at least 3 years in PV or Clinical Research.

Mansioni

• Support the PV OPS CT Head to ensure PV requirements for interventional trials are incorporated into processes and documented.
• Ensure collection and delivery of high-quality clinical trial safety data in a timely, compliant manner for agencies.
• Engage CT customers, affiliates and other stakeholders.
• Act as owner for processes under the CT PV OPS Unit, including training, procedure maintenance and vendor oversight.
• Provide training to internal and vendor staff on these processes.
• Support Case Management activities for PVSPs.
• Interface with Safety Science for data inputs on product safety strategy.
• Oversee PV operations with CROs and ensure data in PV-related documents is complete.
• Open deviations and contribute to CAPA plans and investigations.
• Manage PV OPS activities through post-integration phases for R&D assets.
• Support audits and inspections as PV expert; participate in process improvements.
• Maintain compliance with regulations, policies and procedures.

Conoscenze

Excellent communication

Interpersonal skills

Initiative and autonomy

Problem solving

Planning and analytical skills

International environment adaptability

Formazione

Master's degree in science/medicine/pharmacy

Descrizione del lavoro

Chiesi Group in Parma, Italy, is seeking a Pharmacovigilance Operations professional to support PV activities in interventional clinical trials, collaborating across international teams. The role focuses on implementing PV requirements, delivering high-quality safety data, and ensuring compliance.

You will lead training, oversee CROs, participate in audits, and drive process improvements while maintaining rigorous standards in regulatory adherence.